EN 13503-8 : 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
01-07-2006
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Safety and performance
5 Materials
6 Clinical evaluation
7 Manufacturing
8 Sterilization
9 Packaging and shelf life
10 Labelling and information
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions
of EU Directives
Defines fundamental requirements for all types of intraocular lenses (IOLs) for surgical implementation into the anterior segment of the human eye. Excludes corneal implants and transplants.
| Committee |
TC 170
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NEN EN 13503-8 : 2000 | Identical |
| NBN EN 13503-8 : 2000 | Identical |
| SN EN 13503-8 : 2000 | Identical |
| NS EN 13503-8 : 1ED 2000 | Identical |
| NF EN 13503-8 : 2000 | Identical |
| UNI EN 13503-8 : 2001 | Identical |
| BS EN 13503-8:2000 | Identical |
| I.S. EN 13503-8:2000 | Identical |
| UNE-EN 13503-8:2000 | Identical |
| DIN EN 13503-8:2000-07 | Identical |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN ISO 11979-1:2012 | Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012) |
| 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 |
| EN ISO 10993-7 : 2008 COR 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009) |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| EN ISO 11979-2:2014 | Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014) |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| EN 13503-6 : 2002 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY |
| ISO 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
| EN 13503-3 : 2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS |
| EN 13503-5 : 2001 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY |
| EN 13503-7 : 2001 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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