GOST R ISO 20857-2016 Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices
IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61010-2-040:2015 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
ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
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 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
GOST R ISO 20857-2016 history
2016GOST R ISO 20857-2016 Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices