Medical electrical equipment. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use— 72 стр.
Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices— 54 стр.
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)— 82 стр.
Medical electrical equipment. Deployment, implementation and operational guidelines for indentifying febrile humans using a screening thermograph— 30 стр.
Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer— 64 стр.
Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment— 14 стр.
Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment— 26 стр.
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests— 128 стр.
Sharps injury protection. Requirements and test methods. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling— 22 стр.
Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices— 52 стр.
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 1: Devices that require cleaning followed by disinfection and/or sterilization— 32 стр.
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use— 22 стр.
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)— 94 стр.
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)— 76 стр.
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation— 26 стр.
