Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007); German version EN ISO 7197:2009— 14 стр.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); German version EN ISO 11135-1:2007— 52 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137-2:2009); German version prEN ISO 11137-2:2009
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); English version FprEN ISO 14155-1:2009, Amendment 1
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version FprEN ISO 14155-2:2009, Amendment 1
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— 2 стр.
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006); German version EN ISO 7197:2006, Corrigendum to DIN EN ISO 7197:2006-09; German version EN ISO 7197:2006/AC:2008— 2 стр.
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007); English version prEN ISO 7197:2008, Amendment A1
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006); German version EN ISO 7197:2006, Corrigendum to DIN EN ISO 7197:2006-09; German version EN ISO 7197:2006/AC:2008— 2 стр.
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2003); German version EN ISO 8362-4:2004, text in German and English— 13 стр.
