ISO 16672:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Ophthalmic implants Ocular endotamponades
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
29-06-2020
French, English
07-08-2015
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ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.
| DevelopmentNote |
Supersedes ISO/DIS 16672. (08/2015)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 16672 : 2015 | Identical |
| UNE-EN ISO 16672:2016 | Identical |
| NEN EN ISO 16672 : 2015 | Identical |
| NS EN ISO 16672 : 2003 | Identical |
| I.S. EN ISO 16672:2015 | Identical |
| PN EN ISO 16672 : 2015 | Identical |
| SN EN ISO 16672 : 2016 | Identical |
| UNI EN ISO 16672 : 2003 | Identical |
| SS-EN ISO 16672 : 2015 | Identical |
| UNI EN ISO 16672:2015 | Identical |
| EN ISO 16672:2015 | Identical |
| BS EN ISO 16672:2015 | Identical |
| NF EN ISO 16672 : 2015 | Identical |
| DIN EN ISO 16672:2015-12 | Identical |
| ONORM EN ISO 16672 : 2015 | 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 |
| EN ISO 10993-2:2006 | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006) |
| EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| 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 14630:2012 | Non-active surgical implants — General requirements |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| 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 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
| 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 |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
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