Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests— 33 стр.
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems -- Amendment 1— 16 стр.
Basic environmental testing procedures. Part 2: Tests. Mounting of components, equipment and other articles for dynamic tests including shock (Ea), bump (Eb), vibration (Fc and Fd) and steady-state acceleration (Ga) and guidance— 13 стр.
Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices— 106 стр.
Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer— 64 стр.
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices— 48 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.
