90/385/EEC COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
98/79/EC Directive of the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
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 Medical devices - Quality management systems - Requirements for regulatory purposes*， 2016-03-01 Update
ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
BS EN ISO 11137-2:2015 history
2023BS EN ISO 11137-2:2015+A1:2023 Sterilization of health care products. Radiation - Establishing the sterilization dose
2015BS EN ISO 11137-2:2015 Sterilization of health care products. Radiation. Establishing the sterilization dose
2006BS EN ISO 11137-1:2006+A1:2013 Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
0000 BS EN ISO 11137-1:2006
1994BS EN 552:1994 Sterilization of medical devices - Validation and routine control of sterilization by irradiation