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.

Описание Изменения Ссылки Версии

Ссылочные документы

DIN EN ISO 10993-5:2007-06

Отменен

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO/DIS 10993-5:2007); German version prEN ISO 10993-5:2007

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 11607-1:2006-07

Отменен

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2006 — 33 стр.

DIN EN ISO 11607-2:2006-07

Отменен

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006 — 18 стр.

DIN EN ISO 11979-1:2006-10

Отменен

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2006); German version EN ISO 11979-1:2006 — 16 стр.

DIN EN ISO 11979-2:2000-07

Отменен

Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:1999); German version EN ISO 11979-2:1999 — 15 стр.

DIN EN ISO 11979-3:2006-07

Отменен

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2006); German version EN ISO 11979-3:2006 — 39 стр.

DIN EN ISO 11979-4:2000-09

Отменен

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2000); German version EN ISO 11979-4:2000 — 7 стр.

DIN EN ISO 11979-5:2006-09

Отменен

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006); German version EN ISO 11979-5:2006 — 32 стр.

DIN EN ISO 11979-7:2006-07

Отменен

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006); German version EN ISO 11979-7:2006 — 24 стр.

DIN EN ISO 11979-8:2006-10

Отменен

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006); German version EN ISO 11979-8:2006 — 13 стр.

DIN EN ISO 11979-9:2006-12

Отменен

Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006); German version EN ISO 11979-9:2006 — 29 стр.

DIN EN ISO 11979-10:2006-11

Отменен

Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006); German version EN ISO 11979-10:2006 — 25 стр.

DIN EN ISO 14971:2007-07

Отменен

Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007 — 99 стр.

ASTM F1585-00

Отменен

Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006) — 3 стр.

ASTM F1929-98

Заменен

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration — 3 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 ISO 2248:1988-06

Отменен

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

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)

ÖNORM EN ISO 10993-5:2009-12

Действует

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

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 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 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.

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.

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.

DIN EN 13503-6:2003-03

Отменен

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2002, modified); German version EN 13503-6:2002 — 18 стр.

На этот документ ссылаются

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.

DIN EN 13503-6:2003-03

Отменен

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2002, modified); German version EN 13503-6:2002 — 18 стр.

DIN EN 13503-8:2000-07

Отменен

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:1999, modified); German version EN 13503-8:2000 — 7 стр.

DIN EN ISO 11979-4:2009-03

Отменен

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008); German version EN ISO 11979-4:2008 — 12 стр.

DIN EN ISO 11979-3:2006-07

Отменен

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2006); German version EN ISO 11979-3:2006 — 39 стр.

DIN EN ISO 11979-8:2006-10

Отменен

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006); German version EN ISO 11979-8:2006 — 13 стр.

DIN EN ISO 11979-5:2006-09

Отменен

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006); German version EN ISO 11979-5:2006 — 32 стр.

DIN EN ISO 11979-7:2006-07

Отменен

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006); German version EN ISO 11979-7:2006 — 24 стр.

DIN EN ISO 11979-7:2012-05

Отменен

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2006 + Amd 1:2012); German version EN ISO 11979-7:2006 + A1:2012 — 24 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 11979-8:2011-09

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 11979-8:2009-08

Отменен

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006); German version EN ISO 11979-8:2009 — 12 стр.

DIN EN ISO 11979-7:2012-07

Отменен

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO/DIS 11979-7:2012); German version prEN ISO 11979-7:2012 — 24 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 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.