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BS EN ISO 11979-3:2012

Current
Current

The latest, up-to-date edition.

Ophthalmic implants. Intraocular lenses Mechanical properties and test methods
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-31-2012

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).

This part of ISO11979 specifies requirements and test methods for certain mechanical properties of intraocular lenses (IOLs).

It is applicable to all types of IOLs intended for implantation in the anterior segment of the human eye, excluding corneal implants, provided that the test method is appropriate to the particular IOL design.

Committee
CH/172/7
DevelopmentNote
Supersedes BS EN 13503-3 & 04/30103818 DC (05/2006) Supersedes 11/30218023 DC. (12/2012)
DocumentType
Standard
Pages
42
PublisherName
British Standards Institution
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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