Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (Identical to ISO 13485:1996); German version EN ISO 13485:2000.
€77.20
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003; German version EN 46003:1999
€69.91
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
Quality systems - Medical devices - System requirements for regulatory purposes (ISO/DIS 13485:2002)
€134.02
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO/DIS 10993-14:1999); German version prEN ISO 10993-14:1999
Biological evaluation of medical devices - Part 17: Methods for the establishment of allowable limits for leachable substances using health-based risk assessment (ISO/DIS 10993-17:1999); German version prEN ISO 10993-17:1999
€105.42
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
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 version EN ISO 15378:2017/A1:2024
€0.00
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements of air ambulances; German version EN 13718-2:2008
€111.40
Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007, Corrigenda to DIN EN ISO 14971:2007-07.
Symbols for use in the labelling of medical devices; German version EN 980:2008.
€122.34
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO/DIS 15225:2008); German version prEN ISO 15225:2008
Laboratory centrifuges; data card
€41.78
