An Urgent Bulletin from CSA Group€¦ · edition adopted IEC 60601/80601 standards series; collaterals, particulars (part 2) standards and others Addition of new standards Standard

Visit us at www.csagroup.org where you can click on "Contact Us" for the online phone listing of our Offices and Partners.

DQD 529.02 Rev 2018-11-07 © CSA Group 2018. All rights reserved.

Page 1 of 24

Ref No: I19-044

HealthCare Equipment No. 34 (Supersedes Informs Health Care Equipment No 33, Ref No: I18-079)

New Service available as of today

Date: April 30, 2019 Apply any time to have your products evaluated

Announcing: New Collateral and Particular (Part 2) Standards and Re-affirmed 60601/80601 Series

See Attachment 1 for affected Class Numbers.

To purchase the Standard, visit us at store.csagroup.org

Who is affected?

Manufacturers of medical electrical equipment and diagnostic imaging and radiation therapy equipment, health care facilities and other interested users.

What do you do?

1. This publication provides for new certification services that do not affect your currently certified product designs.

2. Please contact CSA technical staff if you have questions or need information concerning this publication and how it applies to you.

3. If you would like to take advantage of the new certification services, initiate a certification project by contacting our Client Services Centre at 1-866-797-4272. Please supply appropriate supporting documentation* and we will inform you of the samples required.

*which includes technical information, company name, address, factory locations and CSA file number or master contract number (if assigned), and any other relevant documentation.

Introduction:

New Certification Services to the following Canadian Standards. See Attachment 2

Complete List of Applicable Canadian standards (Collaterals, Particulars and Others). See Attachment 3.

List of United States of America recognized standards (Collaterals, Particulars and Others). See Attachment 4

Background and Rationale:

See attachment 5

For questions specific to your file or products contact your CSA Group technical staff associate.

Go to https://www.csagroup.org/testing-certification/product-listing/ and enter your Master Contract # and the class numbers

associated with this Informs to view your certified products.

For technical questions on this Informs

Contact Michel Brossoit by phone 514-428-2411, fax 514-694-5001 or e-mail [email protected]

An Urgent Bulletin from CSA Group

http://www.csagroup.org/

https://store.csagroup.org/?cclcl=en_US

https://www.csagroup.org/testing-certification/product-listing/

https://www.csagroup.org/testing-certification/product-listing/

mailto:[email protected]

Page 2 of 24 DQD 529.02 Rev 2018-11-07

ATTACHMENT 1

Affected Class Numbers Class No: 5311 20, POWER SUPPLIES - Component Type - For Use in Medical Equipment 5311 28, POWER SUPPLIES - Component Type - For Use in Medical Equipment/System 5311 96, POWER SUPPLIES - Component Acceptance - Certified to US Standards 5311 98, POWER SUPPLIES - Component Type - For Use in Medical Equipment/System - Certified to US Standards 8731 01, DIAGNOSTIC IMAGING AND RADIATION THERAPY EQUIPMENT - 8732 01, DIAGNOSTIC IMAGING AND RADIATION THERAPY EQUIPMENT - Accessories 8750 01, MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS - 8750 02, MEDICAL ELECTRICAL EQUIPMENT - Electromechanical Lifting Devices 8780 01, MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS 8780 81, MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS - Certified to US Standards

ATTACHMENT 2

Introduction CSA New Services – New classes and Publications as per CAN/CSA-C22.2 No 60601/80601 2nd and 3rd edition adopted IEC 60601/80601 standards series; collaterals, particulars (part 2) standards and others

Addition of new standards

Standard Title

CAN/CSA-C22.2 NO. 60601-2-2:19

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (Adopted IEC

60601-2-2, edition 6.0, 2017-03)

CAN/CSA-C22.2 NO. 60601-2-3:14 +

AMD1:2019

Medical electrical equipment – Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment (Adopted ISO 60601-2-3:2012, third edition, 2012-04 +

amendment 1, 2016-04)

CAN/CSA-C22.2 NO. 60601-2-6:14 +

AMD1:2018

Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment (Adopted ISO 60601-2-6:2012, second edition, 2012-04 +


CAN/CSA-C22.2 NO. 60601-2-20:10 + AMD1:2019

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (Adopted IEC 60601-2-20:2009, second edition, 2009-02 +


CAN/CSA-C22.2 NO. 60601-2-28:18

Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Adopted IEC 60601-2-28:2010, third edition, 2017-

06)

CAN/CSA-C22.2 NO. 60601-2-43:11

+ AMD1:2019

Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (Adopted IEC 60601-2-43:2010, second edition,

2010-03 + amendment 1, 2017-08)

CAN/CSA-C22.2 NO. 60601-2-46:18 Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (Adopted IEC 60601-2-46, third edition, 2016-08)

Page 3 of 24 DQD 529.02 Rev 2018-11-07

CAN/CSA-C22.2 NO. 60601-2-50:10 + TC1:2011 + AMD1:2018

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (Adopted IEC 60601-2-50:2009, second edition, 2009-03 +


CAN/CSA-C22.2 NO. 80601-2-58:15 + AMD1:2019

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (Adopted IEC 80601-2-

58:14, second edition, 2014-09 + amendment 1, 2016-10)

CAN/CSA-C22.2 NO. 60601-2-63:15

+ AMD1:2019

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (Adopted IEC 60601-2-63:2012, first edition, 2012-09-19 +


CAN/CSA-C22.2 NO. 60601-2-65:15

+ AMD1:2019

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (Adopted IEC 60601-2-65:2012, first edition,2012-09 +


CAN/CSA-C22.2 NO. 80601-2-74:19 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (Adopted ISO 80601-2-74:2017, first edition, 2017-05)

CAN/CSA-Z10535.1:15 CAN/CSA-Z10535.1:15 - Hoists for the transfer of disabled persons — Requirements and test methods (Adopted ISO 10535:2006, second edition, 2006-12-15, with Canadian deviations)

ATTACHMENT 3

List of Canadian (CAN) Adopted IEC 60601/80601 Series

Standard Title

CAN/CSA-C22.2 NO. 60601-1:08 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005,

third edition, 2005-12) which incorporates Corrigendum 1:2006

CAN/CSA-C22.2 NO. 60601-1:08

TC 2:2011 (Corrigendum 2)

Technical Corrigendum 2:2011 to CAN/CSA-C22.2 No. 60601-1-08, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005, third edition, 2005-12)

CAN/CSA-C22.2 NO. 60601-1:08 +

AMD1:2014

CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005 edition 3.0 + AMENDEMENT 1,

2012-07, MOD)

CAN/CSA-C22.2 NO. 601.1-M90 (R05)

Medical Electrical Equipment - Part 1: General Requirements for Safety (Adopted IEC 601-1:1998 edition 2)

CAN/CSA-C22.2 NO. 601.1S1-94 (R1999)

Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90 - Medical Electrical Equipment - Part 1: General Requirements for Safety (Adopted IEC 601-1:1998 edition 2 + Amendment 1:1991)

CAN/CSA-C22.2 NO. 601.1B-90 (R06)

Amendment 2 to CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety (Adopted

Amendment 2:1995 to IEC 601-1:1990)

CAN/CSA-C22.2 NO. 60601-1-1-02 (2011)

Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems (Adopted IEC 60601-1-1:2000, second edition, 2000-

12)

CAN/CSA-C22.2 NO. 60601-1-2-03 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (Adopted IEC 60601-1-2:2001 + A1:2004)

CAN/CSA-C22.2 NO. 60601-1-2A-03 + AMD1:2006

Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests + Amendment 1:2006 to CAN/CSA-C22.2 No. 60601-1-2-03 (Adopted Amendment 1:2004 to IEC 60601-1-2:2001)

Page 4 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA C22.2 NO. 60601-1-2:08 (R2014)

Medical Electrical Equipment part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Adopted IEC 60601-1-2:(07) 3rd edition)

CAN/CSA C22.2 NO. 60601-1-2:16

Medical Electrical Equipment part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and Tests (Adopted IEC 60601-1-2:2014 edition 4.0 2014-02-25)

CAN/CSA-C22.2 NO. 601.1.3-98 (R02)

Medical Electrical Equipment - Part 1: General Requirements for Safety 1- 3. Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment (Adopted IEC 601-1-3:1994, first edition)

CAN/CSA-C22.2 NO. 60601-1-3:09

(R2014)

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment (Adopted IEC

60601-1:2008, second edition, 2008-01)

CAN/CSA-C22.2 NO. 60601-1-3:09

(R2014) + AMD1

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment (Adopted IEC

60601-1:2008, second edition, 2008-01 + A1

CAN/CSA-C22.2 NO. 60601-1-4-02 (R2011)

Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems (Adopted IEC 60601-1-4:1996+A1:1999, edition 1.1, 2000-04)

CAN/CSA-C22.2 NO. 60601-1-6-05 Medical Electrical Equipment - Part 1-6: General Requirements for Safety - Collateral Standard: Usability (Adopted IEC 60601-1-6:2004,

first edition, 2004-06)

CAN/CSA C22.2 NO. 60601-1-6:08 Medical Electrical Equipment part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability (Adopted IEC 60601-1-6 (06) Ed. 2)

CAN/CSA-C22.2 NO. 60601-1-6:11 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (Adopted IEC 60601-1-6:2010, third edition, 2010-01)

CAN/CSA-C22.2 NO. 60601-1-6:11 +

AMD1:2015

Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (Adopted IEC 60601-1-6:2010, third edition, 2010-01 + A1:2013

CAN/CSA-C22.2 NO. 60601-1-8-05

Medical Electrical Equipment - Part 1-8: General Requirements for Safety - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems (Adopted IEC 60601-1-8:2003, first edition,

2003-08)

CAN/CSA C22.2 NO. 60601-1-8:08

Medical Electrical Equipment part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8 (06) Ed.2)

CAN/CSA C22.2 NO. 60601-1-8A:08 + AMD1

Medical Electrical Equipment part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006+A1:2012)

CAN/CSA-C22.2 NO. 60601-1-9:15

Medical electrical equipment – Part 1-9: General requirements for the basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design (Adopted IEC

60601-1-9:2013, edition 1.1, 2013-06)

CAN/CSA-C22.2 NO. 60601-1-10:09 (R2014)

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers (Adopted IEC 60601-1-10:2007, first edition, 2007-11)

CAN/CSA-C22.2 NO. 60601-1-10A:09 + AMD1

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard:

Page 5 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

Requirements for the development of physiologic closed-loop controllers (Adopted IEC 60601-1-10:2007+A1:2013)

CAN/CSA-C22.2 NO. 60601-1-11:11

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Adopted IEC

60601-1-11:2010, first edition, 2010-04)

CAN/CSA-C22.2 NO. 60601-1-11:15

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Adopted IEC

60601-1-11:, second edition)

CAN/CSA-C22.2 NO. 60601-1-12:15

Medical electrical equipment – Part 1-12: General requirements for the basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment (Adopted IEC 60601-1-12:14 edition 1.0, 2014-06)

CAN/CSA-C22.2 NO. 60601-2-1-01 (R05)

Medical Electrical Equipment - Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV (Adopted IEC 60601-2-1:1998, second edition, 1998-06)

CAN/CSA-C22.2 NO. 60601-2-1A-01 (R07)

Amendment 1:2003 to CAN/CSA-C22.2 NO. 60601-2-1-01, Medical Electrical Equipment - Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV (Adopted Amendment 1:2002 to IEC 60601-2-1:1998)

CAN/CSA-C22.2 NO. 60601-2-1:11

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV (Adopted IEC 60601-2-1:2009, third

edition, 2009-10)

CAN/CSA-C22.2 NO. 60601-2-1A:11 + AMD1:2015

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV (Adopted IEC 60601-2-1:2009, third

edition, 2009-10 + A1:2014).

CAN/CSA-C22.2 NO. 60601-2-2-01 Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment (Adopted IEC 60601-

2-2:1998 third edition)

CAN/CSA-C22.2 NO. 60601-2-2:08 Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment (Adopted IEC 60601-

2-2:2006,fourth edition, 2006-07)

CAN/CSA-C22.2 NO. 60601-2-2:09 (R2014)

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (Adopted

IEC 60601-2-2:2009, fifth edition, 2009-02)

CAN/CSA-C22.2 NO. 60601-2-2:19

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (Adopted

IEC 60601-2-2, edition 6.0, 2017-03)

CAN/CSA-C22.2 NO. 601.2.3-92 (R01)

Medical Electrical Equipment - Part 2-3: Particular Requirements for the Safety of Short-Wave Therapy Equipment (Adopted IEC 601- 2-

3:1991)

CAN/CSA-C22.2 NO. 601.2.3A-92 (R01)

Amendment 1:2001 to CAN/CSA-C22.2 NO. 601.2.3-92, Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Short-Wave Therapy Equipment (Adopted Amendment 1:1998 to IEC

601-2-3:1991)

CAN/CSA-C22.2 NO. 60601-2-3:14 Medical electrical equipment – Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment (Adopted ISO 60601-2-3:2012, third edition, 2012-04)

CAN/CSA-C22.2 NO. 60601-2-3:14 +

AMD1:2019

Medical electrical equipment – Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment (Adopted ISO 60601-2-3:2012, third edition, 2012-04 +


Page 6 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 60601-2-4-04 (R09)

Medical Electrical Equipment - Part 2-4: Particular Requirements for the Safety of Cardiac Defibrillators (Adopted IEC 60601-2-4:2005,

second edition, 2002-08)

CAN/CSA-C22.2 NO. 60601-2-4:12 Medical electrical equipment – Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

(Adopted IEC 60601-2-4:2010, third edition, 2010-12)

CAN/CSA-C22.2 NO. 60601-2-5-02 Medical Electrical Equipment - Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment (Adopted IEC

60601-2-5:2005, second edition, 2000-07)

CAN/CSA-C22.2 NO. 60601-2-5:11

Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment (Adopted IEC 60601-2-5:2009, third edition,

2009-07)

CAN/CSA-C22.2 NO. 601.2.6-92 (R05)

Medical Electrical Equipment - Part 2-6: Particular Requirements for the Safety of Microwave Therapy Equipment (Adopted IEC 601-2-

6:1984)

CAN/CSA-C22.2 NO. 60601-2-6:14 Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment (Adopted ISO 60601-2-6:2012, second edition, 2012-04)

CAN/CSA-C22.2 NO. 60601-2-6:14 +

AMD1:2018

Medical electrical equipment – Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment (Adopted ISO 60601-2-6:2012, second edition, 2012-04 +


CAN/CSA-C22.2 NO. 60601-2-7-01 (R2009)

Medical Electrical Equipment - Part 2-7: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-Ray Generators (Adopted IEC 60601-2-7:1998, second edition, 1998-02)

CAN/CSA-C22.2 NO. 60601-2-8-01 Medical Electrical Equipment - Part 2-8: Particular Requirements for the Safety of Therapeutic X-Ray Equipment Operating in the Range 10kV to 1MV (Adopted IEC 60601-2-8:1987+A1:1997, edition 1.1, 1999-04)

CAN/CSA-C22.2 NO. 60601-2-8:12

Medical electrical equipment – Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (Adopted IEC 60601-

2-8:2010, second edition, 2010-11)

CAN/CSA-C22.2 NO. 60601-2-8:12 +

AMD1:2017

Medical electrical equipment – Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (Adopted IEC 60601-

2-8:2010, second edition, 2010-11 + A1:2015-09)

CAN/CSA-C22.2 NO. 60601-2-9-01 (R05)

Medical Electrical Equipment - Part 2-9: Particular Requirements for the Safety of Patient Contact Dosimeters Used in Radiotherapy with Electrically Connected Radiation Detectors (Adopted CEI/IEC 601-2-9:1996, second edition, 1996-10)

