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UNE-EN ISO 11979-6:2015

Current

Current

The latest, up-to-date edition.

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

13-05-2015

Committee
CTN 91
DevelopmentNote
Supersedes UNE EN 13503-6. (01/2008)
DocumentType
Standard
Pages
20
PublisherName
Asociacion Espanola de Normalizacion
Status
Current
Supersedes

ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F 1929 : 2015 : REDLINE 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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