|
ISO/IEC 17025:2005
|
General requirements for the competence of testing and calibration laboratories |
|
ISO 19011:2011
|
Guidelines for auditing management systems |
|
ISO 11138-3:2017
|
Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
|
EN 285:2015
|
Sterilization - Steam sterilizers - Large sterilizers |
|
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 11737-1:2006
|
Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
|
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
|
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 |
|
AAMI TIR31 : 2008
|
PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES |
|
ISO 11138-2:2017
|
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
|
ISO/IEC 17011:2004
|
Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies |
|
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 18472:2006
|
Sterilization of health care products Biological and chemical indicators Test equipment |
|
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 9001:2015
|
Quality management systems — Requirements |
|
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary |
|
ISO/IEC Guide 2:2004
|
Standardization and related activities General vocabulary |
|
ISO 11138-1:2017
|
Sterilization of health care products — Biological indicators — Part 1: General requirements |
|
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 |
|
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 |