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BS EN ISO 5840:2009

BS EN ISO 5840:2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s)

Hardcopy , PDF

Superseded date

10-31-2015

Language(s)

English

Published date

10-31-2009

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Verification testing and analysis/Design validation
Annex A (informative) - Rationale for the provisions of
                        this International Standard
Annex B (informative) - Heart valve substitute hazards,
                        associated failure modes and
                        evaluation methods
Annex C (informative) - Risk assessment guidelines
Annex D (informative) - Examples and definitions of
                        some physical and material
                        properties of heart valve
                        substitutes and their components
Annex E (informative) - Statistical procedures when using
                        performance criteria
Annex F (informative) - In vitro procedures for testing
                        unstented or similar valves in
                        compliant chambers
Annex G (informative) - Preclinical in vivo tests
Annex H (informative) - Echocardiographic protocol
Annex I (informative) - Description of the heart valve
                        substitute
Annex J (informative) - Figures of examples of components
                        of some heart valve substitutes
Annex K (informative) - Examples of standards applicable
                        to testing of materials and components
                        of some heart valve substitutes
Annex L (informative) - Guidelines for verification of
                        hydrodynamic performance
Annex M (informative) - Durability testing
Annex N (informative) - Examples of design specific testing
Annex O (informative) - Fatigue assessment
Annex P (normative) - Packaging
Annex Q (normative) - Labelling and instructions for use
Annex R (normative) - Methods of evaluating clinical data
Annex S (normative) - Sterilization
Bibliography
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC

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

Committee
CH/150/2
DevelopmentNote
Supersedes BS 6444-1(1990), BS EN 12006-1 and 03/103026 DC. (12/2006)
DocumentType
Standard
Pages
96
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
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
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 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 14630:2012 Non-active surgical implants General requirements
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11607:2003 Packaging for terminally sterilized medical devices
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 14971:2007 Medical devices Application of risk management to medical devices
MIL-STD-1629 Revision A:1980 PROCEDURES FOR PERFORMING A FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV Sound level meters
EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING

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PDF - English
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