I.S. EN 13503-3:2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
Hardcopy , PDF
21-07-2006
English
01-01-2000
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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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Tolerances and dimensions
4.3 Compression force
4.4 Axial displacement in compression
4.5 Optic decentration
4.6 Optic tilt
4.7 Angle of contact
4.8 Compression force decay
4.9 Dynamic fatigue durability
4.10 Loop strength
4.11 Surface and bulk homogeneity
5 Supplementary information available from the manufacturer
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) Measurement of compression force decay
Annex G (normative) Testing of dynamic fatigue durability
Annex H (informative) Measurement of loop pull strength
Bibliography
Defines test methods and requirements for certain mechanical properties of intraocular lenses (IOLs). Applies to all types of IOLs which are intended for implantation in the anterior segment of the human eye, not including corneal implants, providing the test method is appropriate to the particular design.
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNI EN 13503-3 : 2001 | Identical |
| SN EN 13503-3 : 2000 | Identical |
| BS EN 13503-3:2000 | Identical |
| NBN EN 13503-3 : 2000 | Identical |
| EN 13503-3 : 2000 | Identical |
| ISO 11979-3:2012 | Identical |
| NEN EN 13503-3 : 2000 | Identical |
| NF EN 13503-3 : 2000 | Identical |
| NS EN 13503-3 : 1ED 2000 | Identical |
| UNE-EN 13503-3:2001 | Identical |
| DIN EN 13503-3:2000-09 | Identical |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| EN ISO 11979-1:2012 | Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012) |
| 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 |
| EN ISO 11979-2:2014 | Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014) |
| 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 |
| EN 13503-7 : 2001 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS |
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