Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO<sub>2</sub> Tracer Gas Method— 5 стр.
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO<sub>2 </sub> Tracer Gas Method— 4 стр.
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of <i>Staphylococcus aureus</i>— 5 стр.
Packaging materials and systems for medical devices which are to be sterilized. Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). Requirements and test methods— 12 стр.
Packaging materials and systems for medical devices which are to be sterilized. Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods— 12 стр.
Packaging materials and systems for medical devices which are to be sterilized. Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods— 10 стр.
Packaging materials and systems for medical devices which are to be sterilized. Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods— 12 стр.
Packaging materials and systems for medical devices which are to be sterilized. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods— 12 стр.
Packaging materials and systems for medical devices which are to be sterilized. Uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids. Requirements and test methods— 12 стр.
Packaging materials and systems for medical devices which are to be sterilized. Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids. Requirements and test methods— 16 стр.
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products— 18 стр.
Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices— 50 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery— 32 стр.
Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods— 26 стр.
Packaging for terminally sterilized medical devices. Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods— 20 стр.
Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer— 64 стр.
Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods— 22 стр.
Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods— 22 стр.
Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery— 30 стр.
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels— 24 стр.
Implants for surgery - Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (english version)