CAN/CSA-C22.2 NO. 601.2.10-92 (R05)

Medical Electrical Equipment - Part 2-10: Particular Requirements for the Safety of Nerve and Muscle Stimulators (Adopted IEC 601- 2-

10:1987)

CAN/CSA-C22.2 NO. 601.2.10A-92 (R05)

Amendment 1:2004 to CAN/CSA-C22.2 No. 601.2.10-92, Medical Electrical Equipment - Part 2-10: Particular Requirements for the Safety of Nerve and Muscle Stimulators (Adopted Amendment 1:2001

and Corrigendum 1:2002 to IEC 601-2-10:1987)

CAN/CSA-C22.2 NO. 60601-2-10:14 Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (Adopted ISO 60601-2-10:2012, second edition, 2012-06)

CAN/CSA-C22.2 NO. 60601-2-10:14

+AMD1:2018

Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (Adopted ISO 60601-2-10:2012, second edition, 2012-06+

amendment 1: 2016-04 )

CAN/CSA-C22.2 NO. 60601-2-11-01 (R05)

Medical Electrical Equipment - Part 2-11: Particular Requirements for the Safety of Gamma Beam Therapy Equipment (Adopted IEC 60601-

2-11:1997, second edition, 1997-08)

Page 7 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 60601-2-11A-01

Amendment 1:2005 to CAN/CSA-C22.2 No. 60601-2-11-01, Medical Electrical Equipment - Part 2-11: Particular Requirements for the Safety of Gamma Beam Therapy Equipment (Adopted Amendment

1:2004 to IEC 60601-2-11:1997)

CAN/CSA-C22.2 NO. 60601-2-11:15 Medical Electrical Equipment – Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment (Adopted IEC 60601-2-11, third edition, 2013-01)

CAN/CSA-C22.2 NO. 60601-2-12-03 (R07)

Medical Electrical Equipment - Part 2-12: Particular Requirements for the Safety of Lung Ventilators - Critical Care Ventilators (Adopted IEC 60601-2-12:03, second edition, 2001-10)

CAN/CSA-C22.2 NO. 80601-2-12:12

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (Adopted ISO 80601-2-12-:2011, first edition, 2011-04-15, with Canadian deviations, including adopted technical corrigendum 1:2011 to ISO 80601-2-12:2011)

CAN/CSA-C22.2 NO. 60601-2-13-07

Medical Electrical Equipment - Part 2-13: Particular Requirements for the Safety and Essential Performance of Anaesthetic Systems (Adopted IEC 60601-2-13:2003, third edition, 2003-05, including Amendment 1:2006, with Canadian deviations)

CAN/CSA-C22.2 NO. 80601-2-13:15

Medical electrical equipment – Part 2-13: Particular requirements for the basic safety and essential performance of anaesthetic workstation (Adopted ISO 80601-2-13:2011, first edition, 2011-08 +

Amendment 1: 2015-03-01)

CAN/CSA-C22.2 NO. 60601-2-16-01 (R05)

Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment (Adopted IEC 60601-2-16:1998, second edition, 1998-02)

CAN/CSA-C22.2 NO. 60601-2-16:09

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Adopted IEC 60601-1-2008, third edition, 2008-04)

CAN/CSA-C22.2 NO. 60601-2-16:14

Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Adopted IEC 60601-

2-16:2010, Fourth edition, 2012-03)

CAN/CSA-C22.2 NO. 60601-2-17-04 (R09)

Medical Electrical Equipment - Part 2-17: Particular Requirements for the Safety of Automatically-Controlled Brachytherapy Afterloading Equipment (Adopted CEI/IEC 60601-2-17:2005, second edition, 2004-01)

CAN/CSA-C22.2 NO. 60601-2-17:15

Medical electrical equipment - Part 2-17: Particular Requirements for the basic safety and essential of Automatically-Controlled Brachytherapy After loading Equipment (Adopted CEI/IEC 60601-2-

17:2013, third edition, 2013-11)

CAN/CSA-C22.2 NO. 60601-2-18-01 (R05)

Medical Electrical Equipment - Part 2-18: Particular Requirements for the Safety of Endoscopic Equipment (Adopted CEI/IEC 601-2-18:1996, second edition, 1996-08)

CAN/CSA-C22.2 NO. 60601-2-18A-01 (R05)

Amendment 1:2002 to CAN/CSA-C22.2 NO. 60601-2-18-01, Medical Electrical Equipment - Part 2-18: Particular Requirements for the Safety of Endoscopic Equipment (Adopted Amendment 1:2000 to

CEI/IEC 601-2-18:1996)

CAN/CSA-C22.2 NO. 60601-2-18:11 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (Adopted IEC 60601-2-18:2009, third edition, 2009-08)

CAN/CSA-C22.2 NO. 601.2.19-92 (R01)

Amendment 1:2001 to CAN/CSA-C22.2 NO. 601.2.19-92, Medical Electrical Equipment - Part 2: Particular Requirements for Safety of Baby Incubators (Adopted Amendment 1:1996 to IEC 601-2-19:1990)

CAN/CSA-C22.2 NO. 601.2.19A-92 (R01)

Amendment 1:2001 to CAN/CSA-C22.2 NO. 601.2.19-92, Medical Electrical Equipment - Part 2-19: Particular Requirements for Safety of Baby Incubators (Adopted Amendment 1:1996 to IEC 601-2-19:1990)

CAN/CSA-C22.2 NO. 60601-2-19:09 (R2014)

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Adopted IEC 60601-2-19:2009, second edition, 2009-02)

Page 8 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 60601-2-19:09 TC1

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Adopted IEC 60601-2-19:2009, second edition, 2009-02 + technical corrigendum TC1: February 2012)

CAN/CSA-C22.2 NO. 60601-2-19:09 (R2014)+AMD1:2018

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Adopted IEC 60601-2-19:2009, second edition, 2009-02 +amendment 1:2016-04 )

CAN/CSA-C22.2 NO. 601.2.20-92 (R01)

Medical Electrical Equipment - Part 2-20: Particular Requirements for the Safety of Transport Incubators (Adopted IEC 601-2-20:1990)

CAN/CSA-C22.2 NO. 601.2.20A-92 (R01)

Amendment 1:2001 to CAN/CSA-C22.2 NO. 601.2.20-92, Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Transport Incubators (Adopted Amendment 1:1996 to IEC 601-2-

20:1990)

CAN/CSA-C22.2 NO. 60601-2-20:10 (2014)

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (Adopted IEC 60601-2-20:2009, second edition, 2009-02)

CAN/CSA-C22.2 NO. 60601-2-20:10 TC1


technical corrigendum TC1: October 2012)

CAN/CSA-C22.2 NO. 60601-2-20:10 + AMD1:2019



CAN/CSA-C22.2 NO. 601.2.21-98 (R02)

Medical Electrical Equipment – Part 2-21: Particular Requirements for the Safety of Infant Radiant Warmers (Adopted IEC 601-2-21:1994,

first edition)

CAN/CSA-C22.2 NO. 601.2.21A-98

Amendment 1:2001 to CAN/CSA-C22.2 NO. 601.2.21-98, Medical Electrical Equipment - Part 2-21: Particular Requirements for the Safety of Infant Radiant Warmers (Adopted Amendment 1:1996 to IEC

601-2-21:1994)

CAN/CSA-C22.2 NO. 60601-2-21:10 (R2014)

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (Adopted IEC 60601-2-21:2009, second edition, 2009-02)

CAN/CSA-C22.2 NO. 60601-2-21:10 (R2014) + AMD1:2018

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (Adopted IEC 60601-2-21:2009, second edition, 2009-02 + amendment 1: 2016-04)

CAN/CSA-C22.2 NO. 60601-2-22-01 (R05)

Medical Electrical Equipment - Part 2-22: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment (Adopted CEI/IEC 601-2-22:1995, second edition, 1995-11)

CAN/CSA-C22.2 NO. 60601-2-22:08 (R2014)

Medical Electrical Equipment part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (Adopted IEC 60601-2-22 (07) Ed. 3)

CAN/CSA-C22.2 NO. 60601-2-22A:08 + AMD1:2014

Medical Electrical Equipment part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (Adopted IEC 60601-2-

22:2007+A1:2012).

