93-42-EC ER Checklist Example

7/28/2019 93-42-EC ER Checklist Example

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Medical Devices Directive Compliance Essential Requirements ChecklistProduct: Bubble Humidifier Product/Product Group: ABC Series Completed by: J Bloggs Date: 22.10.12

Standard used for compliance:

Medical Devices Council Directive 93/42/EECAnnex I (consolidated as per 2007/47/EEC)

BS EN ISO 8185:2009

Basis of Compliance:

Product compliance has been based on in-house testing, externalevaluation, evaluation of sales/complaints history, equivalence to

other products or a combination of this data.

Product Status: (New or Well Established):

Well Established product

Released 22.10.10

Template reference: 123 1 of 16

I. General Requirements Applicableor N/A

Compliance Details/Assessment References

1. The devices must be designed and manufactured in such a way that,when used under the conditions and for the purposes intended, they willnot compromise the clinical condition or the safety of patients, or thesafety and health of users or, where applicable, other persons, providedthat any risks which may be associated with their intended useconstitute acceptable risks when weighed against the benefits to thepatient and are compatible with a high level of protection of health andsafety.

This shall include: reducing, as far as possible, the risk of use error due to the ergonomicfeatures of the device and the environment in which the device isintended to be used (design for patient safety), and

consideration of the technical knowledge, experience, education andtraining and where applicable the medical and physical conditions ofintended users (design for lay, professional, disabled or other users).

A Certified by Notified Body to ISO 9001:2008 & ISO 13485:2012.

Compliance to BS EN ISO 8185:2009.

Well established product range.

Ergonomic features part of design considerations.

Simple design concept.

ISO 9001 &13485 Certs.

Technical File

Complaintanalysis

2. The solutions adopted by the manufacturer for the design andconstruction of the devices must conform to safety principles, takingaccount of the generally acknowledged state of the art.

In selecting the most appropriate solutions, the manufacturer must applythe following principles in the following order:

eliminate or reduce risks as far as possible (inherently safe design and

construction),

where appropriate take adequate protection measures includingalarms if necessary, in relation to risks that cannot be eliminated,

inform users of the residual risks due to any shortcomings of theprotection measures adopted.

A Complies with BS EN ISO 8185:2009.

From complaints history review no risk identified.

Inherently safe and simple design.

Safety/operating instruction leaflet.

Technical File

Instructionsfor use

3. The devices must achieve the performances intended by themanufacturer and be designed, manufactured and packaged in such away that they are suitable for one or more of the functions referred to in

A Compliance to BS EN ISO 8185:2009.

Designed to ISO 9001:2008 & ISO 13485:2012 Quality Systems. CompanyStandard Operating Procedures (SOP file).

Technical File


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Article 1 (2) (a), as specified by the manufacturer.

4. The characteristics and performances referred to in Sections 1, 2 and 3must not be adversely affected to such a degree that the clinicalconditions and safety of the patients and, where applicable, of otherpersons are compromised during the lifetime of the device as indicatedby the manufacturer, when the device is subjected to the stresses whichcan occur during normal conditions of use.


From complaints history review no risk identified.

Technical File

5. The devices must be designed, manufactured and packed in such a waythat their characteristics and performances during their intended use willnot be adversely affected during transport and storage taking account ofthe instructions and information provided by the manufacturer.


Works Instructions: All products separately identifiedWell Established Product. From Complaints History Review: No New RiskIdentified.

Tech. File

WorkInstructions

6. Any undesirable side-effect must constitute an acceptable risk whenweighed against the performances intended.

A Well Established Product. From Complaints History Review: No New RiskIdentified.

Technical File


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6a. Demonstration of conformity with the essential requirements mustinclude a clinical evaluation in accordance with Annex X.

A Bubble Humidifiers are fairly simple devices to be used in conjunction withmedical gas delivery, as the name implies they are intended to humidify thegas supplied to a patient. They consist of an inlet port that is connected to atube and diffuser. The diffuser sits in a reservoir of water inside the bottleand this breaks the gas into small bubbles. The humidified gas then flows outof the outlet to the patient. The ACME device follows this basic design.Design, performance, intended use and safety aspects of devices equivalentto the ACME device are outlined in the literature referenced below.

It is known that these devices are not very efficient in terms of humidityoutput and are primarily intended to use with Oxygen

1. However they can

adequately condition medical gases2. It is acknowledged that there are

numerous models and manufacturers of such devices e.g. Ohmeda, and

their instructions for safe use is fairly generic4. There have been a number ofalerts with such devices in the USA, these have related to leakage e.g. dueto missing parts

5,6. There has been one recent UK recall for a similar device

that had a faulty part7

(not present on ACME device).

1. Basic Lab Competencies for Respiratory Care; Gary C White;Thomson Delmar Learning; 2002; page 262.

2. Intensive Care Medicine: Annual Update 2003; Jean-Louis Vincent;page 258.

3. Working in the Operating Department; Bakul Kumar; ElservierHealth Sciences; 1998; page 158.

4. Equipment Theory for Respiratory Care; Gary C White; ThomsonDelmar Learning; 1998.

5. FDA Catalogue Number 006-01; 10/04/1996;Hudson RCI BubbleHumidifier.

6. FDA Catalogue Number 2D0803; 10/08/2002; Alligiance Pre-filledBubble Humidifier.

7. MDA/2007/061; Hudson RCI large volume nebuliser;13 August2007

The device has been designed using design input from existing products thathave been supplied by ACME acting as agents for approximately 20 years.There have never been any complaints or adverse events associated withthis current or previously supplied devices. As such there is no recordedfurther clinical data specific to the ACME device, except re-order data.

MedicalDeviceLiterature File

Technical File

Also furtherreferences atend of BS ENISO8185:2009(pages 48 &49)


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II. Requirements Regarding Design & Construction

7. Chemical, physical and biological properties.

7.1 The devices must be designed and manufactured in such a way as toguarantee the characteristics and performances referred to in SectionI on the General requirements. Particular attention must be paid to:

the choice of materials used, particularly as regards toxicity and,where appropriate, flammability,

the compatibility between the materials used and biological tissues,cells and body fluids, taking account of the intended purpose of thedevice,

where appropriate, the results of biophysical or modelling researchwhose validity has been demonstrated beforehand.

A Physical construction compliance to BS EN ISO 8185:2009.

Well Established Product. From Complaints History Review & RiskManagement - No New Risk Identified.Food grade materials used.

Not an intended used.

No such studies conducted or required.

Tech. file

7.2 The devices must be designed, manufactured and packed in such away as to minimize the risk posed by contaminants and residues tothe persons involved in the transport, storage and use of the devicesand to the patients, taking account of the intended purpose of theproduct. Particular attention must be paid to the tissues exposed andto the duration and frequency of exposure.


From Complaints History Review: No New Risk Identified.

Handling, Packing, Storage, Preservation & Delivery

Tech. File

SOP 6

7.3 The devices must be designed and manufactured in such a way thatthey can be used safely with the materials, substances and gaseswith which they enter into contact during their normal use or duringroutine procedures; if the devices are intended to administermedicinal products they must be designed and manufactured in sucha way as to be compatible with the medicinal products concernedaccording to the provisions and restrictions governing these productsand that their performance is maintained in accordance with theintended use.

A BS EN ISO 14971:2009 - Risk Management

Well Established Product. From Complaints History Review: No New RiskIdentified

Tech. file

7.4 Where a device incorporates, as an integral part, a substance which,if used separately, may be considered to be a medicinal product asdefined in Article 1 of Directive 2001/83/EC and which is liable to actupon the body with action ancillary to that of the device, the quality,safety and usefulness of the substance must be verified by analogy

N/A No medicinal products incorporated.


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with the methods specified in Annex I to Directive 2001/83/EC.

For the substances referred to in the first paragraph, the notified bodyshall, having verified the usefulness of the substance as part of themedical device and taking account of the intended purpose of thedevice, seek a scientific opinion from one of the competentauthorities designated by the Member States or the EuropeanMedicines Agency (EMEA) acting particularly through its committeein accordance with Regulation (EC) No 726/2004 [*] on the qualityand safety of the substance including the clinical benefit/risk profile ofthe incorporation of the substance into the device. When issuing itsopinion, the competent authority or the EMEA shall take into accountthe manufacturing process and the data related to the usefulness of

incorporation of the substance into the device as determined by thenotified body.

