I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
10-22-2015
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
6.1 Intended use
6.2 Design inputs
6.2.1 Operational specifications
6.2.2 Performance specifications
6.2.3 Packaging, labelling, and sterilization
6.3 Design outputs
6.3.1 General
6.3.2 Examples of components of some heart valve substitutes
6.4 Design transfer (manufacturing qualification)
6.5 Risk management
6.5.1 Hazard identification
6.5.2 Failure mode identification
6.5.3 Risk estimation
6.5.4 Risk evaluation
6.5.5 Risk control
6.5.6 Risk review
7 Verification testing and analysis/Design validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 Test conditions, sample selection and reporting
requirements
7.2.2 Material property assessment
7.2.3 Hydrodynamic performance assessment
7.2.4 Structural performance assessment
7.3 Preclinical in vivo evaluation
7.3.1 Overall requirements
7.3.2 Methods
7.3.3 Test report
7.4 Clinical investigation
7.4.1 Principle
7.4.2 General
7.4.3 Number of institutions
7.4.4 Number of patients
7.4.5 Duration of the study
7.4.6 Clinical data requirements
7.4.7 Clinical investigation report
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
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography
Applies to all devices intended for implantation in human hearts, as a heart valve substitute.
| DevelopmentNote |
Supersedes I.S. EN 12006-1. (03/2006)
|
| DocumentType |
Standard
|
| Pages |
100
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 5840:2009 | Identical |
| UNI EN ISO 5840 : 2009 | Identical |
| BS EN ISO 5840:2009 | Identical |
| NF EN ISO 5840 : OCT 2009 | Identical |
| NS EN ISO 5840 : 2009 | Identical |
| NEN EN ISO 5840 : 2009 | Identical |
| ISO 5840:2005 | Identical |
| DIN EN ISO 5840:2009-08 | Identical |
| NBN 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/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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