ÖNORM EN ISO 11979-5:2021-04

Действует

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)

Ссылочные документы

ISO 10993-1:2009/Cor.1:2010

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process -- Technical Corrigendum 1 — 1 стр.

ISO 10993-2:2006

Действует

Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.

ISO 10993-3:2014

Действует

Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity — 42 стр.

ISO 10993-5:2009

Действует

Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.

ISO 10993-6:2007

Заменен

Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation — 28 стр.

ISO 10993-10:2010

Действует

Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization — 74 стр.

ISO 11979-1:2012

Заменен

Ophthalmic implants -- Intraocular lenses -- Part 1: Vocabulary — 18 стр.

ISO 11979-2:1999/Cor.1:2003

Заменен

Ophtalmic implants. Intraocular lenses. Part 2. Optical properties and test methods -- Technical Corrigendum 1 — 1 стр.

ISO 11979-3:2012

Действует

Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods — 38 стр.

ISO 14971:2007

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

ISO/TR 22979:2006

Заменен

Ophthalmic implants -- Intraocular lenses -- Guidance on assessment of the need for clinical investigation of intraocular lens design modifications — 24 стр.

ÖNORM EN ISO 11979-5:2010-11

Заменен

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)

На этот документ ссылаются

ÖNORM EN ISO 11979-5:2010-11

Заменен

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)