BS EN ISO 11979-3:2012
Current
The latest, up-to-date edition.
Ophthalmic implants. Intraocular lenses Mechanical properties and test methods
Hardcopy , PDF
English
31-12-2012
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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).
| 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 |
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.
| Standards | Relationship |
| NEN EN ISO 11979-3 : 2012 | Identical |
| EN ISO 11979-3:2012 | Identical |
| ISO 11979-3:2012 | Identical |
| UNE-EN ISO 11979-3:2013 | Identical |
| NS EN ISO 11979-3 : 2012 | Identical |
| DIN EN ISO 11979-3:2013-04 | Identical |
| NBN EN ISO 11979-3 : 2013 | Identical |
| SN EN ISO 11979-3:2013 | Identical |
| I.S. EN ISO 11979-3:2012 | Identical |
| NF EN ISO 11979-3 : 2013 | Identical |
| UNI EN ISO 11979-3 : 2013 | Identical |
| 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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