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CEN
EN 13503-3 : 2000

EN 13503-3 : 2000

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS

Superseded date

01-05-2006

Superseded by

EN ISO 11979-3:2012

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General
  4.2 Tolerances and dimensions
  4.3 Compression force
  4.4 Axial displacement in compression
  4.5 Optic decentration
  4.6 Optic tilt
  4.7 Angle of contact
  4.8 Compression force decay
  4.9 Dynamic fatigue durability
  4.10 Loop strength
  4.11 Surface and bulk homogeneity
5 Supplementary information available from the manufacturer
Annex A (normative) Measurement of compression force
Annex B (normative) Measurement of axial displacement in
        compression
Annex C (normative) Measurement of optic decentration
Annex D (normative) Measurement of optic tilt
Annex E (normative) Measurement of angle of contact
Annex F (normative) Measurement of compression force decay
Annex G (normative) Testing of dynamic fatigue durability
Annex H (informative) Measurement of loop pull strength
Bibliography

Defines test methods and requirements for certain mechanical properties of intraocular lenses (IOLs). Applies to all types of IOLs which are intended for implantation in the anterior segnmetn of the human eye, not including corneal implants, providing the test method is appropriate to the particular design.

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Superseded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
EN 13503-7 : 2001 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
DIN EN 13503-6:2003-03 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
BS EN 13503-8:2000 Ophthalmic implants. Intraocular lenses Fundamental requirements
BS EN 13503-5:2001 Ophthalmic implants. Intraocular lenses Biocompatibility
BS EN 13503-7:2002 Ophthalmic implants. Intraocular lenses Clinical investigations
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 13503-5 : 2001 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY

ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
EN ISO 11979-1:2012 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)
ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method
EN ISO 11979-2:2014 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO 5725:1986 Precision of test methods Determination of repeatability and reproducibility for a standard test method by inter-laboratory tests
EN 13503-7 : 2001 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS

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