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ÖNORM EN ISO 13408-6:2013-12

Действует
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (consolidated version)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 13408-1:2008
Действует
Aseptic processing of health care products -- Part 1: General requirements — 54 стр.
ISO 13408-4:2005
Действует
Aseptic processing of health care products -- Part 4: Clean-in-place technologies — 22 стр.
ISO 13408-5:2006
Действует
Aseptic processing of health care products -- Part 5: Sterilization in place — 22 стр.
ISO 14644-7:2004
Действует
Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) — 60 стр.
ISO/IEC 90003:2004
Заменен
Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software — 62 стр.
ÖNORM EN ISO 13408-6:2011-09
Заменен
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

На этот документ ссылаются

DIN EN 556-2:2015-11
Действует
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 — 19 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 13408-1:2013-08
Отменен
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013); German version EN ISO 13408-1:2011 + A1:2013 — 64 стр.
DIN EN ISO 13408-1:2015-12
Действует
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015 — 70 стр.
DIN EN ISO 14534:2015-08
Действует
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015 — 23 стр.
DIN EN ISO 14534:2011-06
Отменен
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2011 — 21 стр.
DIN EN ISO 22442-1:2008-03
Отменен
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); German version EN ISO 22442-1:2007 — 36 стр.
ÖNORM EN ISO 13408-6:2011-09
Заменен
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)