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ÖNORM EN ISO 13408-6:2021-10

Действует

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

Описание Изменения Ссылки Версии

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 13408-7:2012

Действует

Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products — 26 стр.

ISO 14644-1:2015

Действует

Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration — 44 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 18362:2016

Действует

Manufacture of cell-based health care products -- Control of microbial risks during processing — 42 стр.

ISO 11139:2018

Действует

Sterilization of health care products -- Vocabulary of terms used in sterilization and related equipment and process standards — 56 стр.

ISO/IEC 90003:2004

Заменен

Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software — 62 стр.

ÖNORM EN ISO 13408-6:2013-12

Заменен

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

На этот документ ссылаются

ÖNORM EN ISO 13408-6:2013-12

Заменен

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