DIN EN ISO 11979-6:2015-02

Действует

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) — 19 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

PD ISO/TR 22979:2006

Заменен

Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications — 26 стр.

ÖNORM EN ISO 10993-5:2009-12

Действует

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

ÖNORM EN ISO 8318:2003-01

Действует

Packaging - Complete, filled transport packages and unit loads - Sinusoidal vibration tests using a variable frequency (ISO 8318:2000)

DIN ISO 2248:1988-06

Отменен

Packaging; complete, filled transport packages; vertical impact test by droping; identical with ISO 2248:1985 — 4 стр.

ASTM F1929-98

Заменен

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration — 3 стр.

DIN EN ISO 14971:2013-04

Отменен

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012 — 112 стр.

DIN EN ISO 11979-10:2014-12

Отменен

Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006 + Amd.1:2014); German version EN ISO 11979-10:2006 + A1:2014 — 26 стр.

DIN EN ISO 11979-9:2014-12

Отменен

Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006 + Amd.1:2014); German version EN ISO 11979-9:2006 + A1:2014 — 24 стр.

DIN EN ISO 11979-8:2011-09

Отменен

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2009 + A1:2011 — 13 стр.

DIN EN ISO 11979-7:2014-12

Отменен

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014); German version EN ISO 11979-7:2014 — 52 стр.

DIN EN ISO 11979-5:2010-11

Отменен

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006); German version EN ISO 11979-5:2006 — 34 стр.

DIN EN ISO 11979-4:2013-01

Действует

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008 + Amd.1:2012); German version EN ISO 11979-4:2008 + A1:2012 — 14 стр.

DIN EN ISO 11979-3:2013-04

Действует

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012); German version EN ISO 11979-3:2012 — 35 стр.

DIN EN ISO 11979-2:2014-12

Действует

Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014); German version EN ISO 11979-2:2014 — 34 стр.

DIN EN ISO 11979-1:2013-01

Отменен

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012); German version EN ISO 11979-1:2012 — 22 стр.

DIN EN ISO 11607-2:2014-11

Отменен

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014); German version EN ISO 11607-2:2006 + A1:2014 — 21 стр.

DIN EN ISO 11607-1:2014-11

Отменен

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014 — 45 стр.

DIN EN ISO 10993-12:2012-10

Действует

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012 — 33 стр.

DIN EN ISO 10993-5:2009-10

Действует

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009 — 46 стр.

DIN EN ISO 8318:2002-12

Действует

Packaging - Complete, filled transport packages and unit loads - Sinusoidal vibration tests using a variable frequency (ISO 8318:2000); German version EN ISO 8318:2002 — 10 стр.

DIN EN ISO 2233:2001-11

Действует

Packaging - Complete, filled transport packages and unit loads - Conditioning for testing (ISO 2233:2000); German version EN ISO 2233:2001 — 6 стр.

DIN EN 22248:1993-02

Действует

Packaging; complete, filled transport packages; vertical impact test by dropping (ISO 2248:1985); german version EN 22248:1992 — 4 стр.

DIN EN ISO 11979-6:2013-05

Отменен

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO/DIS 11979-6:2013); German version prEN ISO 11979-6:2013

DIN EN ISO 11979-6:2007-11

Отменен

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2007); German version EN ISO 11979-6:2007 — 19 стр.

На этот документ ссылаются

DIN EN ISO 11979-6:2007-11

Отменен

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2007); German version EN ISO 11979-6:2007 — 19 стр.

DIN EN ISO 11979-8:2011-09

Отменен

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2009 + A1:2011 — 13 стр.

DIN EN ISO 11979-8:2017-08

Действует

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017); German version EN ISO 11979-8:2017 — 15 стр.

DIN EN ISO 11979-8:2015-09

Отменен

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2015 — 14 стр.

DIN EN ISO 11979-1:2013-01

Отменен

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012); German version EN ISO 11979-1:2012 — 22 стр.