Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes -- Amendment 1— 8 стр.
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems -- Amendment 1— 16 стр.
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices— 12 стр.
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems— 157 стр.
Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests— 33 стр.
Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices -- Amendment 1— 10 стр.
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices— 48 стр.
Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves -- Amendment 1: Filtration and information to be supplied by the manufacturer— 6 стр.
Medical gas pipeline systems -- Part 1: Pipeline systems for compressed medical gases and vacuum -- Amendment 3: Terminology relating to alarm systems— 6 стр.
Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators -- Technical Corrigendum 1— 4 стр.
Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment— 52 стр.
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation— 28 стр.
