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.
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Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer— 64 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)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)