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IEC 61010-2-040 : 2.0
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SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS |
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AS/NZS 4187:2014
|
Reprocessing of reusable medical devices in health service organisations |
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AAMI ST41 : 2008
|
ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
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ISO 11607-2 : 2006(R 2015)
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
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EN 556-1 : 2001 COR 2006
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STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES |
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ISO 11737-2 : 2009(R2015)
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STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
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ISO 11737-1 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
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ISO 13485 : 2016(R2020)
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
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ISO/TS 16775 : 2014(R2018)
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
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ISO 14937 : 2009(R2015)
|
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 |
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ISO 22442-1 : 2015
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
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AAMI TIR28 : 2016
|
PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION |
|
ISO 11138-2 : 2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES |
|
AAMI TIR15 : 2016
|
PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
|
ISO/IEC GUIDE 99 : 2007(R2015)
|
INTERNATIONAL VOCABULARY OF METROLOGY - BASIC AND GENERAL CONCEPTS AND ASSOCIATED TERMS (VIM) |
|
ISO 11140-1 : 2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
|
ISO TS 11139 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
|
ISO 10993-7 : 2008(R2016)
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
|
ISO 14001:2015
|
ENVIRONMENTAL MANAGEMENT SYSTEMS - REQUIREMENTS WITH GUIDANCE FOR USE |
|
ISO 10012 : 2003(R2015)
|
MEASUREMENT MANAGEMENT SYSTEMS - REQUIREMENTS FOR MEASUREMENT PROCESSES AND MEASURING EQUIPMENT |
|
ISO 9001:2015
|
QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS |
|
ISO 22442-2 : 2015
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
|
ISO 9000 : 2015
|
QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY |
|
ISO 11138-1 : 2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
|
ISO 22442-3 : 2007(R2015)
|
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 |
|
ISO 14971 : 2007(R2010)
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
|
ISO 11607-1 : 2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
|
ISO/IEC 90003 : 2014
|
SOFTWARE ENGINEERING - GUIDELINES FOR THE APPLICATION OF ISO 9001:2008 TO COMPUTER SOFTWARE |
|
ISO 14161 : 2009(R2017)
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
|
IEC 61010-1 : 3.1:2017
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
|
ISO 14040 : 2006(R2016)
|
ENVIRONMENTAL MANAGEMENT - LIFE CYCLE ASSESSMENT - PRINCIPLES AND FRAMEWORK |
|
ISO 17664 : 2017
|
PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |