Graphical symbols for use in the labelling of medical devices (including Amendment A1:1999); German version EN 980:1996 + A1:1999
€56.17
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000); German version EN ISO 15225:2000
€91.03
Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2005); German version prEN ISO 14971:2005
€173.74
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2005)
€84.58
Medical devices — Guidance on the application of ISO 14971 Part 2: Machine learning in artificial intelligence
This product is not for sale, please contact us for more information
Clinical investigation of medical devices for human subjects - Good clinical practice
€59.00
Clinical evaluation of medical devices (ISO/DIS 18969:2025); German and English version prEN ISO 18969:2025
€134.02
Clinical evaluation of medical devices
€77.00
Appareils électromédicaux. Prescriptions de sécurité pour les systèmes électromédicaux.
€86.50
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific (ISO 15223 1:2021/Amd 1:2025)
€20.00
Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity
€141.33
Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products
€65.33
Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
€82.00
Biological evaluation of medical devices - Part 1 : evaluation and testing
Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables
