ISO 11979-6:2014
Current
The latest, up-to-date edition.
Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
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English, French
24-09-2014
ISO 11979-6:2014 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.
Committee |
ISO/TC 172/SC 7
|
DevelopmentNote |
Supersedes ISO/DIS 11979-6. (09/2014)
|
DocumentType |
Standard
|
Pages |
11
|
PublisherName |
International Organization for Standardization
|
Status |
Current
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Supersedes |
Standards | Relationship |
DIN EN ISO 11979-6:2015-02 | Identical |
NF EN ISO 11979-6 : 2014 | Identical |
UNE-EN ISO 11979-6:2015 | Identical |
NBN EN ISO 11979-6 : 2014 | Identical |
NEN EN ISO 11979-6 : 2014 | Identical |
NS EN ISO 11979-6 : 2014 | Identical |
I.S. EN ISO 11979-6:2014 | Identical |
PN EN ISO 11979-6 : 2015 | Identical |
SN EN ISO 11979-6 : 2014 | Identical |
UNI EN ISO 11979-6 : 2015 | Identical |
SS-EN ISO 11979-6:2014 | Identical |
BS EN ISO 11979-6:2014 | Identical |
EN ISO 11979-6:2014 | Identical |
DIN EN ISO 11979-6 E : 2015 | Identical |
UNE-EN 13503-6:2003 | Identical |
DIN EN 13503-6:2003-03 | Corresponds |
BIS IS/ISO 11979-6 : 2007 | Identical |
EN 13503-6 : 2002 | Identical |
I.S. EN 13503-6:2002 | Identical |
BIS IS/ISO 11979-8 : 2006 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
EN ISO 11979-8:2017 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017) |
ANSI Z80.27 : 2014 | OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES |
ANSI Z80.13 : 2007 | OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
I.S. EN ISO 11979-10:2007 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES (ISO 11979-10:2018) |
EN ISO 11979-10:2018 | Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018) |
DIN EN ISO 11979-8 E : 2015 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
I.S. EN ISO 11979-8:2017 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
PD ISO/TR 22979:2017 | Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
17/30335550 DC : 0 | BS EN ISO 11979-10 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES |
16/30337200 DC : 0 | BS EN ISO 11979-8 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
ANSI Z80.13 : 2007 : R2017 | OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
ISO/TR 22979:2017 | Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
ISO 11979-8:2017 | Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements |
DIN EN ISO 11979-8:2016-04 (Draft) | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
UNE-EN ISO 11979-8:2017 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017) |
ANSI Z80.30 : 2010 | OPHTHALMICS - TORIC INTRAOCULAR LENSES |
ANSI Z80.13 : 2007 : R2012 | OPHTHALMICS - PHAKIC INTRAOCULAR LENSES |
ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
ASTM F 1929 : 2012 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
ISO 2233:2000 | Packaging Complete, filled transport packages and unit loads Conditioning for testing |
ISO/TR 22979:2017 | Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
ISO 2248:1985 | Packaging Complete, filled transport packages Vertical impact test by dropping |
ISO 8318:2000 | Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency |
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