Information supplied by the manufacturer of medical devices; German version EN 1041:2008/FprA1:2013
€41.78
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012); German version EN ISO 15223-1:2012, with CD-ROM.
€134.02
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009
€167.66
Graphical symbols for use in the labelling of medical devices; German version prEN 980:2002
€91.03
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO/DIS 14155-1:2001); German Version prEN ISO 14155-1:2001
€98.32
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO/DIS 14155-2:2001); German version prEN ISO 14155-2:2001
€69.91
Graphical symbols for use in the labelling of medical devices (including amendment A1:1999 and amendment A2:2001); German version EN 980:1996 + A1:1999 + A2:2001
€77.20
Medical devices - Application of risk management to medical devices; Amendment 1: Rationale for requirements (ISO 14971:2000/FDAM 1:2002); German version EN ISO 14971:2001/prA1:2002
€63.27
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange; Amendment A1 (ISO 15225:2000/DAM 1:2002); German version EN ISO 15225:2000/prA1:2002
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004); German version EN ISO 15225:2000/prA2:2005
€48.79
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001; German version EN 46001:1996.
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002; German version EN 46002:1996.
Medical devices - Risk analysis; German version EN 1441:1997
Compatibilité électromagnétique et spectre radioélectrique (ERM) - Dispositifs à courte portée (SRD) - Implants médicaux actifs de faible puissance (LP-AMI) fonctionnant dans la plage de fréquences de 2 483,5 MHz à 2 500 MHz - Partie 1 : caractéristiques techniques et méthodes d'essai (V1.1.2)
€113.50
Compatibilité électromagnétique et spectre radioélectrique (ERM) - Dispositifs à courte portée (SRD) - Implants médicaux actifs de faible puissance (LP-AMI) fonctionnant dans la plage de fréquences de 2 483,5 MHz à 2 500 MHz - Partie 2 : norme europénne (EN) harmonisée couvrant les exigences essentielles de l'article 3, paragraphe 2 de la Directive R&TTE (V1.1.2)
€72.00
