DIN EN ISO 13408-6:2013-07

Superseded

View Superseded by

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)

Available format(s)

Hardcopy , PDF

Superseded date

11-07-2021

Language(s)

German, English

Published date

07-01-2013

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DevelopmentNote	Supersedes DIN EN 13824. (09/2011)
DocumentType	Standard
Pages	28
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 13408-6:2021-11
Supersedes	DIN EN ISO 13408-6:2011-09

Standards	Relationship
EN ISO 13408-6:2011/A1:2013	Identical
ISO 13408-6:2005	Identical

DIN EN ISO 13408-1:2015-12	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
DIN EN ISO 14534:2015-08	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
DIN HDBK 406 : 2ED 2016

ISO 13408-4:2005	Aseptic processing of health care products — Part 4: Clean-in-place technologies
IEST RP CC006.2 : 1997	TESTING CLEANROOMS
ISO/TS 17665-3:2013	Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
DIN EN ISO 14644-1:2016-06	CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
ISO 10648-1:1997	Containment enclosures — Part 1: Design principles
ISO/TS 17665-2:2009	Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
DIN EN ISO 14971:2013-04	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
DIN EN ISO 13408-1:2015-12	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
DIN EN ISO 17665-1:2006-11	Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
DIN EN ISO 13408-4:2011-09	Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
DIN ISO/TS 17665-2:2009-07	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
DIN EN ISO 13408-5:2011-09	Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
ISO 13408-1:2008	Aseptic processing of health care products — Part 1: General requirements
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 14644-7:2004	Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 14644-1:2015	Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 10648-2:1994	Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO/IEC 90003:2014	Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 13408-5:2006	Aseptic processing of health care products Part 5: Sterilization in place