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I.S. EN ISO 11979-3:2012

Current
Current

The latest, up-to-date edition.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2012

Publisher

National Standards Authority of Ireland

Preview

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
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Recovery of properties following simulated surgical
  manipulation
6 Additions for accommodating IOLs (AIOLs)
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) - Testing of compression force decay
Annex G (normative) - Testing of dynamic fatigue durability
Annex H (informative) - Measurement of loop pull strength
Annex I (informative) - Clearance analysis
Annex J (informative) - Precision
Bibliography

Defines requirements and test methods for certain mechanical properties of intraocular lenses (IOLs).

DevelopmentNote
Supersedes I.S. EN 13503-3. (07/2006)
DocumentType
Standard
Pages
45
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
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
ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
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
ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods

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Hardcopy - English
PDF - English
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