I.S. EN ISO 11979-3:2012
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
Hardcopy , PDF
English
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.
Dates of withdrawal of national standards are available from NSAI.
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 |
| Standards | Relationship |
| EN ISO 11979-3:2012 | Identical |
| ISO 11979-3:2012 | Identical |
| NEN EN ISO 11979-3 : 2012 | Identical |
| NS EN ISO 11979-3 : 2012 | Identical |
| DIN EN ISO 11979-3:2013-04 | Identical |
| BS EN ISO 11979-3:2012 | Identical |
| NBN EN ISO 11979-3 : 2013 | Identical |
| NF EN ISO 11979-3 : 2013 | Identical |
| UNE-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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