CAN/CSA-C22.2 NO. 60601-2-23-02

Medical Electrical Equipment - Part 2-23: Particular Requirements for the Safety, Including Essential Performance, of Transcutaneous Partial Pressure Monitoring Equipment (Adopted IEC 60601-2-23:1999, second edition, 1999-12)

CAN/CSA-C22.2 NO. 60601-2-23:12

Medical electrical equipment – Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment (Adopted IEC 60601-2-23:2011, third

edition, 2011-02)

Page 9 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 60601-2-24-01 (R2009)

Medical Electrical Equipment - Part 2-24: Particular Requirements for the Safety of Infusion Pumps and Controllers (Adopted IEC 60601-2-

24:1998, first edition, 1998-02)

CAN/CSA-C22.2 NO. 60601-2-24:15 Medical electrical equipment - Part 2-24: Particular Requirements for the basic safety and essential performance of Infusion Pumps and Controllers (Adopted IEC 60601-2-24:2012, second edition, 2012-10)

CAN/CSA-C22.2 NO. 601.2.25-94 (R07)

Medical Electrical Equipment - Part 2-25: Particular Requirements for the Safety of Electrocardiographs (Adopted IEC 601-2-25:1993 with

modifications)

CAN/CSA-C22.2 NO. 601.2.25A-94

Amendment 1:2002 to CAN/CSA-C22.2 No. 601.2.25-94, Medical Electrical Equipment - Part 2-25: Particular Requirements for the Safety of Electrocardiographs (Adopted Amendment 1:1999 to IEC 601-

2-25:1993)

CAN/CSA-C22.2 NO. 60601-2-25:12 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (Adopted IEC 60601-2-25:2010, Edition 2.0, 2011-10)

CAN/CSA-C22.2 NO. 60601-2-26-04 (R09)

Medical Electrical Equipment - Part 2-26: Particular Requirements for the Safety of Electroencephalographs (Adopted IEC 60601-2-26:2003,


CAN/CSA-C22.2 NO. 60601-2-26:14

Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Adopted IEC 60601-2-26:2012, Edition 3.0,

2012-05)

CAN/CSA-C22.2 NO. 60601-2-27-06

Medical Electrical Equipment - Part 2-27: Particular Requirements for the Safety, Including Essential Performance, of Electrocardiographic Monitoring Equipment (Adopted IEC 60601-2-27:2005, second edition,

2005-08)

CAN/CSA-C22.2 NO. 60601-2-27:11

Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (Adopted IEC 60601-2-27:2011, third edition, 2011-

03)

CAN/CSA-C22.2 NO. 60601-2-27:11

TC1

Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (Adopted IEC 60601-2-27:2011, third edition, 2011-

03 + technical corrigendum TC1: October 2012)

CAN/CSA-C22.2 NO. 601.2.28-94 (R07)

Medical Electrical Equipment - Part 2-28: Particular Requirements for the Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis (Adopted IEC 601-2-28:1993 with modifications)

CAN/CSA-C22.2 NO. 60601-2-28:12

Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Adopted IEC 60601-2-28:2010, second edition,

2010-02)

CAN/CSA-C22.2 NO. 60601-2-28:18

Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Adopted IEC 60601-2-28:2010, third edition, 2017-

06)

CAN/CSA-C22.2 NO. 60601-2-29-02 (R07)

Medical Electrical Equipment - Part 2-29: Particular Requirements for the Safety of Radiotherapy Simulators (Adopted CEI/IEC 60601-2-

29:1999, second edition, 1999-01)

CAN/CSA-C22.2 NO. 60601-2-29:10 (R2014)

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (Adopted IEC 60601-2-29:2008, third edition, 2008-06)

CAN/CSA-C22.2 NO. 60601-2-30-02 (R06)

Medical Electrical Equipment - Part 2-30: Particular Requirements for the Safety, Including Essential Performance, of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment (Adopted IEC

60601-2-30:1999, second edition, 1999-12)

CAN/CSA-C22.2 NO. 80601-2-30:10

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Adopted IEC 80601-2-30:2009, first

edition, 2009-01)

Page 10 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 80601-2-30:10


Technical Corrigendum 1:2011 to CAN/CSA-C22.2 No. 80601-2-30-10, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Adopted IEC 80601-2-30:2009, first

edition, 2009-01)

CAN/CSA-C22.2 NO. 80601-2-30A:10 + AMD1:2015

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Adopted IEC 80601-2-30:2009, first

edition, 2009-01 + A1: 2013).

CAN/CSA-C22.2 NO. 601.2.31-98 (R02)

Medical Electrical Equipment - Part 2-31: Particular Requirements for the Safety of External Cardiac Pacemakers With Internal Power Source (Adopted IEC 601-2-31:1994)

CAN/CSA-C22.2 NO. 601.2.31A-98

Amendment 1:2001 to CAN/CSA-C22.2 NO. 601.2.31-98, Medical Electrical Equipment - Part 2-31: Particular Requirements for the Safety of External Cardiac Pacemakers with Internal Power Source (Adopted Amendment 1:1998 to IEC 601-2-31:1994)

CAN/CSA-C22.2 NO. 60601-2-31:09 (2014)

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (Adopted IEC 60601-2-31:2008,


CAN/CSA-C22.2 NO. 60601-2-31A:09 + AMD1:2014

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (Adopted IEC 60601-2-

31:2008+A1:2011).

CAN/CSA-C22.2 NO. 601.2.32-98 (R02)

Medical Electrical Equipment - Part 2-32: Particular Requirements for the Safety of Associated Equipment of X-Ray Equipment (Adopted

IEC 601-2-32:1994)

CAN/CSA-C22.2 NO. 60601-2-33-04 (R09)

Medical Electrical Equipment - Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis (Adopted IEC 60601-2-33:2002 + A1:2005, edition 2.1, 2006-02)

CAN/CSA-C22.2 NO. 60601-2-33B-04 (R09)

Amendment 2:2010 to CAN/CSA-C22.2 NO. 60601-2-33-04, Medical Electrical Equipment - Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis (Adopted Amendment 2:2007 to IEC 60601-2-33:2002)

CAN/CSA-C22.2 NO. 60601-2-33:12

Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (Adopted IEC 60601-2-33:2010, third

edition, 2010-03)

CAN/CSA-C22.2 NO. 60601-2-33:12

TC1


edition, 2010-03 + technical corrigendum TC1: October 2012)

CAN/CSA-C22.2 NO. 60601-2-33:12 +

AMD1:2013


edition, 2010-03 + A1:2013– edition 3.1 This consolidated version consists of the third edition (2010) and its amendment 1 (2013-04)).

