BS EN ISO 5840:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Cardiovascular implants. Cardiac valve prostheses
Hardcopy , PDF
10-31-2015
English
10-31-2009
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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Superseded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 |
| Standards | Relationship |
| NF EN ISO 5840 : OCT 2009 | Identical |
| DIN EN ISO 5840:2009-08 | Identical |
| NBN EN ISO 5840 : 2009 | Identical |
| EN ISO 5840:2009 | Identical |
| UNI EN ISO 5840 : 2009 | Identical |
| NS EN ISO 5840 : 2009 | Identical |
| NEN EN ISO 5840 : 2009 | Identical |
| ISO 5840:2005 | Identical |
| I.S. EN ISO 5840:2009 | Identical |
| SN EN ISO 5840 : 2009 | Identical |
| UNE-EN ISO 5840:2009 | Identical |
| 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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