Стандарты DIN ICS 11 Health care technology / Здравоохранение 11.080 Sterilization and disinfection / Стерилизация и дезинфекция 11.080.01 Sterilization. Including sterilization methods, air quality of surgery rooms, etc. / Стерилизация и дезинфекция в целом. Включая методы стерилизации, качество воздуха в операционных и т.д.

DIN EN ISO 13408-3:2011-09

Действует

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German version EN ISO 13408-3:2011 — 22 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

DIN EN ISO 9000:2005-12

Отменен

Quality management systems - Fundamentals and vocabulary (ISO 9000:2005); Trilingual version EN ISO 9000:2005 — 68 стр.

ÖNORM EN ISO 13485:2010-02

Заменен

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor 1:2009) (consolidated version)

DIN EN ISO 9001:2008-12

Отменен

Quality management systems - Requirements (ISO 9001:2008); Trilingual version EN ISO 9001:2008 — 91 стр.

DIN EN ISO 13408-1:2011-09

Отменен

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008); German version EN ISO 13408-1:2011 — 65 стр.

DIN EN ISO 13408-4:2011-09

Действует

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version EN ISO 13408-4:2011 — 27 стр.

DIN EN ISO 13408-5:2011-09

Действует

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006); German version EN ISO 13408-5:2011 — 27 стр.

DIN EN ISO 13485:2010-01

Отменен

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009 — 75 стр.

ÖNORM EN ISO 9000:2005-12

Заменен

Quality management systems - Fundamentals and vocabulary (ISO 9000:2005) (multilingual version: de/en/fr)

DIN EN ISO 9001 Berichtigung 1:2009-12

Отменен

Quality management systems - Requirements (ISO 9001:2008); Trilingual version EN ISO 9001:2008, Corrigendum to DIN EN ISO 9001:2008-12; Trilingual version EN ISO 9001:2008/AC:2009 — 20 стр.

DIN EN 13824:2005-02

Отменен

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements; German version EN 13824:2004 — 64 стр.

DIN EN ISO 13408-3:2011-01

Отменен

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German Version FprEN ISO 13408-3:2010 — 22 стр.

На этот документ ссылаются

DIN EN ISO 22442-1:2016-05

Отменен

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version EN ISO 22442-1:2015 — 43 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 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 13408-1:2011-01

Отменен

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008); German version FprEN ISO 13408-1:2010 — 65 стр.

DIN EN ISO 13408-1:2011-09

Отменен

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008); German version EN ISO 13408-1:2011 — 65 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 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 EN 13824:2005-02

Отменен

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements; German version EN 13824:2004 — 64 стр.