CAN/CSA-C22.2 NO. 60601-2-33B:12

+ AMD1:2013 + AMD2:2017


edition, 2010-03 + A1:2013 + A2: 2015)

CAN/CSA-C22.2 NO. 60601-2-34-02 (R06)

Medical Electrical Equipment - Part 2-34: Particular Requirements for the Safety, Including Essential Performance, of Invasive Blood Pressure Monitoring Equipment (Adopted IEC 60601-2-34:2005, second

edition, 2000-10)

CAN/CSA-C22.2 No. 60601-2-34:12

Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (Adopted IEC 60601-2-34:2011, Edition

3.0, 2011-05)

Page 11 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 80601-2-35:12

Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

(Adopted IEC 80601-2-35:2009, second edition, 2009-10)

CAN/CSA-C22.2 NO. 80601-2-35:12

TC 1

Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

(Adopted IEC 80601-2-35:2009, second edition, 2009-10 + technical corrigendum TC1: October 2012)

CAN/CSA-C22.2 NO. 60601-2-36-98 (R2012)

Medical Electrical Equipment - Part 2-36: Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy (Adopted IEC 601-2-36:1997)

CAN/CSA-C22.2 NO. 60601-2-36:16 Medical Electrical Equipment - Part 2-36: Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy (Adopted IEC 60601-2-36:2014, second edition, 2014-04)

CAN/CSA-C22.2 NO. 60601-2-37A-03

Amendment 1:2005 to CAN/CSA-C22.2 No. 60601-2-37-03, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment (Adopted Amendment 1:2004 to IEC 60601-2-37:2001)

CAN/CSA-C22.2 NO. 60601-2-37:03 (R07)

Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment (Adopted IEC 60601-2-37:2001, first edition, 2001-07)

CAN/CSA C22.2 NO. 60601-2-37:08 (R2014)

Medical Electrical Equipment part 2-37: Particular requirements for the basic safety and performance of ultrasonic medical diagnostic and monitoring equipment, (Adopted IEC 60601-2-37(07) Ed 2.0)

CAN/CSA-C22.2 NO. 60601-2-38-03 (R07)

Medical Electrical Equipment - Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital Beds (Adopted CEI/IEC

601-2-38:1996, first edition, 1996-10, including Amendment 1:1999)

CAN/CSA-C22.2 NO. 60601-2-39-02 (R07)

Medical Electrical Equipment - Part 2-39: Particular Requirements for the Safety of Peritoneal Dialysis Equipment (Adopted IEC 60601-2-

39:2003, first edition, 1999-06)

CAN/CSA-C22.2 NO. 60601-2-39:09 (R2014)

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (Adopted IEC 60601-2-39:2007, second edition, 2007-11)

CAN/CSA-C22.2 NO. 60601-2-40-01 (R05)

Medical Electrical Equipment - Part 2-40: Particular Requirements for the Safety of Electromyographs and Evoked Response Equipment (Adopted IEC 60601-2-40:1998, first edition, 1998-02)

CAN/CSA-C22.2 NO. 60601-2-40:17

Medical electrical equipment – Part 2-40: Particular requirements for the basic safety and essential performance of electromyography and evoked response equipment (Adopted IEC 60601-2-40, edition 2.0,

2016-08)

CAN/CSA-C22.2 NO. 60601-2-41-02 (R07)

Medical Electrical Equipment - Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis (Adopted IEC 60601-2-41:2000, first edition, 2000-02)

CAN/CSA-C22.2 NO. 60601-2-41:11

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (Adopted IEC 60601-2-41:2009, second edition,

2009-08)

CAN/CSA-C22.2 NO. 60601-2-41:11 + AMD1

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (Adopted IEC 60601-2-41:2009, second edition +

A1:21013 – edition 2.1 This consolidated version consists of the third edition (2010) and its amendment 1 (2013-10)).

CAN/CSA-C22.2 NO. 60601-2-43-03 (R07)

Medical Electrical Equipment - Part 2-43: Particular Requirements for the Safety of X-Ray Equipment for Interventional Procedures (Adopted IEC 60601-2-43:2000, first edition, 2000-06)

CAN/CSA-C22.2 NO. 60601-2-43:11


2010-03)

Page 12 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 60601-2-43:11 +

AMD1:2019


2010-03 + amendment 1, 2017-08)

CAN/CSA-C22.2 NO. 60601-2-44-03 (R07)

Medical Electrical Equipment - Part 2-44: Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography (Adopted IEC 60601-2-44:2001, second edition, 2001-06)

CAN/CSA-C22.2 NO. 60601-2-44A-04

Amendment 1:2004 to CAN/CSA-C22.2 No. 60601-2-44-03, Medical Electrical Equipment - Part 2-44: Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography (Adopted

Amendment 1:2002 to IEC 60601-2-44:2001)

CAN/CSA-C22.2 NO. 60601-2-44:10

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted IEC 60601-2-44:2009, third edition,

2009-02)

CAN/CSA-C22.2 NO. 60601-2-44:10


Technical Corrigendum 1:2011 to CAN/CSA-C22.2 NO. 60601-2-44-10, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted IEC 60601-2-44:2009, third edition,

2009-02)

CAN/CSA-C22.2 NO. 60601-2-44:10 + AMD1

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted IEC 60601-2-44:2009+A1:2012 - edition

3.1 This consolidated version consists of the third edition (2009) and its amendment 1 (2012)).

CAN/CSA-C22.2 NO. 60601-2-44:10 + AMD2:2018


3.2 This consolidated version consists of the third edition (2009) and its amendment 2 (2016-03)).

CAN/CSA-C22.2 NO. 60601-2-45-02 (R07)

Medical Electrical Equipment - Part 2-45: Particular Requirements for the Safety of Mammographic X-Ray Equipment and Mammographic Stereotactic Devices (Adopted CEI/IEC 60601-2-45:2006, second edition,

2001-05)

CAN/CSA-C22.2 NO. 60601-2-45:11

Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (Adopted IEC

60601-2-45:2011, third edition, 2011-02)

CAN/CSA-C22.2 NO. 60601-2-45:11 +

AMD1:2017


60601-2-45:2011, third edition, 2011-02 +A1:2015)

CAN/CSA-C22.2 NO. 60601-2-46-01 (R05)

Medical Electrical Equipment - Part 2-46: Particular Requirements for the Safety of Operating Tables (Adopted IEC 60601-2-46:1998, first

edition, 1998-06)

CAN/CSA-C22.2 NO. 60601-2-46:12 Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (Adopted IEC 60601-2-46:2010, second edition, 2010-12)

CAN/CSA-C22.2 NO. 60601-2-46:18 Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables (Adopted IEC 60601-2-46, third edition, 2016-08)

CAN/CSA-C22.2 NO. 60601-2-47-03

Medical Electrical Equipment - Part 2-47: Particular Requirements for the Safety, Including Essential Performance, of Ambulatory Electrocardiographic Systems (Adopted IEC 60601-2-47:2006, first

edition, 2001-07)

CAN/CSA-C22.2 NO. 60601-2-47:14

Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems (Adopted IEC 60601-2-47:2012, Edition

2.0, 2012-02)

Page 13 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 60601-2-49-04 (R09)

Medical Electrical Equipment - Part 2-49: Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment (Adopted IEC 60601-2-49:2006, first edition, 2001-07)

CAN/CSA-C22.2 NO. 60601-2-49:11

Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment (Adopted IEC 60601-2-49:2011, second edition,

2011-02)

CAN/CSA-C22.2 NO. 60601-2-50-03 (R07)

Medical Electrical Equipment - Part 2-50: Particular Requirements for the Safety of Infant Phototherapy Equipment (Adopted IEC 60601-2-

50:2005, first edition, 2000-07)

CAN/CSA-C22.2 NO. 60601-2-50:10 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (Adopted IEC 60601-2-50:2009, second edition, 2009-03)

CAN/CSA-C22.2 NO. 60601-2-50:10


Technical Corrigendum 1:2011 to CAN/CSA-C22.2 No. 60601-2-50-10, Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (Adopted IEC 60601-2-50:2009, second edition, 2009-03)

CAN/CSA-C22.2 NO. 60601-2-50:10 + TC1:2011 + AMD1:2018

Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (Adopted IEC 60601-2-50:2009, second edition, 2009-03 +


CAN/CSA-C22.2 NO. 60601-2-51-04 (R09)

Medical Electrical Equipment - Part 2-51: Particular Requirements for Safety, Including Essential Performance, of Recording and Analyzing Single Channel and Multichannel Electrocardiographs (Adopted

CEI/IEC 60601-2-51:2005, first edition, 2003-02)

CAN/CSA-C22.2 NO. 60601-2-52:11 Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds (Adopted

IEC 60601-2-52:2009, first edition, 2009-12)

CAN/CSA-C22.2 NO. 60601-2-52:11 + AMD1:2017

Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds (Adopted IEC 60601-2-52:2009, first edition, 2009-12+ A1:2015)

CAN/CSA-C22.2 NO. 60601-2-54:11

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Adopted IEC 60601-2-54:2009, first edition,

2009-06)

CAN/CSA-C22.2 NO. 60601-2-54:11 + Update No. 1

Update No 1 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Adopted IEC 60601-2-

54:2009, first edition, 2009-06)

CAN/CSA-C22.2 NO. 60601-2-54:11 + Update No. 1 + AMD1:2017

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Adopted IEC 60601-2-54:2009, first edition

2009-06+ A1:2015)

CAN/CSA-C22.2 NO. 80601-2-55:14 Medical electrical equipment – Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (Adopted ISO 80601-2-55:2011, first edition, 2011-12)

CAN/CSA-C22.2 NO. 80601-2-56:12

Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (Adopted ISO 80601-2-56, first edition,

2013-02)

CAN/CSA-C22.2 NO. 60601-2-57:11

Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (Adopted IEC 60601-2-57:2011, first edition, 2011-

01)

CAN/CSA-C22.2 NO. 80601-2-58:10


58:2008, first edition, 2008-10)

Page 14 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 80601-2-58:15


58:14, second edition, 2014-09)

CAN/CSA-C22.2 NO. 80601-2-58:15 + AMD1:2019


58:14, second edition, 2014-09 + amendment 1, 2016-10)

CAN/CSA-C22.2 NO. 80601-2-59:10

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Adopted IEC

80601-2-59:2008, first edition, 2008-10)

CAN/CSA-C22.2 NO. 80601-2-59:10


Technical Corrigendum 1:2011 to CAN/CSA-C22.2 No. 80601-2-59-10, Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Adopted IEC

80601-2-59:2008, first edition, 2008-10)

CAN/CSA-C22.2 NO. 80601-2-60:14 Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (Adopted IEC 80601-2-60:2012, first edition, 2012-02)

CAN/CSA-C22.2 NO. 80601-2-61:14 Medical electrical equipment – Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment (Adopted ISO 80601-2-61:2011, first edition, 2011-04)

CAN/CSA-C22.2 NO. 60601-2-62:15

Medical electrical equipment – Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment. (Adopted IEC 60601-2-

62:2013, first edition, 2013-07)

CAN/CSA-C22.2 NO. 60601-2-63:15 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (Adopted IEC 60601-2-63:2012, first edition, 2012-09-19)

CAN/CSA-C22.2 NO. 60601-2-63:15 +

AMD1:2019

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (Adopted IEC 60601-2-63:2012, first edition, 2012-09-19 +


CAN/CSA-C22.2 NO. 60601-2-64:15 Medical electrical equipment – Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam ME

Equipment (Adopted IEC 60601-2-64:2014 , first edition, 2014-09)

CAN/CSA-C22.2 NO. 60601-2-65:15 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (Adopted IEC 60601-2-65:2012, first edition,2012-09)

CAN/CSA-C22.2 NO. 60601-2-66:15

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems (Adopted IEC 60601-2-66:2012, first

edition, 2012-10)

CAN/CSA-C22.2 NO. 60601-2-65:15 +

AMD1:2019

Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (Adopted IEC 60601-2-65:2012, first edition,2012-09 +


CAN/CSA-C22.2 NO. 80601-2-67:17 Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (Adopted ISO 80601-2-7:2014, first edition)

CAN/CSA-C22.2 NO. 60601-2-68:15

Medical electrical equipment - Part 2-68: Particular requirements for basic safety and essential performance of X-ray based image guided radiotherapy equipment for use with electron accelerators, light ion beam therapy systems and radionuclide beam therapy systems (Adopted IEC 60601-2-68:2014, first edition 2014-09)

CAN/CSA-C22.2 NO. 80601-2-69:16 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (Adopted ISO 80601-2-69:2014, first edition 2014-05)

Page 15 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

CAN/CSA-C22.2 NO. 80601-2-70:17 Medical electrical equipment – Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition)

CAN/CSA-C22.2 NO. 80601-2-71:17 Medical electrical equipment – Part 2-71: Particular requirements for the basic safety and essential performance of functional oximeter equipment (Adopted ISO 80601-2-71:2015, first edition)

CAN/CSA-C22.2 NO. 80601-2-72:17

Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted

ISO 80601-2-72:2015, first edition)

CAN/CSA-C22.2 NO. 80601-2-74:19 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (Adopted ISO 80601-2-74:2017, first edition, 2017-05)

CAN/CSA-C22.2 NO. 62304:14 Medical devices software – Software life cycle processes (Adopted

IEC 62304 edition 1.0, 2006-05) CAN/CSA-C22.2 NO. 62304:14 +

AMD1:2018 Medical devices software – Software life cycle processes (Adopted

IEC 62304 edition 1.0, 2006-05 + Amendment1:2015-06)

CAN/CSA-C22.2 NO. 62366:14 Medical devices- Application of usability engineering to medical devices (Adopted IEC 62366 edition 1.0, 2007-10)

CAN/CSA-IEC 62366-1:15 Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, first edition, 2015-02)

CAN/CSA-ISO 10079-1:16 Medical suction equipment — Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition 2015)

CAN/CSA-ISO 16571:16 Systems for evacuation of plume generated by medical device (Adopted ISO 16571:2014, first edition 2014)

CAN/CSA-Z10535-03 Hoists for the Transfer of Disabled Persons - Requirements and Test Methods (Adopted ISO 10535:1998, first edition, 1998-10-15, with

Canadian deviations)

CAN/CSA-Z10535:15 Hoists for the Transfer of Disabled Persons - Requirements and Test Methods (Adopted ISO 10535:1998, second edition, 1998-10-15, with

Canadian deviations)

CAN/CSA-C22.2 NO. 205-17 Signal Equipment* (To be used in conjunction with the CAN/CSA-C22.2 NO.

60601-1 standard for HealthCare Nurse Call Equipment)

Note: Highlighted in green 3rd edition standards

ATTACHMENT 4

List of standards accepted/recognized in the United States of America

Standard Title

IEC 60601-1:2005 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance

ANSI/AAMI ES60601-1:2005 (R2012) (IEC 60601-1:2005, MOD)

Medical electrical equipment, Part 1: General requirements for basic safety and essential performance

ANSI/AAMI ES60601-1:2005/C1:2009 (R2012) AND A2 (R2012) (COORIGENDUM 1)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Corrigendum 1

ANSI/AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND A2:2010(R)2012 (CONSOLIDATED TEXT)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005+A1:2012, MOD).

UL 60601-1 Medical Electrical Equipment part 1: General requirements for Safety adopted IEC 601-1 2nd edition (90) + am1 and am2

IEC 60601-1-1:2000 Medical electrical equipment, Part 1: General requirements for safety-1. Collateral standard: Safety requirements for medical electrical systems

Page 16 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

ANSI/AAMI/IEC 60601-1-2:2001

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Includes amendment 1)

ANSI/AAMI/IEC 60601-1-2:2007 (R2012)

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

ANSI/AAM/IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

IEC 60601-1-3:2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-1-3:2008 +AMD1:2013 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-1-4:1996/(R)2005 Medical electrical equipment, Part 1: General requirements for safety. 4. Collateral standard: Programmable electrical medical systems

IEC 60601-1-4:1996/A1:1999/(R)2002 Amendment to IEC 60601-1-4:1996, Medical electrical equipment, Part 1: General requirements for safety - 4: Collateral standard: Programmable electrical medical systems

IEC 60601-1-6:2006 Medical electrical equipment, Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-6:2006 + AMD1:2013 Medical electrical equipment, Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-8:2006

Medical electrical equipment, Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

ANSI/AAMI/IEC 60601-1-8:2006 + AMD1:2012

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

IEC 60601-1-9:2007

Medical electrical equipment, Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the reduction of environmental impacts

IEC 60601-1-9 AMD1 Ed1.0b:2013

Medical electrical equipment, Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the reduction of environmental impacts

IEC 60601-1-10:2007

Medical electrical equipment, Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Process requirements for the development of physiologic closed-loop controllers

