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Number of results 9
UNE-EN ISO 11737-1:2018/A1:2022
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
UNE-EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
UNE-EN ISO 14160:2021
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) (Endorsed by Asociación Española de Normalización in September of 2021.)
UNE-EN IEC 60601-2-83:2020/A11:2021
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (Endorsed by Asociación Española de Normalización in May of 2021.)
UNE-EN ISO 11737-2:2020
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
UNE-EN IEC 60601-2-83:2020
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN ISO 11737-1:2018
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
UNE-EN ISO 11137-1:2015
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
UNE-EN ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)