DIN EN 1441 (1998-01)被替代
Medical Devices - Risk Analysis
出版：German Institute for Standardisation (Deutsches Institut für Normung)
专家解读视频
Defines a method for investigation by the manufacturer of the safety of a medical device, including in vitro diagnostic devices or accessories, by identification of hazards and estimation of the risks associated with the device. Particularly helpful in areas where relevant standards are unavailable or unused. Does not define levels of acceptability, or give detailed guidance on management of risks. Nor does it cover decision-making processes regarding assessing the indications and contra-indications for using a particular device.
SN EN 1441:1998 - Identical
NEN EN 1441:1997 - Identical
BS EN 1441:1998 - Identical
ONORM EN 1441:1998 - Identical
UNI EN 1441:1998 - Identical
I.S. EN 1441:1998 - Identical
NS EN 1441:1998 - Identical
SS EN 1441 Ed. 1 (1998) - Identical
UNE EN 1441:1998 - Identical
