Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007); German version EN ISO 81060-1:2012— 50 стр.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007); German version EN ISO 10993-12:2009— 28 стр.
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004); German version EN ISO 10651-6:2009— 43 стр.
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010— 26 стр.
Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007); German version EN ISO 8835-3:2009— 33 стр.
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004); German version EN ISO 10651-2:2009— 47 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009— 75 стр.
Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012); German version EN ISO 13504:2012— 24 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.
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2009— 32 стр.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009— 17 стр.
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); German and English version EN ISO 15378:2007— 155 стр.
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (IEC 60601-1-6:2010) (english version)
