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— 14 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08); German version EN ISO 14607:2018— 58 стр.