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.
Quality systems - Model for quality assurance in design/development, production, installation and servicing (ISO 9001:1994); trilingual version EN ISO 9001:1994— 28 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version EN ISO 11137-2:2007— 76 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007— 75 стр.
