BS EN ISO 11737-1:2018
Sterilization of health care products. Microbiological methods. Determination of a population of microorganisms on products
- Standard No.
- BS EN ISO 11737-1:2018
- Release Date
- 2018
- Published By
- British Standards Institution (BSI)
- Status
- Replace By
- BS EN ISO 11737-1:2018+A1:2021
- Latest
- BS EN ISO 11737-1:2018+A1:2021
- Replace
- BS EN ISO 11737-1:2006
BS EN ISO 11737-1:2018 Referenced Document
- AAMI TIR37 Sterilization of health care products - Radiation - Guidance on sterilization of biologics and tissue-based products
- ASTM D4855-97 Standard Practice for Comparing Test Methods
- ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
- 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*， 2023-12-23 Update
- ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11139 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions
- 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 13022 Medical products containing viable human cells - Application of risk management and requirements for processing practices
- ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
- 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 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 15189 Medical laboratories — Particular requirements for quality and competence*， 2023-12-23 Update
- 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 22442-3 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 7870-2 Control charts — Part 2: Shewhart control charts*， 2023-03-14 Update
- ISO 7870-4 Control charts — Part 4: Cumulative sum charts*， 2021-09-21 Update
- ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
- ISO 9001 Quality management systems*， 2024-01-01 Update
- ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
- ISO/IEC 90003 Software engineering - Guidelines for the application of ISO 9001:2008 to computer software
BS EN ISO 11737-1:2018 history
- 1970 BS EN ISO 11737-1:2018+A1:2021 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- 2018 BS EN ISO 11737-1:2018 Sterilization of health care products. Microbiological methods. Determination of a population of microorganisms on products
- 2006 BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
- 1997 BS EN 1174-2:1997 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Guidance
- 1996 BS EN 1174-1:1996 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Requirements
