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ISO/IEC 17025:2005
|
General requirements for the competence of testing and calibration laboratories |
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ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
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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 ISO 8601:2006-09
|
DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
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EN 550 : 1994
|
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
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ISO/IEC 17050-1:2004
|
Conformity assessment Supplier's declaration of conformity Part 1: General requirements |
|
ISO 11607-2:2006
|
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
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ISO 11138-3:2017
|
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
|
DIN EN ISO/IEC 17050-1:2010-08
|
Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements (ISO/IEC 17050-1:2004, corrected version 2007-06-15); German and English version EN ISO/IEC 17050-1:2010 |
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DIN EN ISO 13485:2016-08
|
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
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ISO 15882:2008
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Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
|
ISO 11135:2014
|
Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
|
EN 285:2015
|
Sterilization - Steam sterilizers - Large sterilizers |
|
ISO/TS 17665-2:2009
|
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
|
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
|
ISO 11140-3:2007
|
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
|
DIN EN ISO 14161:2010-03
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
|
EN 14180:2014
|
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
|
ISO 11138-2:2017
|
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
|
ISO 18472:2006
|
Sterilization of health care products Biological and chemical indicators Test equipment |
|
ISO 11140-4:2007
|
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration |
|
EN 552:1994/A2:2000
|
STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
|
ISO 8601:2004
|
Data elements and interchange formats Information interchange Representation of dates and times |
|
ISO 20857:2010
|
Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
|
ISO/TS 11139:2006
|
Sterilization of health care products Vocabulary |
|
ISO 11137-3:2017
|
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
|
DIN EN ISO 11140-4:2007-07
|
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007) |
|
ISO 11137-2:2013
|
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
|
DIN EN ISO 11140-3:2009-09
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST |
|
ISO 9001:2015
|
Quality management systems — Requirements |
|
DIN EN ISO 18472:2006-10
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
|
DIN EN ISO 9001:2015-11
|
QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
|
ISO 11140-5:2007
|
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
|
ISO 11138-1:2017
|
Sterilization of health care products — Biological indicators — Part 1: General requirements |
|
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
|
ISO 14161:2009
|
Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
|
ISO 11138-4:2017
|
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes |
|
ISO 11138-5:2017
|
Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
|
EN 1422:2014
|
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
|
EN 13060:2014
|
Small steam sterilizers |
|
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |