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16/30310949 DC : 0

NA
NA

Status of Standard is Unknown

BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
Available format(s)

Hardcopy , PDF

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Design verification testing and
  analysis/Design validation
Annex A (informative) - Rationale for the
        provisions of this International Standard
Annex B (informative) - Examples of heart valve
        repair devices and delivery systems
Annex C (normative) - Packaging
Annex D (normative) - Product labels, instructions
        for use, and training
Annex E (normative) - Sterilization
Annex F (informative) - Heart valve repair system
        characteristics
Annex G (informative) - Heart valve repair system
        hazards, associated failure modes and
        evaluation methods
Annex H (informative) - In vitro test guidelines for
        paediatric devices
Annex I (informative) - Examples and definitions of
        some physical and material properties of heart
        valve repair devices and their components
Annex J (informative) - Examples of Standards
        applicable to testing of materials and
        components of heart valve repair devices
Annex K (informative) - Considerations for device
        material properties undergoing alterations
        post implantation
Annex L (informative) - Corrosion assessment
Annex M (informative) - Guidelines for in vitro
        evaluation of functional performance
        of the repair
Annex N (informative) - Durability testing
Annex O (informative) - Fatigue assessment
Annex P (informative) - Preclinical in vivo evaluation
Annex Q (normative) - Adverse event classification
        during clinical investigation
Annex R (informative) - Imaging protocol
Annex S (informative) - Clinical investigation endpoints
        for valve repair devices: Suggestions for
        endpoints and their timing
Annex T (informative) - Additional device design
        evaluation requirements
Annex U (informative) - Guidelines for delivery
        system design evaluation testing
Bibliography

BS ISO 5910.

Committee
CH/150/2
DocumentType
Draft
Pages
125
PublisherName
British Standards Institution
Status
NA

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 5840-1:2015 Cardiovascular implants Cardiac valve prostheses Part 1: General requirements
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 14630:2012 Non-active surgical implants General requirements
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 5840-3:2013 Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 5840-2:2015 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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