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ISO 13408-4:2005
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Aseptic processing of health care products — Part 4: Clean-in-place technologies |
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IEST RP CC006.2 : 1997
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TESTING CLEANROOMS |
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ISO/TS 17665-3:2013
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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 |
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DIN EN ISO 14644-1:2016-06
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CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015) |
|
ISO 10648-1:1997
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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
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
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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
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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 |