ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories |
ISO 19011:2011
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Guidelines for auditing management systems |
ISO 11138-3:2017
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Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
EN 285:2015
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Sterilization - Steam sterilizers - Large sterilizers |
ISO 11737-2:2009
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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 |
CSA Z314.7 : 2003(R2018)
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STEAM STERILIZERS FOR HEALTH CARE FACILITIES |
ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
CAN/CSA-ISO 13485:16
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Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01) |
CSA Z314.2 : 2009
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EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
ISO 14937:2009
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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 |
AAMI TIR31 : 2008
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PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES |
ISO 11138-2:2017
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Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
ISO/IEC 17011:2004
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Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies |
ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment |
ISO 20857:2010
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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 9001:2015
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Quality management systems — Requirements |
CSA ISO 9001 : 2016
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QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
ISO/IEC Guide 2:2004
|
Standardization and related activities General vocabulary |
ISO 11138-1:2017
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Sterilization of health care products — Biological indicators — Part 1: General requirements |
ISO 11138-4:2017
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Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes |
ISO 11138-5:2017
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Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
ISO 17665-1:2006
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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 |