LOREM IPSUMXXX

N° X • XXXXXXXX 2008XXX AUGUST • 2012MEDICAL DEVICES NEWS

REVIEW OF NEW ASEPTIC PROCESSING STANDARDS PAGE 02

E-LABELLING FOR EUROPE PAGE 04

IEC 60601 PUBLISHES NEW STANDARD SPECIFIC TO DEVICES FOR THE HOME HEALTHCARE ENVIRONMENT PAGE 05

IEC 62366 DEVELOPING PRODUCT USABILITY AND CREATING OPPORTUNITIES FOR COMPETITIVE ADVANTAGE PAGE 06

EN ISO 13485:2012 PAGE 08

SGS AT MEDICA 2012 – ‘GET YOUR PRODUCT TO MARKET FASTER, WE KNOW THE WAY’ PAGE 09

SPECIAL POINTS OF INTEREST:

MEDICAL DEVICES NEWS AUGUST 2012

EDITORIAL

Dear Reader,

Welcome to another issue of our Medical Devices Newsletter.

Within this issue you will find the latest information on current key industry issues, including:

• New Aseptic Standards ISO 13408

• E-labelling

• IEC 60601 new requirements for home used devices

• IEC 62366 developing product us-ability

• EN ISO 13485:2012

We hope you find this issue informative and useful!

Best regards, SGS Medical Devices Expert Team

P. 2N° X • XXXXXXXX 2008XXX P. 2AUGUST • 2012

REVIEW OF NEW ASEPTIC PROCESSING STANDARDS

MEDICAL DEVICES NEWS

As of 31 December 2011, EN 13824:2004 (Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements) can no longer be used to provide a presumption of conformity with Essential Requirements of the Medical Device Directive 93/42/EEC, and the In Vitro Diagnostic Medical Device Directive 98/79/EC. The standard is replaced by the international ISO 13408 series of standards.

INTRODUCTION TO ASEPTIC PROCESSING

Have you ever wondered what means? It is the symbol for sterile using aseptic processing techniques. If you are a contact lens wearer you are likely to have seen it on your lens solution packaging. It is also typically used with other ophthalmic medical devices such as drops for dry eyes and certain other medical devices that are similar to pharmaceutical liquids.

In Terminal Sterilization devices are packed and sealed under a high level of environmental control ‘clean room’ conditions. Devices in their final product containers are then subjected to a sterilisation process:

• sterilized using steam or dry heat• sterilized using ethylene oxide• sterilized using radiation

Aseptic manufacturing is used if the device cannot be sterilized in its final container for example if the device is heat sensitive and will become unstable. In Europe it is seen as the last resort and should only be used if all methods of terminal sterilization have been excluded.

In aseptic processing the highest levels of environment control are used. Device containers and closures are first subjected to validated sterilization by a terminal method. Sterility of the device is achieved by filtering bulk solution through a bacteria retaining filter into the final sterile product containers.

The entire process is validated by conducting a media fill where microbiological nutrient media is used instead of the medical device. The filled and sealed containers are incubated and inspected for any microbial growth. The media fill simulates the normal manufacturing process including

environment and personnel control, cleaning and sterilisation of manufacturing equipment (cleaning in place CIP and sterilization in place SIP); sterilization of containers and closures; device compounding and mixing; sterile filtration and filling.

Lyophilization (freeze drying) is a physical drying process that involves freezing a solution and removing solvent to a level such that the product no longer supports chemical reactions or biological growth - primarily to achieve product stability. If lyophilizaton of sterile solution is required, then controls are required to ensure no contamination of the solution (from microbiological and particulate contamination) between the filling operation and completion of the lyophilization process.

CHANGES IN THE STANDARDS

The existing ISO standards for Aseptic processing (e.g. as used in pharmaceutical manufacturing) have become harmonised within Europe, and are published as EN ISO standards. Although the principles of Aseptic Processing remain the same, the EN ISO 13408 series of standards specify requirements in much more depth, and have some additional requirements.

So manufacturers who use aseptic processing will need to obtain the latest versions of standards to identify if existing processes and procedures are compliant and to identify any improvement actions. Notified Bodies will start to use the new standards to assess the technical documentation and processes used by manufacturers of CE marked products.

P. 3N° X • XXXXXXXX 2008XXX P. 3AUGUST • 2012MEDICAL DEVICES NEWS

SUMMARY OF ISO 13408 STANDARDS

1. EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements (Equivalent to ISO 13408-1:2008).

The standard specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. It includes requirements and guidance relative to the overall topic of aseptic processing.

2. EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (Equivalent to ISO 13408-2:2003).

The standard specifies requirements for sterilizing filtration as part of aseptic pro-cessing of health care products. It also offers guidance to filter users concerning general requirements for set-up, valida-tion and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.

3. EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (Equivalent to ISO 13408-3:2006).

ISO 13408-3 specifies requirements for, and offers guidance on, equipment,

processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

4. EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (Equivalent to ISO 13408-4:2005).

ISO 13408-4 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. It is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. It is not applicable to processes where equipment is dismantled and cleaned in a washer.

5. EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (Equivalent to ISO 13408-5:2006).

ISO 13408-5 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces

of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. It applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

6. EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (Equivalent to ISO 13408-6:2005).

ISO 13408-6 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. It is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.

A more detailed review of those parts of the EN ISO 13408 standards that are of most interest to medical device manufacturers and the areas where requirements are more detailed is available from SGS. Please email a request if this will be useful to you.

P. 4N° X • XXXXXXXX 2008XXX P. 4AUGUST • 2012MEDICAL DEVICES NEWS

E-LABELLING FOR EUROPE

SCOPE OF THE PROPOSED NEW REGULATION E-labelling will only be for devices exclusively used by professional users (home use devices will not be covered) and applicable to Medical Devices Directive 93/42/EEC (as amended by 2007/47/EC) and Active Implantable Medical Devices Directive 90/385/EEC.

Article 3 of the proposed new regulation defines the medical devices eligible for e-labelling, including:

• Standalone software (93/42/EEC)• Medical devices and their

accessories with a built-in system virtually displaying IFUs (93/42/EEC)

• Fixed installed medical devices (93/42/EEC)

• Implanted medical devices and their accessories (93/42/EEC)

• Active implantable devices (90/385/EEC)

(NB: A full review by manufacturers of Article 3 is recommended, as caveats to the above designations are included.) The use and provision of e-labelling will

remain at the discretion of the manufacturer and will not be mandatory for all medical devices.

RISK ASSESSMENT

Should a manufacturer decide to implement e-labelling, the completion of a documented risk assessment will be mandatory. Article 4 of the proposed new regulation identifies the specific requirements for the risk assessment. An important point of note is the need for the risk assessment to demonstrate that an e-label maintains or improves the level of safety attained by an equivalent IFU in paper format.

AVAILABILITY OF IFU IN ELECTRONIC FORMAT

Unless the risk assessment demonstrates clear justification for its omission, the electronic IFU will need to be available in all EU countries where the product is sold. In addition, the manufacturer will have to set up a website for access to the electronic

“A new regulation for medical devices on the use of electronic instructions for use (IFU), or e-labelling, has been approved by the EU Council and European Parliament. The new regulation will not require transposition into the laws of individual countries. This means manufacturers will have the option to implement e-labelling from March 2013 onwards.

IFU and have a system in place for the provision of the IFU in paper format. The paper IFU will have to be delivered within 7 days of request and at no added cost to the user.

Article 5 of the proposed new regulation describes further requirements placed on the manufacturer if they wish to use e-labelling.

CONFORMITY ASSESSMENT

During the annual regulatory audit, as part of the normal conformity assessment process, a manufacturer that chooses to use e-labelling (in accordance with the proposed new regulation) will have their implementation processes reviewed by the Notified Body.

SGS will not require notification in advance of any decision to use e-labelling.

The regulation can be viewed in full here: http://ec.europa.eu/enterprise/tbt/tbt_re-pository/EEC381_EN_1_1.pdf

P. 5N° X • XXXXXXXX 2008XXX P. 5AUGUST • 2012MEDICAL DEVICES NEWS

IEC 60601 PUBLISHES NEW STANDARD SPECIFIC TO DEVICES FOR THE HOME HEALTHCARE ENVIRONMENT

IEC 60601-1-11 (2010) outlines new mandatory requirements for the design and verification of a wide range of home use and point of care medical devices, along with other applicable standards in the IEC 60601 3rd edition series.

2012 FOR EU & US FDA, 2013 FOR HEALTH CANADA

Since June 1, 2012, the EN 60601 3rd edition series became mandatory for most applicable devices placed on the EU market. The US FDA set the implementation of the standard from June 30, 2013, while Health Canada extended its implementation date for IEC 60601-1-11 from June 2012 to April 2013. The North American agencies require these standards only for new device submissions but the EU require all applicable devices being placed on the market to comply.

DIFFERENCES IN DEFINITION

The IEC standard defines the Home Healthcare Environment as:

“…dwelling place in which a patient lives or other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.”

The IEC standard includes nursing homes within its definition; however,

the US national version of the standard – ANSI/AAMI HA60601-1-11 – does not specify the nursing home environment as applicable due to nursing facilities in the US being considered professional healthcare environments. The US version also differs by placing greater emphasis on a requirement that states: “inspection of the usability engineering file reinforce that the usability engineering process is necessary for validation of the instructions for use.”

The European EN and Canadian CSA versions are both identical to the IEC standard.

DEVICES COVERED BY THE NEW STANDARD

Devices typically mandated to use the new standard include:

• Oxygen concentrators• Body-worn nerve and muscle

stimulators• Beds• Sleep apnea monitors• Battery chargers prescribed for use at

home

In-vitro diagnostic devices (ie blood glucose meters for home use) do not apply as these devices are covered by the more lenient IEC 61010 series.

PROTECTING THE DEVICE AND THE USER

The new standard differs from the general IEC 60601-1 in relation to the requirements for construction and testing. Due to home-operators having

varying levels of experience, and the uncontrolled home-environment, there is a need to safeguard the functioning and integrity of devices against unintentional or unauthorised damage or tampering.

For construction, the standard requires the use of a two-prong (unearthed) plug, water-resistant casings, and that parts to be applied by a patient be isolated from other parts of the device. Devices are also tested to ensure no damage from:

• Mechanical shock• Vibration• Impact from dropping• Wider range of environmental

conditions (i.e. temperature, humidity, pressure, etc.)

These requirements go beyond the general 60601-1 standard. It is recommended to review testing-laboratories to ensure compliance across the entire range of new requirements. Simply addressing the very general risk concerns of ISO 14971, Application of risk management to medical devices, is no longer adequate to comply with the specific hardware-related aspects of IEC 60601.

To protect against unintentional improper use, the design and usability of the device (including any instructions and markings) assume a level of education of no more than eight years. Usability of the device is also dictated by the requirements of the collateral standard IEC 60601-1-6, with the third edition the preferred benchmark (and as of April 1, 2013, the third edition becomes mandatory in the EU).

CONCLUSION

IEC 60601 3rd edition series has, and still is, undergoing change with a recent amendment to the general requirements standard IEC 60601-1 which modifies and clarifies some of the existing requirements. A thorough review of any new, or existing, devices intended for the European or North American markets is highly recommended.

