DIN EN ISO 11135-1:2007-08
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
17/30363625 DC : DRAFT SEP 2017
|
BS EN ISO 11138-7 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 7: GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
PLUS 1173 (1st ed. pub. 2012)
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Guide to the selection and use of sterilization indicators |
08/30149503 DC : DRAFT JAN 2008
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BS EN ISO 14161 - STERILIZATION OF HEALTH CAR PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
11/30252448 DC : 0
|
BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
CSA Z15882 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
DD CEN ISO/TS 11135-2:2008
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Sterilization of health care products. Ethylene oxide Guidance on the application of ISO 11135-1 |
16/30302485 DC : 0
|
BS EN ISO 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT |
DIN EN ISO 11135:2014-10
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
07/30157769 DC : DRAFT DEC 2007
|
BS EN ISO 11737-2 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS |
CSA Z1416: 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
CSA Z11135-2 : 2009 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
ANSI/AAMI/ISO 11135:2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN ISO 11140-1:2015-03
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
DIN EN 1422:2014-08
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
BS EN ISO 11140-1:2014
|
Sterilization of health care products. Chemical indicators General requirements |
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
UNE-EN ISO 14161:2010
|
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
BS EN ISO 14534:2015
|
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
BS EN ISO 14161:2009
|
Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results |
DIN EN 1422:1997-11
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
CEN ISO/TS 11135-2:2008/AC:2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
DIN EN ISO 15882:2008-12
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STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
EN ISO 11140-1:2014
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
PREN 1422 : DRAFT 2011
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
UNE-EN ISO 16061:2015
|
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
04/30090382 DC : DRAFT NOV 2004
|
ISO 13408-5 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: CLEANING IN PLACE |
04/30078095 DC : DRAFT JUL 2004
|
ISO 11138-1 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
BS EN 60601-2-12:2006
|
Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
DIN EN ISO 18472:2006-10
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
11/30244091 DC : 0
|
BS EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z14161 : 2011 : R2015
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
NF CEN ISO/TS 11135-2 : 2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
DIN EN ISO 16061:2015-09
|
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
ISO 11737-1:2018
|
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
BS EN ISO 18472:2006
|
Sterilization of health care products. Biological and chemical indicators. Test equipment and methods |
EN ISO 18472:2006
|
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006) |
AAMI ISO 11737-2 : 2009 : R2014
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
AAMI ISO 11737-2 :2009
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
UNI EN 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 |
BS EN ISO 11737-2:2009
|
Sterilization of medical devices. Microbiological methods Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
I.S. EN ISO 14534:2015
|
OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
I.S. EN ISO 11140-1:2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014) |
I.S. EN 1422:2014
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
UNI EN ISO 11737-2 : 2010
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
I.S. EN ISO 15882:2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
VDI 6300 Blatt 1:2016-05
|
Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
04/30048118 DC : DRAFT MAY 2004
|
BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
13/30285624 DC : 0
|
BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
16/30330536 DC : 0
|
BS EN ISO 18472 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
09/30207531 DC : 0
|
BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
AAMI ISO 15882 : 2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
BS EN 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 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 (ISO 11135:2014) |
03/103294 DC : DRAFT JAN 2003
|
BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES |
CSA Z11135-1 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z15882:09 (R2019)
|
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01) |
CEI EN 60601-2-12 : 2007
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
I.S. EN ISO 11737-1:2018&LC:2018
|
STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018) |
UNI CEN ISO/TS 11135-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
AAMI ISO 11135-1 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ISO 11737-2:2009
|
Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
ISO 17218:2014
|
Sterile acupuncture needles for single use |
UNE-EN ISO 11140-1:2015
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
I.S. EN ISO 14161:2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
I.S. EN ISO 11737-2:2009
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
EN ISO 14161:2009
|
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
UNI EN ISO 15882 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
UNI EN ISO 14161 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
UNI EN 1422 : 2014
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
15/30282343 DC : 0
|
BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES |
AAMI ISO 11737-1 : 2006
|
STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT |
I.S. EN ISO 11135-1:2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
13/30259011 DC : 0
|
BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE |
ISO 18746:2016
|
Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use |
CSA Z15882 :2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
04/30081258 DC : DRAFT MARCH 2004
|
BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS |
03/103293 DC : DRAFT JAN 2003
|
BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
CSA Z11135-1 :2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
BS EN ISO 16061:2015
|
Instrumentation for use in association with non-active surgical implants. General requirements |
CSA Z11135-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
CSA Z11135-1 : 2009 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN ISO 11737-1:2009-09
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
AAMI ISO 14161 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
I.S. EN 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 (ISO 11135:2014) |
UNI EN ISO 11737-1 : 2006
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
S.R. CEN ISO TS 11135-2:2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
ONORM EN ISO 18472 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
ISO 18472:2006
|
Sterilization of health care products Biological and chemical indicators Test equipment |
I.S. EN ISO 18472:2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
I.S. EN 60601-2-12:2006
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
I.S. EN ISO 16061:2015
|
INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
DIN EN ISO 14161:2010-03
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
DIN EN ISO 14534:2015-08
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
ISO 16061:2015
|
Instrumentation for use in association with non-active surgical implants General requirements |
ANSI/AAMI/ISO 15882:2008(R2013)
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
EN ISO 11737-2:2009
|
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
ISO 14534:2011
|
Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
ISO/TS 11135-2:2008
|
Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
UNE-EN ISO 14534:2015
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
BS EN ISO 15882:2008
|
Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results |
EN ISO 11135-1:2007
|
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
EN 1422:2014
|
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
EN ISO 14534:2015
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
EN ISO 15882:2008
|
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008) |
BS ISO 17218:2014
|
Sterile acupuncture needles for single use |
PREN ISO 11135 : DRAFT 2011
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011) |
AAMI TIR20 : 2001
|
PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION |
CSA Z11135 : 2015
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z11135-2 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
AAMI ISO 11737-1 : 2006 : R2011
|
STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT |
AAMI ISO 18472 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
UNE-EN ISO 11135:2015
|
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
AAMI ISO TIR 11135-2 : 2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 11135-1 |
CSA ISO 11140-1 : 2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
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 |
DIN EN ISO 11737-2:2010-04
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
UNE-EN ISO 11737-2:2010
|
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
BS EN 1422:2014
|
Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods |
BS EN ISO 11135-1:2007
|
Sterilization of health care products. Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 15882:2008
|
Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
ISO 14161:2009
|
Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
EN ISO 16061:2015
|
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
EN 60601-2-12:2006
|
Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |