UNE-EN ISO 5840-1:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - Part 1: General requirements (ISO 5840-1:2015)
Hardcopy , PDF
Spanish, Castilian, English
02-03-2016
01-03-2021
1.1This International Standard is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of this International Standard provide specific requirements.
1.2This International Standard is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
1.3This International Standard outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
1.4This International Standard defines operational conditions for heart valve substitutes.
1.7This International Standard excludes homografts.
NOTE A rationale for the provisions of this International Standard is given in Annex A.
| Committee |
CTN 91
|
| DocumentType |
Standard
|
| Pages |
64
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| Standards | Relationship |
| ISO 5840-1:2015 | Identical |
| EN ISO 5840-1:2015 | 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 |
| 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 |
| 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 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| 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 532:1975 | Acoustics — Method for calculating loudness level |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 5840-3:2013 | Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques |
| 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 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 5840-2:2015 | Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes |
| IEC 60651:1979+AMD1:1993+AMD2:2000 CSV | Sound level meters |
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