Where a device incorporates, as an integral part, a human bloodderivative, the notified body shall, having verified the usefulness ofthe substance as part of the medical device and taking into accountthe intended purpose of the device, seek a scientific opinion from theEMEA, acting particularly through its committee, on the quality andsafety of the substance including the clinical benefit/risk profile of theincorporation of the human blood derivative into the device. Whenissuing its opinion, the EMEA shall take into account themanufacturing process and the data related to the usefulness ofincorporation of the substance into the device as determined by thenotified body.

Where changes are made to an ancillary substance incorporated in a

device, in particular related to its manufacturing process, the notifiedbody shall be informed of the changes and shall consult the relevantmedicines competent authority (i.e. the one involved in the initialconsultation), in order to confirm that the quality and safety of theancillary substance are maintained. The competent authority shalltake into account the data related to the usefulness of incorporationof the substance into the device as determined by the notified body,in order to ensure that the changes have no negative impact on theestablished benefit/risk profile of the addition of the substance in themedical device.

N/A

N/A

N/A

No medicines in the product.

No blood derivatives incorporated.

No ancillary substances.


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When the relevant medicines competent authority (i.e. the oneinvolved in the initial consultation) has obtained information on theancillary substance, which could have an impact on the establishedbenefit/risk profile of the addition of the substance in the medicaldevice, it shall provide the notified body with advice, whether thisinformation has an impact on the established benefit/risk profile of theaddition of the substance in the medical device or not. The notifiedbody shall take the updated scientific opinion into account inreconsidering its assessment of the conformity assessmentprocedure.

N/A No ancillary substances

7.5 The devices must be designed and manufactured in such a way as toreduce to a minimum the risks posed by substances leaking from the

device. Special attention shall be given to substances which arecarcinogenic, mutagenic or toxic to reproduction, in accordance with

Annex I to Council Directive 67/548/EEC of 27 June 1967 on theapproximation of laws, regulations and administrative provisionsrelating to the classification, packaging and labelling of dangeroussubstances.

If parts of a device (or a device itself) intended to administer and/orremove medicines, body liquids or other substances to or from thebody, or devices intended for transport and storage of such bodyfluids or substances, contain phthalates which are classified ascarcinogenic, mutagenic or toxic to reproduction, of category 1 or 2,in accordance with Annex I to Directive 67/548/EEC, these devicesmust be labelled on the device itself and/or on the packaging for eachunit or, where appropriate, on the sales packaging as a device

containing phthalates.

If the intended use of such devices includes treatment of children ortreatment of pregnant or nursing women, the manufacturer mustprovide a specific justification for the use of these substances withregard to compliance with the essential requirements, in particular ofthis paragraph, within the technical documentation and, within theinstructions for use, information on residual risks for these patientgroups and, if applicable, on appropriate precautionary measures.

A

N/A

N/A

Compliance to BS EN ISO 8185:2009.

Product Performance designed not to leak.No risk identified.

No phthalates in materials.

No phthalates in materials.

Tech. file


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7.6 Devices must be designed and manufactured in such a way as toreduce, as much as possible, risks posed by the unintentional ingressof substances into the device taking into account the device and thenature of the environment in which it is intended to be used.


Well established Product.Complaints History Review & Risk ManagementNo New Risks Identified.

Tech. file

Complaintsrecord

8. Infection and microbial contamination.

8.1 The devices and manufacturing processes must be designed in sucha way as to eliminate or reduce as far as possible the risk of infectionto the patient, user and third parties. The design must allow easyhandling and, where necessary, minimize contamination of the deviceby the patient or vice versa during use.

A All parts of the Humidifier Assembly may be steamed/autoclaved cleaned toa temperature of 121C for a cycle not greater than 8 minutes. This isdetailed in the Safety & Operating Instructions.

Technical File

Instructionsfor use

8.2 Tissues of animal origin must originate from animals that have beensubjected to veterinary controls and surveillance adapted to theintended use of the tissues.

Notified bodies shall retain information on the geographical origin ofthe animals.

Processing, preservation, testing and handling of tissues, cells andsubstances of animal origin must be carried out so as to provideoptimal security. In particular safety with regard to viruses and othertransmissible agents must be addressed by implementation ofvalidated methods of elimination or viral inactivation in the course ofthe manufacturing process.

N/A No tissues of animal origin.

