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ANSI/AAMI/ISO 5840-3:2013

Current
Current

The latest, up-to-date edition.

CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-12-2012

Glossary of equivalent standards
Committee representation
Background
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 part of ISO 5840
Annex B (informative) - Examples of transcatheter
        heart valve substitutes, components and
        delivery systems
Annex C (normative) - Packaging
Annex D (normative) - Product labels, instructions
        for use and training
Annex E (normative) - Sterilization
Annex F (informative) - Valve description
Annex G (informative) - Transcatheter heart valve
        substitute hazards, associated failure modes
        and evaluation methods
Annex H (informative) - In vitro test guidelines for
        paediatric devices
Annex I (informative) - Statistical procedures when using
        performance criteria
Annex J (informative) - Examples and definitions of some
        physical and material properties of transcatheter
        heart valve substitutes and their components
Annex K (informative) - Examples of standards applicable
        to testing of materials and components of
        transcatheter heart valve substitutes
Annex L (informative) - Raw and post-conditioning mechanical
        properties for support structure materials
Annex M (informative) - Corrosion assessment
Annex N (informative) - Guidelines for verification of
        hydrodynamic performance
Annex O (informative) - Durability testing
Annex P (informative) - Fatigue assessment
Annex Q (informative) - Preclinical in vivo evaluation
Annex R (normative) - Adverse event classification during
        clinical investigation
Annex S (informative) - Echocardiographic protocol
Bibliography

Pertains to all devices intended for implantation in human hearts as a minimally invasive implanted heart valve substitute.

Committee
CV
DocumentType
Standard
ISBN
1-57020-492-6
Pages
120
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

Standards Relationship
ISO 5840-3:2013 Identical

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 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 5840:2005 Cardiovascular implants Cardiac valve prostheses
ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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 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 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 14630:2012 Non-active surgical implants General requirements
ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
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
ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
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/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
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 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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