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Number of results 988
UNE-EN ISO 11139:2020/A1:2024
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 11139:2018/Amd 1:2024)
UNE-EN IEC 60601-2-75:2019/A1:2024
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (Endorsed by Asociación Española de Normalización in November of 2024.)
UNE-EN IEC 80601-2-78:2020/A1:2024
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (Endorsed by Asociación Española de Normalización in November of 2024.)
UNE-EN ISO 15378:2018/A1:2024
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)
UNE-EN 60601-1:2008/A13:2024
Medical electrical equipment - Part 1: General requirements for safety
UNE-EN IEC 80601-2-26:2020/A1:2024
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in May of 2024.)
UNE-EN IEC 60601-2-35:2021/A1:2024
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use (Endorsed by Asociación Española de Normalización in March of 2024.)
UNE-EN IEC 80601-2-77:2021/A1:2023
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Endorsed by Asociación Española de Normalización in February of 2024.)
UNE-EN ISO 13132:2023
Laboratory glassware - Petri dishes (ISO 13132:2023) (Endorsed by Asociación Española de Normalización in June of 2023.)
UNE-EN IEC 80601-2-59:2019/A1:2023
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Endorsed by Asociación Española de Normalización in April of 2023.)
UNE-EN ISO 9999:2023
Assistive products - Classification and terminology (ISO 9999:2022)
UNE-EN 60601-1:2008/A2:2021
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Endorsed by Asociación Española de Normalización in December of 2022.)
UNE-EN ISO 13485:2018/A11:2022
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
UNE-EN ISO 10993-7:2009/A1:2022
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
UNE-EN ISO 14971:2020/A11:2022
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 22748:2022
Absorbent incontinence products for urine and/or faeces - Product type names and illustrations (ISO 22748:2021)
UNE-EN ISO 15223-1:2022
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
UNE-EN IEC 81001-5-1:2022
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (Endorsed by Asociación Española de Normalización in March of 2022.)
UNE-EN ISO 20417:2021
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
UNE-EN IEC 80601-2-26:2020/AC:2021-10
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in December of 2021.)
UNE-EN IEC 80001-1:2021
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (Endorsed by Asociación Española de Normalización in December of 2021.)
UNE-EN ISO 1942:2021
Dentistry - Vocabulary (ISO 1942:2020)
UNE-EN ISO 14155:2021
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
UNE-EN 17210:2021
Accessibility and usability of the built environment - Functional requirements