8.3 Devices delivered in a sterile state must be designed, manufacturedand packed in a non-reusable pack and/or according to appropriate

procedures to ensure that they are sterile when placed on the marketand remain sterile, under the storage and transport conditions laiddown, until the protective packaging is damaged or opened.

N/A Not a sterile product.

8.4 Devices delivered in a sterile state must have been manufacturedand sterilized by an appropriate, validated method.


8.5 Devices intended to be sterilized must be manufactured inappropriately controlled (e. g. environmental) conditions.

N/A All parts of the Humidifier Assembly may be steamed/autoclaved, but this isnot necessarily intended.

Instructionsfor use


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8.6 Packaging systems for non-sterile devices must keep the productwithout deterioration at the level of cleanliness stipulated and, if thedevices are to be sterilized prior to use, minimize the risk of microbialcontamination; the packaging system must be suitable taking accountof the method of sterilization indicated by the manufacturer.

A Procedure - Handling, Packing, Storage, Preservation & Delivery SOP 6

8.7 The packaging and/or label of the device must distinguish betweenidentical or similar products sold in both sterile and non-sterilecondition.


9. Construction and environmental properties.

9.1 If the device is intended for use in combination with other devices or

equipment, the whole combination, including the connection systemmust be safe and must not impair the specified performances of thedevices. Any restrictions on use must be indicated on the label or inthe instructions for use.

A The Humidifier has been designed to be used with other devices (e.g.

Flowmeters) and this does not affect the quality and performance of theproduct. It has been designed in accordance with BS EN ISO 8185:2009.

Technical File

9.2 Devices must be designed and manufactured in such a way as toremove or minimize as far as is possible:

the risk of injury, in connection with their physical features,including the volume/pressure ratio, dimensional and whereappropriate ergonomic features,

risks connected with reasonably foreseeable environmentalconditions, such as magnetic fields, external electrical influences,electrostatic discharge, pressure, temperature or variations inpressure and acceleration,

the risks of reciprocal interference with other devices normally usedin the investigations or for the treatment given,

risks arising where maintenance or calibration are not possible (aswith implants), from ageing of materials used or loss of accuracy ofany measuring or control mechanism.

A

A

A

N/A

Construction complies with BS EN ISO 8185:2009 and it is designed towithstand 2.5 times the normal medical gas pressure (4 bar).

See Risk Analysis.

A flowmeter can be attached, but this adds no risk, in fact can aid use.

No measuring function other liquid level scale.

Technical File

RiskManagement

9.3 Devices must be designed and manufactured in such a way as tominimize the risks of fire or explosion during normal use and in singlefault condition. Particular attention must be paid to devices whoseintended use includes exposure to flammable substances or to

A The Humidifier has been designed to minimise the risk of ignition/explosionwhen used with Oxygen.

No risk identified.

Technical File


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substances which could cause combustion.

10. Devices with a measuring function.

10.1 Devices with a measuring function must be designed andmanufactured in such a way as to provide sufficient accuracy andstability within appropriate limits of accuracy and taking account ofthe intended purpose of the device. The limits of accuracy must beindicated by the manufacturer.

N/A No direct measuring function.

10.2 The measurement, monitoring and display scale must be designed inline with ergonomic principles, taking account of the intendedpurpose of the device.


10.3 The measurements made by devices with a measuring function mustbe expressed in legal units conforming to the provisions of CouncilDirective 80/181/EEC (1).


11. Protection against radiation.

11.1 General.

11.1.1 Devices shall be designed and manufactured in such a way thatexposure of patients, users and other persons to radiation shall bereduced as far as possible compatible with the intended purpose,whilst not restricting the application of appropriate specified levels fortherapeutic and diagnostic purposes.

N/A No radiation emitted.

11.2 Intended radiation.

11.2.1 Where devices are designed to emit hazardous levels of radiationnecessary for a specific medical purpose the benefit of which isconsidered to outweigh the risks inherent in the emission, it must bepossible for the user to control the emissions. Such devices shall bedesigned and manufactured to ensure reproducibility and tolerance ofrelevant variable parameters.


