YY/T 1276-2016 Requirements for the development, validation and routine control of dry heat sterilization process for medical devices (English Version)
This standard specifies the requirements for the development, validation and routine control of medical devices during dry heat sterilization. This standard mainly relates to dry heat sterilization. It also specifies the requirements and provides relevant guidance on the depyrogenation process using dry heat for sterilization. This standard does not specify requirements for the development, validation, and routine control of sterilization processes used to inactivate spongiform encephalopathy pathogens such as scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease. This standard does not apply to infrared or microwave sterilization. This standard does not specify medical devices labeled "sterile" in detail. See the requirements of EN 556-1. This standard does not detail the quality management system that controls all production stages of medical device products. This standard does not specify occupational safety requirements related to the design and operation of dry heat sterilization and depyrogenation equipment.
YY/T 1276-2016 Referenced Document
IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements*， 2017-01-01 Update
ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
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 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process*， 2019-12-02 Update
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
YY/T 1276-2016 history
2016YY/T 1276-2016 Requirements for the development, validation and routine control of dry heat sterilization process for medical devices