Каталог стандартов

+7 (495) 223-46-76 +7 (812) 309-78-59
inform@normdocs.ru
О компании Стандарты Контакты Заказать стандарт
СтандартыON

ÖNORM EN ISO 10993-6:2009-09

Заменен
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 10993-2:2006
Действует
Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.
ISO 10993-11:2006
Заменен
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.
ISO 10993-12:2012
Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.
ISO 10993-16:2010
Заменен
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables — 18 стр.
ÖNORM EN ISO 10993-6:2017-06
Действует
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

На этот документ ссылаются

DIN EN ISO 25539-2:2009-08
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008); German version EN ISO 25539-2:2009 — 124 стр.
DIN ISO 13022:2014-06
Действует
Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012) — 62 стр.
DIN EN ISO 7405:2009-06
Отменен
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008); German version EN ISO 7405:2008 — 44 стр.
DIN EN ISO 10993-10:2009-08
Отменен
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); German version EN ISO 10993-10:2009 — 68 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 14155-1:2009-11
Отменен
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2009 — 32 стр.
DIN EN ISO 14155-2:2009-11
Отменен
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009 — 17 стр.
DIN EN ISO 15747:2010-08
Отменен
Plastic containers for intravenous injections (ISO 15747:2010); German version EN ISO 15747:2010 — 22 стр.
DIN EN ISO 15798:2010-06
Отменен
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010); German version EN ISO 15798:2010 — 27 стр.
ÖNORM EN 455-3:2007-03
Заменен
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
ÖVE/ÖNORM EN 60601-1:2014-02
Действует
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)
ÖNORM EN ISO 10993-6:2017-06
Действует
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)