UNI EN ISO 10993-1:2010現行
Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
出版：Italian Standards
專家解讀視頻
Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device.
Supersedes UNI EN 30993-1 (07/1999)
NBN EN ISO 10993-1:2009 - Identical
I.S. EN ISO 10993-1:2009 - Identical
NS EN ISO 10993-1:2009 - Identical
SS EN ISO 10993-1 Ed. 4 (2009) - Identical
ONORM EN ISO 10993-1:2010 - Identical
DIN EN ISO 10993-1 (2010-04) - Identical
BS EN ISO 10993-1:2009 (October) - Identical
UNE EN ISO 10993-1:2010 - Identical
SN EN ISO 10993-1:2010 - Identical
NF EN ISO 10993-1:2010 - Identical
ONORM EN ISO 10993-1:2011 - Identical
BS EN ISO 10993-1:2009 - Identical
NEN EN ISO 10993-1:2009 - Identical
NF EN ISO 10993-1:2009 - Identical
EN ISO 10993-1:2009 - Identical
