1、MedtronicRELEVANT STANDARDSTemplate 10060771, Rev. 202STANDARD NUMBER/REVISIONHARMONIZED STANDARD DESCRIPTIONEN ISO 13485:2016Medical devices Quality management systems Requirements for regulatory purposesEN ISO 14971:2012Medical devices Application of risk management to medical devicesEN ISO 15223-

2、1: 2016Medical devices Symbols to be used with medical device labels, labeling and information to be supplied Part 1: General RequirementsEN 1041:2008+ A1:2013Information supplied by the manufacturer of medical devicesEN 60601-1:2006 + A12:2014Medical Electrical Equipment - Part 1: General Requireme

3、nts for Safety - Collateral Standard - Safety Requirements for Medical Electrical SystemsEN 60601-1-2:2015Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and testsEN 60601-1-4:2004M

4、edical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical SystemsEN 60601-1-6:2010 + A1:2015Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: UsabilityEN 606

5、01-1-8:2007+A11:2017Part 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 systemsEN ISO 10993-1:2009Biological evaluation of medical devices Part

6、 1: Evaluation and testing within a risk management processEN 62366-1:2015Medical devices Application of usability engineering to medical devicesEN 60601-1-11:2015Medical Electrical Equipment Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements

7、 for medical electrical equipment and medical electrical systems used in the home healthcare environmentEN ISO 80601-2-55:2011Medical Electrical Equipment Part 2-55: Particular requirements for basic safety and essential performance of respiratory gas monitorsEN ISO 80601-2-72:2015Medical Electrical

8、 Equipment Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator dependent patients.EN ISO 5356-1:2015Anesthetic and respiratory equipment Conical connectors. Part 1: Cones and socketsEN 62304:2006 + A1:2015Medical dev

9、ice software Software life-cycle processPuritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QPage 1 of 56Essential Requirements MatrixOTHER STANDARDSPart ANote: Part A of this document lists the Essential Requirements from Annex I of the Medical Device Directive 93/42/E

10、EC, as amended by 2007/47/EC.Template 10060771, Rev.202I. General Requirements1.The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and

11、 health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. This shall include:YEN I

12、SO 13485EN ISO 14971EN 60601-1IEC 60601-1-9ISO Certificate (Document Number: 10069298)PB560 Risk Management File (Document Number: 10035448)Power Pack Risk Management FileSTANDARD NUMBER/REVISIONNON-HARMONIZED STANDARD DESCRIPTIONIEC62133:2012Secondary cells and batteries containing alkaline or othe

13、r non-acid electrolytes Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applicationsISO 18562-1:2017Biocompatibility evaluation of breathing gas pathways in healthcare applicationsIEC 60601-1-9: 2007 +A1: 2013General requirements for bas

14、ic safety and essential performance Collateral Standard: Requirements for environmentally conscious design (clauses 4.1, 4.5.2 and 4.5.3).MEDDEV 2.7.1 Rev 4Clinical Evaluation: A guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EECMEDDEV 2.12/2 Rev 2Guidelines on med

15、ical devices. Post Market Clinical Follow-up StudiesSTANDARD NUMBER/REVISIONHARMONIZED STANDARD DESCRIPTIONISTA 2A:2011Testing of individual packaged-products weighing 150 lb (68kg) or less when prepared for shipment.Essential Requirement/PrincipleApply (Y/N)Harmonized Medical Device Standards Appli

16、edOther non-Harmonized Standards or Local/Corporate Procedures AppliedEvidence of compliance or reason for non-applicability(and document location, if applicable)Puritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requirements MatrixPage 2 of 56Template 10060

17、771, Rev.202 reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), andIEC 60601-1EN ISO 80601-2-72EN 62366-1EN 60601-1-6IEC 60601-1-6EN 60601-1-2(Document Number: 100

18、63856)PB560 TRF for general standard - EN ISO 60601-1 (Document Number: RE00188736)PB560 TRF for homecare particular - EN ISO 80601-2- 72 (Document number: RE00188741)PB560 Usability TRF (EN 60601-1-6) (Document Number: RE00188738)PB560 usability reports (Document Numbers RE00171568 & RE00171570)PB5

19、60 EMC 4th Edition TRF (EN 60601-1-2) (Document Number RE00188737)PB560 EMC (4th Edition) Test Report for 560 Series (Document Number: RE00175424)PB560 IEC 60601-1-9Compliance AssessmentEssential Requirement/PrincipleApply (Y/N)Harmonized Medical Device Standards AppliedOther non-Harmonized Standard

20、s or Local/Corporate Procedures AppliedEvidence of compliance or reason for non-applicability(and document location, if applicable)Puritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requirements MatrixPage 3 of 56Template 10060771, Rev.202(Document Number: R

21、E00182420) consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).YEN ISO 13485N/AClinical evaluation for Puritan Bennett 560/520 (Document Number:

22、 10054043)PB560 Risk Management File (Document Number: 10035448)Power Pack Risk Management File (Document Number: 10063856)COMMENTS N/A2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknow

23、ledged state of the art.In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: eliminate or reduce risks as far as possible (inherently safe design and construction),YEN ISO 14971EN 60601-1IEC 60601-1N/APB560 Risk Management File (Do

24、cument Number: 10035448)Power Pack Risk Management File (Document Number: 10063856)Essential Requirement/PrincipleApply (Y/N)Harmonized Medical Device Standards AppliedOther non-Harmonized Standards or Local/Corporate Procedures AppliedEvidence of compliance or reason for non-applicability(and docum

25、ent location, if applicable)Puritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requirements MatrixPage 4 of 56Template 10060771, Rev.202EN 60601-1-2PB560 TRF for general standard - EN ISO 60601-1 (Document Number: RE00188736)EMC 4th Edition TRF (EN 60601-1-2

26、) (Document Number RE00188737)4th Edition EMC Test Report for 560 Series (Document Number: RE00175424) where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,YEN ISO 14971EN ISO 80601-2-72N/APB560 TRF for general standard - E

27、N ISO 60601-1 (Document Number: RE00188736)PB560 Risk Management File (Document Number: 10035448)Power Pack Risk Management File (Document Number: 10063856)PB560 TRF for homecare particular - EN ISO 80601-2- 72 Document Number: RE00188741)Essential Requirement/PrincipleApply (Y/N)Harmonized Medical

28、Device Standards AppliedOther non-Harmonized Standards or Local/Corporate Procedures AppliedEvidence of compliance or reason for non-applicability(and document location, if applicable)Puritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requirements MatrixPage

29、 5 of 56Template 10060771, Rev.202EN 60601-1-8PB560 Labeling Validation Report (Document Number: RE00207887)PB560 TRF for alarms standards EN 60601-1-8 (Document Number: RE00188739)PB560 User manual,Clinicians Manual andPowerpack Users Manual(Manual BOM:RE00207625) inform users of the residual risks

30、 due to any shortcomings of the protection measures adopted.YEN ISO 14971EN ISO 80601-2-72N/APB560 Risk Management File (Document Number: 10035448)Power Pack Risk Management File (Document Number: 10063856)PB560 Labeling Validation Report (Document Number: RE00207887)PB560 TRF for homecare particula

31、r - EN ISO 80601-2- 72 Document Number: RE00188741)Essential Requirement/PrincipleApply (Y/N)Harmonized Medical Device Standards AppliedOther non-Harmonized Standards or Local/Corporate Procedures AppliedEvidence of compliance or reason for non-applicability(and document location, if applicable)Puri

32、tan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requirements MatrixPage 6 of 56Template 10060771, Rev.202PB560 User manual,Clinicians Manual andPowerpack Users Manual(Manual BOM:RE00207625)COMMENTS3. The devices must achieve the performances intended by the m

33、anufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer.YEN ISO 80601-2-72N/APB560 TRF for homecare particular - EN ISO 80601-2- 72 Document Number: RE00188741)COMM

34、ENTS4. The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufac

35、turer, when the device is subjected to the stresses which can occur during normal conditions of use.YEN 60601-1IEC 60601-1N/APB560 TRF for general standard - EN ISO 60601-1 (Document Number: RE00188736)PB560 Risk Management File (Document Number: 10035448)Essential Requirement/PrincipleApply (Y/N)Ha

36、rmonized Medical Device Standards AppliedOther non-Harmonized Standards or Local/Corporate Procedures AppliedEvidence of compliance or reason for non-applicability(and document location, if applicable)Puritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requir

37、ements MatrixPage 7 of 56Template 10060771, Rev.202EN ISO 80601-2-72EN 60601-1-4EN 62304Power Pack Risk Management File (Document Number: 10063856)PB560 TRF for homecare particular - EN ISO 80601-2- 72 Document Number: RE00188741)PB560 User manual,Clinicians Manual andPowerpack Users Manual(Manual B

38、OM:RE00207625)PB520/PB560 Series Ventilator Gap Analysis Report against IEC 62304:2006 + A1:2015 (RE00152400)PB560 Software TRF EN 62304 (Document number: RE00188743)COMMENTSEssential Requirement/PrincipleApply (Y/N)Harmonized Medical Device Standards AppliedOther non-Harmonized Standards or Local/C

39、orporate Procedures AppliedEvidence of compliance or reason for non-applicability(and document location, if applicable)Puritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requirements MatrixPage 8 of 56Template 10060771, Rev.2025. The devices must be designed

40、, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer.YEN ISO 80601-2-72ISTA 2APB560 Risk Management Fil

41、e (Document Number: 10035448)Power Pack Risk Management File (Document Number: 10063856)PB560 Package Validation Test Report (Document Number: 10053462)Power Packaging Validation Report (Document Number: 10076450)PB560 TRF for homecare particular - EN ISO 80601-2- 72 Document Number: RE00188741)6. A

42、ny undesirable side-effect must constitute an acceptable risk when weighed against the performances intended.YEN ISO 14971N/APB560 Risk Management File (Document Number: 10035448)Power Pack Risk Management File (Document Number: 10063856)Essential Requirement/PrincipleApply (Y/N)Harmonized Medical D

43、evice Standards AppliedOther non-Harmonized Standards or Local/Corporate Procedures AppliedEvidence of compliance or reason for non-applicability(and document location, if applicable)Puritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requirements MatrixPage

44、9 of 56Template 10060771, Rev.202PB560 TRF for general standard - EN ISO 60601-1 (Document Number: RE00188736)6a. Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.YN/AMEDDEV 2.7.1 MEDDEV 2.12/2Clinical evaluation for Puritan Be

45、nnett 560/520 (Document Number: 10054043)COMMENTSII. Requirements Regarding Design and Construction7. Chemical, physical and biological properties7.1. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the Gene

46、ral requirements. Particular attention must be paid to: the choice of materials used, particularly as regards toxicity and, where appropriate, flammability,YEN ISO 80601-2-72EN ISO 10993-1ISO 18562-1EN ISO 14971N/APB560 TRF for homecare particular - EN ISO 80601-2- 72 Document Number: RE00188741)PB5

47、00 Series Biocompatibility Test Report (Document Number RE00165028)PB560 Risk Management File (Document Number: 10035448)Essential Requirement/PrincipleApply (Y/N)Harmonized Medical Device Standards AppliedOther non-Harmonized Standards or Local/Corporate Procedures AppliedEvidence of compliance or

48、reason for non-applicability(and document location, if applicable)Puritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requirements MatrixPage 10 of 56Template 10060771, Rev.202 the compatibility between the materials used and biological tissues, cells and bod

49、y fluids, taking account of the intended purpose of the device.YEN ISO 10993-1ISO 18562-1N/APB500 Series Biocompatibility Test Report (Document Number RE00165028) where appropriate, the results of biophysical or modeling research whose validity has been demonstrated beforehand.NN/AN/AThis essential

50、requirement is not appropriate and does not apply to the device.The device itself does not have physical contact with the patient, therefore, there was no biophysical or modeling research that was performed.7.2. The devices must be designed, manufactured and packed in such a way as to minimize the r

51、isk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure.YEN ISO 8

52、0601-2-72EN ISO 14971N/APB560 TRF for homecare particular - EN ISO 80601-2- 72 Document Number: RE00188741)PB560 Risk Management File (Document Number: 10035448)Power Pack Risk Management FileEssential Requirement/PrincipleApply (Y/N)Harmonized Medical Device Standards AppliedOther non-Harmonized St

53、andards or Local/Corporate Procedures AppliedEvidence of compliance or reason for non-applicability(and document location, if applicable)Puritan Bennett TM 560 Ventilator and optional Power PackDOCUMENT #: 10053865REV: QEssential Requirements MatrixPage 11 of 56Template 10060771, Rev.202(Document Nu

54、mber: 10063856)7.3. The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during their normal use or during routine procedures; if the devices are intended to administer medicinal products

55、they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these products and that their performance is maintained in accordance with the intended use.YEN ISO 10993-1ISO 18562-1N/APB500 Series Biocompatibility Test Report (Document Number RE00165028)7.4. Where a device incorporates, as an integral part, a substance which, if used sepa