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DIN HDBK 406 : 2ED 2016

Current
Current

The latest, up-to-date edition.

Published date

18-08-2014

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

The individual standards included in this DIN Handbook are listed in the Reference Standards fields.

DocumentType
Standard
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

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)
DIN EN 556-2:2015-11 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
DIN EN 556-1:2002-03 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES
DIN EN ISO 13408-6:2013-07 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
DIN EN ISO 13408-7:2015-11 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)
DIN EN ISO 14644-2:2016-05 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: MONITORING TO PROVIDE EVIDENCE OF CLEANROOM PERFORMANCE RELATED TO AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-2:2015)
DIN EN ISO 13408-3:2011-09 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
DIN EN ISO 14644-4:2003-06 Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001)
DIN EN ISO 13408-2:2011-09 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
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 14644-5:2005-03 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
DIN EN ISO 13408-4:2011-09 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
DIN EN ISO 13408-5:2011-09 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
DIN EN ISO 22442-3:2008-03 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS

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