BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices
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
ANSI/AAMI ST67-2003 Sterilization of medical devices - Requirements for products labeled "STERILE"
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2023-12-23 Update
ISO 10012-1 Quality assurance requirements for measuring equipment; part 1: metrological confirmation system for measuring equipment
ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
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 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
ISO 14001:2004 Environmental management systems - Requirements with guidance for use
ISO 14040:1997 Environmental management - Life cycle assessment - Principles and framework
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 9000:2005 Quality management systems - Fundamentals and vocabulary
ISO 9001:2000 Quality management systems - Requirements
ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
BS EN ISO 11137-1:2015 history
1970BS EN ISO 11137-1:2015+A2:2019 Sterilization of health care products. Radiation. Establishing the sterilization dose
2015BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices
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