11/30219211 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES
Hardcopy , PDF
English
30-04-2013
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) - Minimally invasive heart
valve substitute hazards, associated failure
modes and evaluation methods
Annex C (informative) - Examples and definitions of
some physical and material properties of
heart valve substitutes and their components
Annex D (informative) - Statistical procedures when
using performance criteria
Annex E (informative) - In vitro test guidelines for
paediatric devices
Annex F (informative) - Preclinical in vivo evaluation
Annex G (informative) - Echocardiographic protocol
Annex H (informative) - Valve description
Annex I (informative) - Examples of minimally invasive
heart valve substitutes, components and
delivery systems
Annex J (informative) - Examples of standards applicable
to testing of materials and components of
some heart valve substitutes
Annex K (informative) - Guidelines for verification of
hydrodynamic performance
Annex L (informative) - Durability testing
Annex M (informative) - Fatigue assessment
Annex N (normative) - Packaging
Annex O (normative) - Product labels, instructions for
use, and training
Annex P (normative) - Adverse event classification
during clinical investigation
Annex Q (normative) - Sterilization
Annex R (informative) - Raw and post-conditioning
mechanical properties
Annex S (informative) - Corrosion assessment
Bibliography
Annex ZA (informative) - Relationship between this
International Standard and the Essential
Requirements of EU Directive 93/42
BS EN ISO 5840-3
| Committee |
CH/150/2
|
| DocumentType |
Draft
|
| Pages |
112
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN ISO 5840-3 : DRAFT 2011 | 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 |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans |
| 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 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 8601:2004 | Data elements and interchange formats — Information interchange — Representation of dates and times |
| 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 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 11607:2003 | Packaging for terminally sterilized medical devices |
| 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 |
| ISO 11137:1995 | Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization |
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