P. 6N° X • XXXXXXXX 2008XXX P. 6AUGUST • 2012MEDICAL DEVICES NEWS

IEC 62366 DEVELOPING PRODUCT USABILITY AND CREATING OPPORTUNITIES FOR COMPETITIVE ADVANTAGE

SAFETY AND COMPETITIVENESS THROUGH INCREASED USABILITY

A report in 1999 by the Institute of Medicine titled, ‘To Err is Human: Building A Safer Health System’ stated that at least 44,000 people, and perhaps as many as 98,000 people, die in US hospitals each year as a result of medical errors that could have been prevented. The report concluded that the

majority of medical errors were not a result of individual recklessness, instead the report warned that errors were due to faulty systems, processes and conditions that lead people to make mistakes or fail to prevent them.

Today, both the MDD and FDA require that human factors and risk of use errors be accounted for in the development of medical devices. International standards, such as IEC 60601-1 Ed3 and

IEC 60601-1 3rd edition requires that manufacturers must address the risk of poor usability, including those associated with identification, marking and documents). This is accomplished by performing a usability engineering process that complies with IEC 62366 ‘Application of usability engineering to medical devices’.

IEC 62366 GUIDANCE AND IMPLEMENTATION

IEC 62366 provides extensive guidance on how to implement usability engineering to minimise risks. The standard, a 100-page document, defines the user interface design cycle in medical context as shown below:

specifically IEC 60601-1-6, address usability engineering and aim to minimise risks caused by poor usability. In any situation where medical devices are used there is a responsibility to ensure only well-designed, ergonomic products make it to market. The easier a product is for the user, the safer it is for the patient, and consequently the product can increase its competitiveness in the market place.

Usability engineering as a cycle of steps.

P. 7N° X • XXXXXXXX 2008XXX P. 7AUGUST • 2012MEDICAL DEVICES NEWS

DESIGN CYCLE ELEMENT

SUBCLAUSE OF IEC 62366 METHODS

User research/ Conceptual design

5.1 Application specification

5.2 Frequently used functions

5.3.1 Identification of characteristics related to SAFETY

5.3.2 Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS

Interviews Observation Questionnaires User logbooks Workflow analysis Use cases

Requirement and Criteria Development

5.4 PRIMARY OPERATING FUNCTIONS

5.5 USABILITY SPECIFICATION USABILITY VALIDATION plan

5.6

Functional requirements Usability requirements:

• efficiency• freedom from

errors• time to learn

Detailed design and Specifications

5.7 USER INTERFACE design and implementation

Design procedures Style guides

Evaluation 5.8 USABILITY VERIFICATION USABILITY VALIDATION 5.9 Identification of known or foreseeable 5.3.2 HAZARDS and HAZARDOUS SITUATIONS

Expert analysis Heuristic evaluation Cognitive evaluation Reviews User tests: pair and group tests Observation

To more clearly understand how the steps of the design cycle relate to IEC 62366, the following table illustrates the usability engineering process:

BRINGING ALL PRODUCTS UP-TO-DATE

The design of many products that are already in use did not explicitly require usability engineering in their design. To address this problem, proposal 62A/799/DC exists to initiate a fast-track amendment to the IEC 62366 standard. The proposed amendment defines User Interface Of Unknown Provenance (UOUP). To evaluate UOUPs, a new Annex K is to enforce the usability engineering process to legacy devices, minor changes to legacy devices or to off-the-shelf components incorporated in medical devices.

CONCLUSION – ‘HOW TO DESIGN GOOD USABILITY?’

It is not possible to add good usability into a product as an afterthought. To meet the requirements of IEC 62366, usability engineering has to be incorporated into planning from day zero and the process needs to be recorded all the time. Regulations have made usability engineering a must, but at the same time good usability is a great distinguisher and part of a competitive advantage.

“There is a learning curve and there is a bad design. In many cases they are the same thing”

It is invaluable to ask and observe the actual users with regards to how they use competing equipment or rough early prototypes. If a user doesn’t need to ask instructions, or develop workarounds to accomplish what he/she intends to do, you are on the right track with your product. If you have, at the same time, crafted an aesthetically pleasant piece of equipment or software, you are about to create a winner!

