Amending Implementing Decision (EU) 2021/1182 regards harmonized standards for the biological evaluation of medical devices, sterilization of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment. See table.
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Standard |
Title |
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EN ISO 13485:2016/ A11:2021 |
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021 |
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EN ISO 10993-23:2021 |
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) |
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EN ISO 10993-9:2021 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) |
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EN ISO 10993-12:2021 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
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EN ISO 13408-6:2021 |
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) |
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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) |
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EN ISO 15223-1:2021 |
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) |
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EN ISO 17664-1:2021 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) |
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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) EN ISO 11737-1:2018/A1:2021 |
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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 EN IEC 60601-2-83:2020/A11:2021. |
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EN ISO 17511:2021 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |