UNE EN 46002:1996被替代
Quality Systems - Medical Devices - Particular Requirements For The Application Of En Iso 9002
出版：Asociacion Espanola de Normalizacion
專家解讀視頻
Specifies the quality requirements for the production and, where relevant, installation of medical devices. Coverage includes: quality system requirements; product identification and traceability; inspection, measuring and test equipment; control of nonconforming product; handling, storage, packaging and delivery; internal quality audits. Also gives detailed definitions.
SN EN 46002:1997 - Identical
DIN EN 46002 (1996-09) - Identical
ONORM EN 46002:1996 - Identical
BS EN 46002:1997 - Identical
I.S. EN 46002:1997 - Identical
NF EN 46002:1996 - Identical
SS EN 46002 Ed. 2 (1997) - Identical
