Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1 (ISO 15225:2000/A1:2004)
€28.00
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006)
€121.00
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
€69.00
Information supplied by the manufacturer of medical devices
€74.00
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
€114.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
€125.00
Clinical investigation of medical devices for human subjects - Good clinical practice
€59.00
€62.00
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
€83.00
Medical device software - Software life-cycle processes
€96.00
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
€91.00
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
€123.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
€134.00
