Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
€50.00
Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024); German and English version prEN ISO 20417:2024
€179.53
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
€101.00
Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care; German version prEN 13718-1:1999
€84.58
Air, water and difficult terrain ambulances - Part 2: Operational and technical requirements for the continuity of patient care; German version prEN 13718-2:1999
€105.42
Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
€259.00
Medical devices — Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
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Medical devices — Recognized essential principles of safety and performance of medical devices Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
€51.00
Medical devices — Guidance on the application of ISO 14971
Medical devices — Quality management systems — Requirements for regulatory purposes
€225.00
Medical devices — Application of risk management to medical devices
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied Part 2: Symbol development, selection and validation
€115.00
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
€208.00
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
€184.00
