
Biological Evaluation Of Medical Devices - Part 1: Guidance On Selection Of Tests
出版:German Institute for Standardisation (Deutsches Institut für Normung)

专家解读视频
Gives advice on the fundamental principles governing the biological evaluation of medical devices; and the selection of appropriate tests. Also helps with the definition of categories of devices based on the nature and duration of contact with the body. Also gives detailed definitions, tables and annexes.
ISO 10993-1:2003 - Similar
UNI EN 30993-1:1995 - Identical
I.S. EN 30993-1:1995 - Identical
BS EN 30993-1:1994 - Identical
ONORM EN 30993-1:1994 - Identical
SS EN 30993-1:1994 - Identical
UNE EN 30993-1:1994 - Identical
NF EN 30993-1:1994 - Identical