11.2.2 Where devices are intended to emit potentially hazardous, visible N/A No radiation emitted.

1 OJ No L 39, 15, 2, 1980, p.40. Directive as last amended by Directive 89/617/EEC (OJ No L 357,7,12,1989, p.28)


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and/or invisible radiation, they must be fitted, where practicable, withvisual displays and/or audible warnings of such emissions.

11.3 Unintended radiation

11.3.1 Devices shall be designed and manufactured in such a way thatexposure of patients, users and other persons to the emissions ofunintended, stray or scattered radiation is reduced as far as possible.


11.4 Instructions

11.4.1 The operating instructions for devices emitting radiation must givedetailed information as to the nature of the emitted radiation, meansof protecting the patient and the user and on ways of avoiding misuse

and of eliminating the risks inherent in installation.


11.5 Ionising radiation

11.5.1 Devices intended to emit ionising radiation must be designed andmanufactured in such a way as to ensure that, where practicable, thequantity, geometry and quality of radiation emitted can be varied andcontrolled taking into account the intended use.


11.5.2 Devices emitting ionising radiation intended for diagnostic radiologyshall be designed and manufactured in such a way as to achieveappropriate image and/or output quality for the intended medicalpurpose whilst minimising radiation exposure of the patient and user.


11.5.3 Devices emitting ionising radiation intended for therapeutic radiologyshall be designed and manufactured in such a way as to enable

reliable monitoring and control of the delivered dose, the beam typeand energy and where appropriate the quality of radiation.


12. Requirements for medical devices connected to or equippedwith an energy source.

12.1 Devices incorporating electronic programmable systems must bedesigned to ensure the repeatability, reliability and performance ofthese systems according to the intended use. In the event of a singlefault, condition (in the system) appropriate means should be adopted

N/A Not electronic.


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to eliminate or reduce as far as possible consequent risks.

12.1a For devices which incorporate software or which are medicalsoftware in themselves, the software must be validated according tothe state of the art taking into account the principles of developmentlifecycle, risk management, validation and verification.

N/A Not electronic.

12.2 Devices where the safety of the patients depends on an internalpower supply must be equipped with a means of determining thestate of the power supply.

N/A Not electronic.

12.3 Devices where the safety of the patients depends on an externalpower supply must include an alarm system to signal any powerfailure.

N/A Not powered.

12.4 Devices intended to monitor one or more clinical parameters of apatient must be equipped with appropriate alarm systems to alert theuser of situations which could lead to death or severe deterioration ofthe patients state of health.

N/A No monitoring function.

12.5 Devices must be designed and manufactured in such a way as tominimise the risks of c reating electromagnetic fields which couldimpair the operation of other devices or equipment in the usualenvironment.

N/A Not electronic.

12.6 Protection against electrical risks.

Devices must be designed and manufactured in such a way as toavoid, as far as possible, the risk of accidental electric shocks duringnormal use and in single fault condition, provided the devices are

installed correctly.

N/A Not electronic.

12.7 Protection against mechanical and thermal risks.

12.7.1 Devices must be designed and manufactured in such a way as toprotect the patient and user against mechanical risks connected with,for example, resistance, stability and moving parts.

A Safety characteristics comply with BS EN ISO 8185:2009. Technical File

12.7.2 Devices must be designed and manufactured in such a way as toreduce to the lowest possible level the risks arising from vibrationgenerated by the devices, taking account of technical progress and of

N/A No vibration generated.


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the means available for limiting vibrations, particularly at source,unless the vibrations are part of the specified performance.

12.7.3 Devices must be designed and manufactured in such a way as toreduce to the lowest possible level the risks arising from the noiseemitted, taking account of technical progress and of the meansavailable to reduce noise, particularly at source, unless the noiseemitted is part of the specified performance.

N/A No noise generated.

12.7.4 Terminals and connectors to the electricity, gas or hydraulic andpneumatic energy supplies which the user has to handle must bedesigned and constructed in such a way as to minimise all possiblerisks.

A Complies with BS EN ISO 8185:2009.

No risk identified/

Technical File

12.7.5 Accessible parts of the devices (excluding the parts or areasintended to supply heat or reach given temperatures) and theirsurroundings must not attain potentially dangerous temperaturesunder normal use.

N/A Cannot generate heat.

12.8 Protection against the risks posed to the patient by energy suppliesor substances.

12.8.1 Devices for supplying the patient with energy or substances must bedesigned and constructed in such a way that the flow-rate can be setand maintained accurately enough to guarantee the safety of thepatient and of the user.

A The flow rate through the device is intended to regulated by a Flowmeterwhich should conform to BS EN ISO 15002:2008.

Technical File

Instructionsfor use

12.8.2 Devices must be fitted with the means of preventing and/or indicatingany inadequacies in the flow-rate which could pose a danger.

Devices must incorporate suitable means to prevent, as far aspossible, the accidental release of dangerous levels of energy froman energy and/or substance source.

A

A

Complies with BS EN ISO 8185:2009.


Technical File

12.9 The function of the controls and indicators must be clearly specifiedon the devices.

Where a device bears instructions required for its operation orindicates operating or adjustment parameters by means of a visualsystem, such information must be understandable to the user and, as

A

A


Fluid level indicator marked on product.

Technical FileInstructionsfor use


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appropriate, the patient.

13. Information supplied by the manufacturer.

13.1 Each device must be accompanied by the information needed to useit safely and properly, taking account of the training and knowledge ofthe potential users, and to identify the manufacturer.

This information comprises the details on the label and the data in theinstructions for use.

As far as practicable and appropriate, the information needed to usethe device safely must be set out on the device itself and/or on thepackaging for each unit or, where appropriate, on the salespackaging. If individual packaging of each unit is not practicable, the

information must be set out in the leaflet supplied with one or moredevices.

Instructions for use must be included in the packaging for everydevice. By way of exception, no such instructions for use are neededfor devices in Class I or IIa if they can be used safely without anysuch instructions.

A

A

A

A

Operation & Safety Instructions comply with BS EN ISO 8185:2009 (see BSEN 1041:2008 for IFU guidance).

Product is identified by means of labelling.

Operation & Safety Instruction leaflet.

Product is Class IIa device. Operation & Safety Instructions and supplyinformation in accordance with BS EN ISO 8185:2009. Note: the product isvery simple and can be safely used without instructions.

Technical File

Technical File/ OperatingInstructions

13.2 Where appropriate, this information should take the form of symbols.Any symbol or identification colour used must conform to theharmonized standards. In areas for which no standards exist, thesymbols and colours must be described in the documentationsupplied with the device.

A Markings used comply with BS EN ISO 8185:2009 and symbols used in IFUand labelling with BS EN ISO 15223-1.

Technical File

13.3 The label must bear the following particulars:

(a) the name or trade name and address of the manufacturer. Fordevices imported into the Community, in view of their distribution inthe Community, the label, or the outer packaging, or instructions foruse, shall contain in addition the name and address of the authorisedrepresentative where the manufacturer does not have a registeredplace of business in the Community;

(b) the details strictly necessary to identify the device and thecontents of the packaging especially for the users;

(c) where appropriate, the word STERILE;

A

A

N/A

The Humidifier instructions for use and the packaging label carry the nameand address of the company (manufactured in EC).

Identified by device product code.

Not Sterile.

Technical File/ labels


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(d) where appropriate, the batch code, preceded by the word LOT,or the serial number;

(e) where appropriate, an indication of the date by which the deviceshould be used, in safety, expressed as the year and month;

(f) where appropriate, an indication that the device is for single use. Amanufacturer's indication of single use must be consistent across theCommunity;

(g) if the device is custom-made, the words custom-made device;

(h) if the device is intended for clinical investigations, the wordsexclusively for clinical investigations;

(i) any special storage and/or handling conditions;

(j) any special operating instructions;

(k) any warnings and/or precautions to take;

(l) year of manufacture for active devices other than those covered by(e). This indication may be included in the batch or serial number;

(m) where applicable, method of sterilisation;

(n) in the case of a device within the meaning of Article 1(4a), anindication that the device contains a human blood derivative.

A

N/A

N/A

N/A

N/A

N/A

N/A

A

A

A

N/A

Each Humidifieris uniquely identified with Serial or Lot number.

However, each Humidifier packaging label carries the year and month ofmanufacture.Not single use.

Not custom made.

Not intended for clinical investigations.

None required.

No special instructions.

Precautions to take and safety instructions are on the leaflet.

Each Humidifier carries the year and month of manufacture on packaging.

Instructions for use indicate that the product can be autoclaved.

No blood derivatives incorporated.

OperatingInstructions

Label

OperatingInstructions

13.4 If the intended purpose of the device is not obvious to the user, themanufacturer must clearly state it on the label and in the instructionsfor use.

A Intended use should be clear, but instruction are on leaflet. OperatingInstructions

13.5 Wherever reasonable and practicable, the devices and detachable

components must be identified, where appropriate in terms ofbatches, to allow all appropriate action to detect any potential riskposed by the devices and detachable components.

A Component batches are recorded on the devices Product Kit List which is

applied throughout the quality system (ISO 13485:2012/ISO 9001:2008).Controlled by SOP18 Production Identification & Traceability.

.

SOP File

13.6 Where appropriate, the instructions for use must contain the followingparticulars:

(a) the details referred to in Section 13.3, with the exception of (d)and (e);

(b) the performances referred to in Section 3 and any undesirable

A

A



Technical File

Instructionsfor use


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Product compliance has been based on in-house testing, externalevaluation, evaluation of sales/complaints history, equivalence toother products or a combination of this data.



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side-effects;

(c) if the device must be installed with or connected to other medicaldevices or equipment in order to operate as required for its intendedpurpose, sufficient details of its characteristics to identify the correctdevices or equipment to use in order to obtain a safe combination;

(d) all the information needed to verify whether the device is properlyinstalled and can operate correctly and safely, plus details of thenature and frequency of the maintenance and calibration needed toensure that the devices operate properly and safely at all times;

(e) where appropriate, information to avoid certain risks in connectionwith implantation of the device;

(f) information regarding the risks of reciprocal interference posed bythe presence of the device during specific investigations or treatment;

(g) the necessary instructions in the event of damage to the sterilepackaging and, where appropriate, details of appropriate methods ofre-sterilisation;

(h) if the device is reusable, information on the appropriate processesto allow reuse, including c leaning, disinfection, packaging and, whereappropriate, the method of sterilization of the device to be re-sterilised, and any restriction on the number of reuses.

Where devices are supplied with the intention that they be sterilizedbefore use, the instructions for cleaning and sterilization must besuch that, if correctly followed, the device will still comply with therequirements in Section I;

If the device bears an indication that the device is for single use,information on known characteristics and technical factors known tothe manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use areneeded, the information must be made available to the user uponrequest;

(i) details of any further treatment or handling needed before thedevice can be used (for example, sterilisation, final assembly, etc.);

(j) in the case of devices emitting radiation for medical purposes,

A

A

N/A

N/A

N/A

A

N/A

N/A

Detailed in Safety & Operating Instructions.

Detailed in Safety & Operating Instructions.

Not implantable.

Not for specific investigations.

Not sterile.

The product is reusable after cleaning/disinfecting. Process instructions toallow reuse are defined in the Safety & Operating Instructions.

No further treatment required.

No radiation emitted.


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details of the nature, type, intensity and distribution of this radiation.

The instructions for use must also include details allowing themedical staff to brief the patient on any contra-indications and anyprecautions to be taken. These details should cover in particular:

(k) precautions to be taken in the event of changes in theperformance of the device;

(l) precautions to be taken as regards exposure, in reasonablyforeseeable environmental conditions, to magnetic fields, externalelectrical influences, electrostatic discharge, pressure or variations inpressure, acceleration, thermal ignition sources, etc.;

(m) adequate information regarding the medicinal product or products

which the device in question is designed to administer, including anylimitations in the choice of substances to be delivered;

(n) precautions to be taken against any special, unusual risks relatedto the disposal of the device;

(o) medicinal substances, or human blood derivatives incorporatedinto the device as an integral part in accordance with Section 7.4;

(p) degree of accuracy claimed for devices with a measuring function;

(q) date of issue or the latest revision of the instructions for use.

A

N/A

A

N/A

N/A

N/A

A

Details in Operating Instructions.

No exposure issues.

Intended to supply humidified air/oxygen details in Operating Instructions.

No unusual risks.

No medical/blood products.

No direct measuring function.

Given on Safety & Operating Instruction leaflet.

Based on the above evaluation and the supporting documentation the undersigned confirms that all applicable essential requirements are fulfilled.

Name: J Bloggs Signature: J Bloggs Position: Quality Manager

Documents

93-42-EC ER Checklist Example