IEC 60601-1-10:2007 + AMD1:2013

Medical electrical equipment, Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Process requirements for the development of physiologic closed-loop controllers

ANSI/AAMI HA60601-1-11:2011

Medical Electrical Equipment – Part1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical equipment and medical electrical systems used in home healthcare environment

ANSI/AAMI/IEC HA60601-1-11:2015

Medical Electrical Equipment – Part1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical equipment and medical electrical systems used in home healthcare environment

http://webstore.ansi.org/RecordDetail.aspx?sku=ANSI%2fAAMI+HA60601-1-11%3a2011


Page 17 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

ANSI/AAMI/IEC 60601-1-12:2016

Medical electrical equipment – Part 1-12: General requirements for the basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment

IEC 60601-2-1:2002

Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV (including amendment 1)

IEC 60601-2-1:2002 + AMD1:2014

Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV (including amendment 1)

IEC 60601-2-2:2006 Medical electrical equipment, Part 2-2: Particular requirements for the safety of high frequency surgical equipment

IEC 60601-2-2:2009

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-2:2017

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

ANSI/AAMI/IEC 60601-2-2:2006 Medical electrical equipment, Part 2-2: Particular requirements for the safety of high frequency surgical equipment

ANSI/AAMI/IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories

ANSI/AAMI/IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories

IEC 60601-2-3:1991/(R)2002 Medical electrical equipment, Part 2-3: Particular requirements for the safety of short-wave therapy equipment

IEC 60601-2-3:1998 Amendment 1 - Medical electrical equipment, Part 2-3: Particular requirements for the safety of short-wave therapy equipment (including amendment 1)

IEC 60601-2-4:2002 Medical electrical equipment, Part 2-4: Particular requirements for the safety of cardiac defibrillators

IEC 60601-2-4:2002 + AMD1:2018 Medical electrical equipment, Part 2-4: Particular requirements for the safety of cardiac defibrillators

ANSI/AAMI/IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators

IEC 60601-2-5:2000 Medical electrical equipment, Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

IEC 60601-2-6:1984 Medical electrical equipment, Part 2-6: Particular requirements for the safety of microwave therapy equipment

IEC 60601-2-7:1998 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

IEC 60601-2-8:1997 Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (Including amendment 1)

IEC 60601-2-8:2010 + AMD1:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

IEC 60601-2-10:1987 Medical electrical equipment, Part 2-10: Particular requirements for the safety of nerve and muscle stimulators


Page 18 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

IEC 60601-2-10: 2001 Corrigendum 1 to Amendment 1 - Medical electrical equipment. Part 2: Particular requirements for the safety of nerve and muscle stimulators

IEC 60601-2-10:2014 + AMD1:2016 Medical electrical equipment, Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC 60601-2-11:1997 Medical electrical equipment - Part 2: Particular requirements for the safety of gamma beam therapy equipment

IEC 60601-2-11:2004 Amendment 1 - Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

IEC 60601-2-11:2013 Medical electrical equipment – Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

IEC 60601-2-12:2001 Medical electrical equipment, Part 2-12: Particular requirements for the safety of lung ventilators for medical use - Critical care ventilators

ISO 80601-2012:2011 Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

IEC 60601-2-13:2003 Medical electrical equipment, Part 2-13: Particular requirements for the safety of anaesthetic systems

IEC 60601-2-13:2003/A1:2006 Amendment 1 to IEC 60601-2-13:2003, Medical electrical equipment, Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

IEC 60601-2-13:2009 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (including amendment 1)

ISO 80601-2-13:2011 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

ANSI/AAMI/IEC 60601-2-16:2008 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-16:2008 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-16:2008 Corrigendum 1 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

ANSI/AAMI/IEC 60601-2-16:2012 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.

IEC 60601-2-16:2018 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.

IEC 60601-2-17:2004 Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy after loading equipment

IEC 60601-2-17:2013 Medical electrical equipment - Part 2-17: Particular requirements for the safety and essential of automatically-controlled brachytherapy after loading equipment

IEC 60601-2-18:1996 Medical electrical equipment, Part 2-18: Particular requirements for the safety of endoscopic equipment

IEC 60601-2-18:1996/A1:2000 Amendment 1 to IEC 60601-2-18:1996, Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment

IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

IEC 60601-2-19:1990 Medical electrical equipment, Part 2-19: Particular requirements for the safety of baby incubators

Page 19 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

IEC 60601-2-19:2009 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

ANSI/AAMI/IEC 60601-2-19:2009/(R)2014+AMD1:2016

Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

ANSI/AAMI II36:2004 Medical electrical equipment, Part 2: Particular requirements for safety of baby incubators

IEC 60601-2-20:1990 Medical electrical equipment, Part 2-20: Particular requirements for the safety of transport incubators

IEC 60601-2-20:1990/A1:1996 Amendment 1. Medical electrical equipment, Part 2-20: Particular requirements for the safety of transport incubators

IEC 60601-2-20:2009 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

ANSI/AAMI/IEC 60601-2-20:2009 Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

ANSI/AAMI/IEC 60601-2-20:2009(R)2014 + AMD1:2016

Amendment 1 of Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

IEC 60601-2-21:1994 Medical electrical equipment, Part 2-21: Particular requirements for the safety of infant radiant warmers

IEC 60601-2-21:1994/A1:1996 Amendment 1. Medical electrical equipment, Part 2-21: Particular requirements for the safety of infant radiant warmers

IEC 60601-2-21:2009 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

ANSI/AAMI/IEC 60601-2-21:2001 Medical electrical equipment, Part 2-21: Particular requirements for the safety of infant radiant warmers (Includes amendment 1)

ANSI/AAMI/IEC 60601-2-21:2009 Medical electrical equipment, Part 2-21: Particular requirements for the basic safety and essential; performance of infant radiant warmers

ANSI/AAMI/IEC 60601-2-21:2009(R)2014 + AMD1:2016

Amendment 1 of Medical electrical equipment, Part 2-21: Particular requirements for the basic safety and essential; performance of infant radiant warmers

IEC 60601-2-22:2007 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60601-2-22:2007 + AMD:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60601-2-23:1999 Medical electrical equipment, Part 2-23: Particular requirements for the safety of transcutaneous partial pressure monitoring equipment

IEC 60601-2-23:2011 Medical electrical equipment, Part 2-23: Particular requirements for the safety of transcutaneous partial pressure monitoring equipment

IEC 60601-2-24:1998 Medical electrical equipment, Part 2-24: Particular requirements for the safety of infusion pumps and controllers

ANSI/AAMI ID26:2004 Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers

IEC 60601-2-25:1993 Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs

IEC 60601-2-25:1993/A1:1999 Amendment 1 to IEC 60601-2-25:1993, Medical electrical equipment, Part 2: Particular requirements for the safety of electrocardiographs

ANSI/AAMI/IEC 60601-2-25:2011 Medial electrical equipment – Part 2-25: Particuilar requirements for the basic safety and essential performance of electrocardiographs.

