In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011— 60 стр.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2009— 62 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012); German version EN ISO 11608-3:2012— 18 стр.
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012); German version EN ISO 11608-5:2012— 24 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012); German version EN ISO 11980:2012— 33 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 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006); German version EN ISO 11137-1:2006— 49 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009); German version EN ISO 11980:2009— 36 стр.
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices