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BS EN ISO 5840-2:2015

BS EN ISO 5840-2:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes

Available format(s)

Hardcopy , PDF

Superseded date

02-08-2021

Language(s)

English

Published date

10-31-2015

Publisher

British Standards Institution

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) - Heart valve substitute hazards,
        associated failure modes, and evaluation methods
Annex B (informative) - In vitro procedures for testing
        unstented or similar valves in compliant chambers
Annex C (informative) - Preclinical in vivo evaluation
Annex D (informative) - Description of the surgical heart
        valve substitute
Annex E (informative) - Examples of components of some
        surgical heart valve substitutes
Annex F (informative) - Guidelines for verification of
        hydrodynamic performance
Annex G (informative) - Durability testing
Annex H (informative) - Examples of design specific testing
Annex I (informative) - Fatigue assessment
Annex J (normative) - Methods of evaluating clinical data
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on medical devices

Pertains to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.

Committee
CH/150/2
DevelopmentNote
Supersedes BS EN ISO 5840 and 14/30281560 DC. (10/2015)
DocumentType
Standard
Pages
66
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 5840-2:2015 Identical
EN ISO 5840-2:2015 Identical

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
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
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 5840-1:2015 Cardiovascular implants Cardiac valve prostheses Part 1: General requirements
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to 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 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 532:1975 Acoustics Method for calculating loudness level
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV Sound level meters
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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Hardcopy - English
PDF - English
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