Стандарты ISO

ISO 13408-1:2008

Действует

Aseptic processing of health care products -- Part 1: General requirements — 54 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

ISO 13408-1:2008/Amd.1:2013

Действует

Aseptic processing of health care products -- Part 1: General requirements -- Amendment 1 — 10 стр.

На этот документ ссылаются

BS EN ISO 14534:2011

Заменен

Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements — 20 стр.

BS ISO 13408-7:2012

Действует

Aseptic processing of health care products. Alternative processes for medical devices and combination products — 30 стр.

ISO 13408-1:2008/Amd.1:2013

Действует

Aseptic processing of health care products -- Part 1: General requirements -- Amendment 1 — 10 стр.

BS EN ISO 16061:2009

Заменен

Instrumentation for use in association with non-active surgical implants. General requirements — 28 стр.

BS EN ISO 13408-7:2015

Действует

Aseptic processing of health care products. Alternative processes for medical devices and combination products — 30 стр.

BS ISO 18362:2016

Действует

Manufacture of cell-based health care products. Control of microbial risks during processing — 46 стр.

BS EN ISO 13408-2:2018

Действует

Aseptic processing of health care products. Sterilizing filtration — 42 стр.

PD ISO/TR 20520:2018

Действует

Traditional Chinese medicine. Infection control for acupuncture treatment — 12 стр.

BS EN ISO 11139:2018

Действует

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

BS EN ISO 16671:2015+A1:2017

Действует

Ophthalmic implants. Irrigating solutions for ophthalmic surgery — 32 стр.

ÖNORM EN ISO 15798:2013-12

Заменен

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)

ÖNORM EN ISO 16671:2015-12

Заменен

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)

ÖNORM EN ISO 13408-7:2015-11

Действует

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

ÖNORM EN ISO 13408-2:2018-06

Действует

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

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)

ÖNORM EN ISO 16672:2015-12

Действует

Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)