P. 8N° X • XXXXXXXX 2008XXX P. 8 AUGUST • 2012MEDICAL DEVICES NEWS

EN ISO 13485:2012This standard will soon be the harmonised standard for quality management systems under EC Directives 90/385/EEC (Active Implantable Medical devices), 93/42/EEC ( Medical Devices) and 98/79/EC (In Vitro Diagnostic Medical Devices) . However as it contains no new requirements manufacturers that have been successfully audited by a Notified Body will not normally require any changes to their quality management system.

THE CHANGES

The scope, terminology and the requirements contained in sections 4 to 8 of EN ISO 13485:2012 are exactly the same as those in ISO 13485:2003. Thefore the ISO 13485 audit criteria

being assessed by a certification body or Notified Body have not changed.

The section that has been changed is the Foreword and in particular Annex ZA, Annex ZB and Annex ZC. These annexes link the clauses in ISO 13485:2003 with the requirements of the conformity assessment annexes of Directives 90/395/EEC, 93/42/EEC and 98/79/EC respectively. What these annexes now make clear is that the Directives have requirements which must be met by manufacturers in addition to meeting all the generic requirements in ISO 13485.

CERTIFICATES

As the requirements of ISO 13485 have not changed, certificates issued against ISO 13485:2003 will remain valid and no change in any certificate is strictly necessary. However for some time SGS have been indicating both ISO 13485:2003 the international version and EN ISO 13485:2003 + AC 2009 the

European harmonised version on all their UKAS accredited certificates. So when EN ISO 13485:2012 is officially harmonised (expected before the end of 2012) SGS will start to reference ISO 13485:2003 and EN ISO 13485:2012 on all new or amended certificates. The reference to ISO 13485 on CMDCAS certificates will not change as this scheme is based only on ISO 13485:2003. It is expected that other Notified Bodies will take similar action on certificates.

HARMONIZATION

Manufacturers can check the progress of the harmonisation of this standard on the EC Commission website: http://ec.europa.eu/enterprise/policies/euro-pean-standards/harmonised-standards/medical-devices/index_en.htm

For questions about EN ISO 13485:2012, please send us an Email medicaldevices@sgs.com

P. 9N° X • XXXXXXXX 2008XXX P. 9AUGUST • 2012MEDICAL DEVICES NEWS

SGS AT MEDICA 2012 – ‘GET YOUR PRODUCT TO MARKET FASTER, WE KNOW THE WAY’MEDICA 2012, the world’s most important trade fair for the medical sector will take place in Dusseldorf, Germany, from November 14-17. At this year’s event, SGS will share its exhibition stand with the Association of British Healthcare Industries (ABHI).

MEDICA 2012 (NOVEMBER 14-17, 2012)

MEDICA 2012 is the world’s most important trade fair for the medical sector, and this year SGS is sharing its exhibition stand with the Association of British Healthcare Industries (ABHI).

The long list of new medical technologies and applications to be presented at MEDICA 2012 demonstrates that the medical sector remains an industry that has innovation at its heart. More than 4 300 exhibitors, ranging from innovative newcomers to multinational heavyweights, are set to showcase their latest products across 17 exhibition halls, which cover almost 120 000m².

At MEDICA 2012 there is also a diversified supporting program of forums and conferences that span all four days of the event. The presentations inform and expand on a wide range of topics that include: health IT, healthcare

economics and visions for medical technologies of the future.

In an industry where timing and quality are everything, speed to market and trusted product processes give you the competitive edge. SGS offers fully integrated services for all medical device manufacturers, regardless of product or project size, or the span of target markets. We improve your efficiencies and reduce risk in your operations by combining our expertise in inspection, verification, testing and certification – allowing you to benefit from one global solution.

Partner with SGS and realise worldwide advantage in the medical sector.

P. 10N° X • XXXXXXXX 2008XXX

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