Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices— 26 стр.
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices— 20 стр.
Medical devices utilizing animal tissues and their derivatives. Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents— 34 стр.