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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

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.


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€64.00
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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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