Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
€50.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)
Medical supply units (ISO 11197:2004)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024); German version EN ISO 16571:2024
€140.00
Requirements for planning and safety in the multifunctional high-tech working environment surgical theatre/interventional suite
€122.34
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
Systems for evacuation of plume generated by medical devices (ISO/DIS 16571:2023); German and English version prEN ISO 16571:2023
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021); German version EN ISO 15223-1:2021, with CD-ROM.
€179.53
Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
Cleanliness of medical devices - Risk orientated validation of cleanliness, development of acceptance criteria and selection of test methods; Text in German and English
€89.16
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12); German version EN ISO 20417:2021
€195.79
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); German and English version EN ISO 15378:2017/prA1:2024
€0.00
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1 (ISO 15223-1:2021/DAM 1:2024); German and English version EN ISO 15223-1:2021/prA1:2024
€41.78
Medical Devices - Information to be provided by the manufacturer (ISO/DIS 20417:2019); German and English version prEN ISO 20417:2019
Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019
€134.02
