UNE-EN ISO 16672:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
Hardcopy , PDF
01-11-2021
Spanish, Castilian, English
20-01-2016
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
5.1 General
5.2 Chemical and biological contaminants
5.3 Chemical description
5.4 Concentration of the components
5.5 Density
5.6 Gaseous expansion
5.7 Interfacial tension
5.8 Kinematic viscosity
5.9 Molecular mass distribution
5.10 Particulates
5.11 Refractive index
5.12 Spectral transmittance
5.13 Surface tension
5.14 Vapour pressure
6 Design evaluation
6.1 General
6.2 Evaluation of biological safety
6.3 Clinical investigation
7 Sterilization
8 Product stability
9 Integrity and performance of the delivery system
10 Packaging
10.1 Protection from damage during storage and transport
10.2 Maintenance of sterility in transit
11 Information supplied by the manufacturer
Annex A (normative) Intraocular implantation test
Annex B (informative) Clinical investigation
Bibliography
Applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
| Committee |
CTN 91
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 16672:2015 | Identical |
| NBN EN ISO 16672 : 2015 | Identical |
| NEN EN ISO 16672 : 2015 | Identical |
| NS EN ISO 16672 : 2003 | Identical |
| I.S. EN ISO 16672:2015 | Identical |
| SN EN ISO 16672 : 2016 | Identical |
| UNI EN ISO 16672 : 2003 | 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 |
| 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 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| EN ISO 10993-6:2016 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) |
| 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 |
| EN 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 11135-1:2007) |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| 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 |
| EN 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 (ISO 17665-1:2006) |
| 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 |
| EN ISO 20857:2013 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
| 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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