ONORM EN ISO 14630 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
12-01-2013
16-04-2025
Diese Norm legt allgemeine Anforderungen für nichtaktive chirurgische Implantate fest. In bezug auf die Sicherheit legt sie Anforderungen für die vorgesehene Leistung, Konstruktionsmerkmale, Werkstoffe, Prüfung der Konstruktion, Herstellung und Kontrolle, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller fest.
| Committee |
TC 179
|
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 14630:2012 | Identical |
| NBN EN ISO 14630 : 2013 | Identical |
| NEN EN ISO 14630 : 2012 | Identical |
| BS EN ISO 14630:2012 | Identical |
| DIN EN ISO 14630:2013-03 | Identical |
| I.S. EN ISO 14630:2012 | Identical |
| EN ISO 14630:2012 | Identical |
| NF EN ISO 14630 : 2013 | Identical |
| NS EN ISO 14630 : 2012 | Identical |
| UNE-EN ISO 14630:2013 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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 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 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| ISO 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 8601:2004 | Data elements and interchange formats — Information interchange — Representation of dates and times |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| 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 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 17664:2017 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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