BS PD ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices*， 2023-12-24 Update
EN 556-1 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2023-12-24 Update
ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4*， 2018-11-08 Update
ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
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 13408 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
ISO 14001 Environmental management systems*， 2024-01-01 Update
ISO 14040 Environmental management — Life cycle assessment — Principles and framework — Amendment 1*， 2023-12-24 Update
ISO 14160 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen*， 2020-09-21 Update
ISO 14161 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
ISO 14937 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
ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 20857 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 22442-1 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management*， 2020-09-15 Update
ISO 22442-2 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling*， 2020-09-15 Update
ISO 22442-3 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 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
ISO 9001 Quality management systems*， 2024-01-01 Update
ISO 9004 Quality management and quality system elements — Part 3: Guidelines for processed materials*， 2018-04-03 Update
ISO/IEC GUIDE 51 Safety aspects - Guidelines for their inclusion in standards
ISO/TS 13004:2013 Sterilization of health care products.Radiation.Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD>
BS PD ISO/TS 19930:2017 history
2017BS PD ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6