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 |
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) |
16/30346073 DC : 0
|
BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
BS EN 16602-70-56:2015
|
Space product assurance. Vapour Phase Bioburden Reduction for Flight Hardware |
CSA Z1416: 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
CSA ISO 14937 : 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
S.R. CEN ISO/TS 16775:2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
CAN/CSA-ISO/TS 16775:17
|
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
ISO 16142-2:2017
|
Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
DIN EN ISO 11140-1:2015-03
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
BS EN ISO 11140-1:2014
|
Sterilization of health care products. Chemical indicators General requirements |
UNE-EN ISO 14161:2010
|
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
UNE-EN ISO 16672:2016
|
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
BS EN ISO 14161:2009
|
Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results |
ISO 11140-1:2014
|
Sterilization of health care products Chemical indicators Part 1: General requirements |
DIN EN ISO 15882:2008-12
|
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) |
CEN ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
ISO/TR 20520:2018
|
Traditional Chinese medicine Infection control for acupuncture treatment |
15/30328959 DC : 0
|
BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
PD CEN ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
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) |
CSA Z14161 : 2011 : R2015
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
I.S. EN 16602-70-57:2015
|
SPACE PRODUCT ASSURANCE - DRY HEAT BIOBURDEN REDUCTION FOR FLIGHT HARDWARE |
14/30266295 DC : 0
|
BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS |
ANSI/AAMI/ISO 16142-2:2017
|
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
ISO/TS 19930:2017
|
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
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 |
EN ISO 14937:2009
|
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
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 ISO 16672:2015-12
|
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
BS EN 556-2:2015
|
Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices |
I.S. EN ISO 14937:2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
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 ISO 11138-4:2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017) |
I.S. EN ISO 15882:2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
I.S. EN ISO 16672:2015
|
OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
ANSI/AAMI/ISO 11138-4:2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES |
PREN 556-2 : DRAFT 2014
|
STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
15/30321511 DC : 0
|
BS EN ISO 11138-4 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES |
ANSI/AAMI/ISO 14937:2009(R2013)
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
BS ISO 16142-1:2016
|
Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
14/30290166 DC : 0
|
BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
AAMI ISO 15882 : 2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
CSA ISO 14937 : 2011 : R2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ISO 18362:2016
|
Manufacture of cell-based health care products Control of microbial risks during processing |
AAMI ISO 14937:2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ANSI/AAMI/ISO 17664:2017
|
PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
I.S. EN ISO 17664:2017
|
PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
ISO 17664:2017
|
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
UNE-EN ISO 11140-1:2015
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
UNE-EN ISO 11138-4:2017
|
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017) |
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 14937 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
BS EN 16602-70-57:2015
|
Space product assurance. Dry Heat Bioburden Reduction for Flight Hardware |
BS ISO 16142-2:2017
|
Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
I.S. EN 556-2:2015
|
STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
ISO 16142-1:2016
|
Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
14/30295064 DC : 0
|
BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES |
16/30280931 DC : DRAFT APR 2016
|
BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
BS EN ISO 17664:2017
|
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices |
AAMI ISO 14161 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
ISO 11737-1:2018
|
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
ANSI/AAMI/ISO TIR16775:2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
PD ISO/TS 19930:2017
|
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
ISO 13485 - PRACTICAL GUIDE : 2016
|
ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE |
DIN EN ISO 14161:2010-03
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
ISO 14937:2009
|
Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
UNE-EN 556-2:2016
|
Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ANSI/AAMI/ISO 15882:2008(R2013)
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR 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 16672:2015
|
Ophthalmic implants Ocular endotamponades |
BS EN ISO 11138-4:2017
|
Sterilization of health care products. Biological indicators Biological indicators for dry heat sterilization processes |
UNE-EN ISO 14937:2010
|
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
EN ISO 11138-4:2017
|
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017) |
UNI CEN ISO/TS 16775 : 2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
EN 556-2:2015
|
Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
EN 16602-70-57:2015
|
Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware |
EN 16602-70-56:2015
|
Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware |
BS ISO 18362:2016
|
Manufacture of cell-based health care products. Control of microbial risks during processing |
I.S. EN 16602-70-56:2015
|
SPACE PRODUCT ASSURANCE - VAPOUR PHASE BIOBURDEN REDUCTION FOR FLIGHT HARDWARE |
14/30273161 DC : 0
|
BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED ''STERILE'' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
CAN/CSA-ISO 11138-4:17
|
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization (Adopted ISO 11138-4:2017, second edition, 2017-03) |
CSA ISO 11140-1 : 2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
EN ISO 17664:2017
|
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017) |
DIN EN ISO 11138-4:2015-10 (Draft)
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017) |
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) |
ISO 14161:2009
|
Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
BS EN ISO 16672:2015
|
Ophthalmic implants. Ocular endotamponades |