ISO 1 Geometrical product specifications (GPS) — Standard reference temperature for the specification of geometrical and dimensional properties*， 2022-06-14 Update
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne*， 2023-12-21 Update
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 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*， 2017-06-01 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 14155 Clinical investigation of medical devices for human subjects — Good clinical practice*， 2020-07-28 Update
ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices*， 2017-09-30 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 7151 Surgical instruments; non-cutting, articulated instruments; general requirements and test methods
ISO 7153 Surgical instruments - Materials - Part 1: Metals*， 2016-10-01 Update
ISO 7153-1:1991 Surgical instruments; metallic materials; part 1: stainless steel
ISO 7740 Instruments for surgery; Scalpels with detachable blades; Fitting dimensions
ISO 80000-1 Quantities and units - Part 1: General*， 2022-12-06 Update
ISO 8319-2 Orthopaedic instruments; Drive connections; Part 2 : Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
BS EN ISO 16061:2015 history
2021BS EN ISO 16061:2021 Instruments for use in association with non-active surgical implants. General requirements
2015BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
2009BS EN ISO 16061:2009 Instrumentation for use in association with non-active surgical implants - General requirements