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I.S. EN 13503-3:2000

Superseded

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

Available format(s)

Hardcopy , PDF

Superseded date

21-07-2006

Language(s)

English

Published date

01-01-2000

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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 segment of the human eye, not including corneal implants, providing the test method is appropriate to the particular design.

DocumentType	Standard
Pages	40
PublisherName	National Standards Authority of Ireland
Status	Superseded
SupersededBy	I.S. EN ISO 11979-3:2006

Standards	Relationship
UNI EN 13503-3 : 2001	Identical
SN EN 13503-3 : 2000	Identical
BS EN 13503-3:2000	Identical
NBN EN 13503-3 : 2000	Identical
EN 13503-3 : 2000	Identical
ISO 11979-3:2012	Identical
NEN EN 13503-3 : 2000	Identical
NF EN 13503-3 : 2000	Identical
NS EN 13503-3 : 1ED 2000	Identical
UNE-EN 13503-3:2001	Identical
DIN EN 13503-3:2000-09	Identical

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)
EN ISO 11979-4:2008/A1:2012	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008/AMD 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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I.S. EN 13503-3:2000

Superseded

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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