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CEN
EN 13503-5 : 2001

EN 13503-5 : 2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY

Superseded date

01-06-2006

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

1 Scope
2 Normative references
3 Terms and definitions
4 General requirements applying to the biological evaluation
  of intraocular lenses
5 Physicochemical tests
  5.1 General
  5.2 Test of extractables and hydrolytic stability
  5.3 Degradation tests
Annex A (normative) Test for extractables and hydrolytic
        stability
Annex B (normative) Test of photostability
Annex C (normative) Nd-YAG laser exposure test
Annex D (normative) Ocular implantation test
Annex E (informative) Selected definitions
Annex F (informative) A-deviations
Annex ZA (informative) A-deviations
Bibliography

Specifies particular requirements for the biological evaluation of intraocular lenses (IOLS) which are in addition to the requirements outlined in the relevant parts of EN ISO 10993.

Committee
TC 170
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

I.S. EN 13503-8:2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
EN 13503-8 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS
DIN EN 13503-6:2003-03 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
I.S. EN 13503-6:2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses Fundamental requirements
BS EN 13503-6:2002 Ophthalmic implants. Intraocular lenses Shelf-life and transport stability
EN 13503-6 : 2002 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY

EN ISO 11979-1:2012 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)
EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
EN 30993-6 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
EN ISO 11979-2:2014 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
EN 13503-3 : 2000 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

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