IEC 60601-2-26:2002 Medical electrical equipment, Part 2-26: Particular requirements for the safety of electroencephalographs

ANSI/AAMI/IEC 60601-2-27:2011 Medical electrical equipment, Part 2-27: Particular requirements for the basic safety and essential performance, of electrocardiographic monitoring equipment

http://webstore.ansi.org/RecordDetail.aspx?sku=ANSI%2fAAMI%2fIEC+60601-2-25%3a2011

Page 20 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

IEC 60601-2-27:2005 Medical electrical equipment, Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

IEC 60601-2-27:2011 Medical electrical equipment, Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

IEC 60601-2-28:1993 Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

IEC 60601-2-28: 2010 Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC 60601-2-28:2017 Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

IEC 60601-2-30:1999 Medical electrical equipment, Part 2-30: Particular requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

AAMI/ANSI/IEC 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers

AAMI/ANSI/IEC 80601-2-30:2009 & A1:2013

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers and amendment 1

AAMI/ANSI/IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers

IEC 60601-2-31:2008 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

IEC 60601-2-31:2008 + AMD1:2011 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

IEC 60601-2-32:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

IEC 60601-2-33:2006 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

IEC 60601-2-33:2008 Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (including amendment 1 and 2)

IEC 60601-2-33:2010 + AMD1:2013 Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

IEC 60601-2-33:2010 + AMD2:2015 Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

IEC 60601-2-34:2000 Medical electrical equipment, Part 2-34: Particular requirements for the safety of invasive blood pressure monitoring equipment

IEC 60601-2-34:2011 Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

IEC 60601-2-35:1996 Medical electrical equipment, Part 2-35: Particular requirements for the safety of blankets, pads, and mattresses intended for heating in medical use

ANSI/AAMI/ISO 80601-2-35:2009 Medical electrical equipment-Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

Page 21 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

ANSI/AAMI/ISO 80601-2-35:2009/ A1:2016

Amendment 1 of Medical electrical equipment-Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

IEC 60601-2-36:1997 Medical electrical equipment, Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

IEC 60601-2-36:2014 Medical electrical equipment, Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

IEC 60601-2-37:2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC 60601-2-37:2007 + AMD1:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC 60601-2-38:1996 Medical electrical equipment, Part 2-38: Particular requirements for the safety of electrically operated hospital beds

IEC 60601-2-38:1996/A1:1999 Amendment to IEC 60601-2-38:1996: Medical electrical equipment, Part 2-38: Particular requirements for the safety of electrically operated hospital beds

IEC 60601-2-39:2007 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

IEC 60601-2-40:1998 Medical electrical equipment, Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

IEC 60601-2-41:2000 Medical electrical equipment, Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis

IEC 60601-2-43:2000 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures

IEC 60601-2-43:2010 Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

IEC 60601-2-43:2010 + AMD1:2017 Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

IEC 60601-2-44:2009 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

IEC 60601-2-44:2009+ AMD2:2016


3.2 This consolidated version consists of the third edition (2009) and its amendment 2 (2016-03)).

IEC 60601-2-45:2001 Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

IEC 60601-2-45:2011 + AMD1:2015


60601-2-45:2011, third edition, 2011-02 +A1:2015)

IEC 60601-2-46:1998 Medical electrical equipment, Part 2-46: Particular requirements for the safety of operating tables

IEC 60601-2-47:2001 Medical electrical equipment, Part 2-47: Particular requirements for the safety of ambulatory electrocardiographic monitors (Holter monitors)

ANSI/AAMI/IEC 60601-2-47:2012 Medical electrical equipment, Part 2-47: Particular requirements for the safety and essential performance of ambulatory electrocardiographic systems

http://webstore.ansi.org/RecordDetail.aspx?sku=ANSI%2fAAMI%2fIEC+60601-2-47%3a2012

Page 22 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

ANSI/AAMI EC38:2007 Medical electrical equipment - Part 2: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

IEC 60601-2-49:2001 Medical electrical equipment, Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

IEC 60601-2-50:2000 Medical electrical equipment, Part 2-50: Particular requirements for the safety of infant phototherapy equipment

IEC 60601-2-50:2009 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

ANSI/AAMI/IEC 60601-2-50:2006 Medical electrical equipment, Part 2-50: Particular requirements for the safety of infant phototherapy equipment

ANSI/AAMI/IEC 60601-2-50:2009 Medical electrical equipment, Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

ANSI/AAMI/IEC 60601-2-50:2009/(R)2014 + AMD1:2016

Amendment 1 of Medical electrical equipment, Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

IEC 60601-2-51:2003 Medical electrical equipment, Part 2-51: Particular requirements for the safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

IEC 60601-2-52:2009 Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

IEC 60601-2-52:2009 + AMD1:2015 Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

IEC 60601-2-54:2009 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 60601-2-54:2009 + AMD1:2015 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

ISO 80601-2-55:2011 Medical electrical equipment – Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 80601-2-55:2018 Medical electrical equipment – Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

IEC 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

IEC 60601-2-57:2011

Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

ANSI/AAMI/IEC 80601-2-58:2014 Medical Electrical Equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

ANSI/AAMI/IEC 80601-2-58:2014/ A1:2016

Amendment 1 of Medical Electrical Equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

IEC 80601-2-59:2017

Technical Corrigendum 1:2011 to CAN/CSA-C22.2 No. 80601-2-59-10, Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

IEC 80601-2-60:2012 Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

ISO 80601-2-61:2011 Medical electrical equipment – Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment

Page 23 of 24 DQD 529.02 Rev 2018-11-07

Standard Title

ISO 80601-2-61:2011 + AMD1:2017 Medical electrical equipment – Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment

IEC 60601-2-62:2013 Medical electrical equipment – Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment.

IEC 60601-2-63:2012 + AMD1:2017 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

IEC 60601-2-64:2014

Medical electrical equipment – Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam ME

Equipment

IEC 60601-2-65:2012 + AMD1:2017 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

IEC 60601-2-68:2014

Medical electrical equipment - Part 2-68: Particular requirements for basic safety and essential performance of X-ray based image guided radiotherapy equipment for use with electron accelerators, light ion beam therapy systems and radionuclide beam therapy systems

ISO 80601-2-69:2014 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

ISO 80601-2-70:2015 Medical electrical equipment – Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnea breathing therapy equipment

ISO 80601-2-72:2015 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

ISO 80601-2-74:2017 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

IEC 60601-3-1:1996 Medical electrical equipment, Part 3-1: Particular requirements for the performance of transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment

ANSI/AAMI/IEC 62304:2006 Medical Device software – Software life cycle processes

ANSI/AAMI/IEC 62304:2006/A1:2016 Amendment 1 of Medical Device software – Software life cycle processes

ANSI/AAMI/IEC 62366:2007 Medical devices – Application of usability engineering to medical devices

ANSI/AAMI/IEC 62366:2007(R)2013/A1:2013

Medical devices – Application of usability engineering to medical devices, Amendment 1

ANSI/AAMI/IEC 62366-1:2015 Medical devices – Part1: Application of usability engineering to medical devices

UL 1069 Hospital Signaling and Nurse Call Equipment Seventh Edition, Dated

October 12, 2007 Note 1:Since standards are in continuous evolution the attachments above reflect a snap shot in time of the applicable standards. Additional standards and/or deletion of standards above are an ongoing activity. Persons using this INFORM must validate the applicable standards (editions, amendments, national differences, corrections, etc…) to their product as per date of application.

http://webstore.ansi.org/RecordDetail.aspx?sku=ANSI%2fAAMI%2fIEC+62304%3a2006

http://webstore.ansi.org/RecordDetail.aspx?sku=ANSI%2fAAMI%2fIEC+62304%3a2006

http://webstore.ansi.org/RecordDetail.aspx?sku=ANSI%2fAAMI+HE75+and+ANSI%2fAAMI%2fIEC+62366+Human+Factor+Set




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ATTACHMENT 5

Background and Rationale

CAN/CSA-C22.2 No. 60601-1 and ANSI/AAMI ES60601-1 Part 1 and Part 2 Series standards are based on the IEC (International Electro Technical Commission) Publications of 60601-1-XX and 60601-2-XX Series. Canadian and American Deviations are presented in the pages preceding the body of each National Standard. The 60601-2-XX Series of Standards contain particular requirements that amend and supplement the applicable, "General Standards" (Part 1). The "Particular (Part 2) Requirements" series of Standards take precedence over those of the General Standards. For Certification, equipment must meet the combined requirements, as applicable, of both the Particular Requirements Standard and the General Standard including collaterals as per applicable editions. Previous editions of collaterals and particulars can be used in conjunction with the new edition standards if the applicable standard are not published or adopted in Canada. Every effort has been made to ensure that the harmonization of existing Canadian Standards with International practice preserves the welfare of the patients and users.

Documents

An Urgent Bulletin from CSA Group€¦ · edition adopted IEC 60601/80601 standards series; collaterals, particulars (part 2) standards and others Addition of new standards Standard