DS DS/EN 46003
DS DSEN 46003 1999-SEP-13 Qualty systems - Medcal devces - Partcular requrements for the applcaton of EN SO 9003 Replaced by DS DSEN SO 13485
DS DSEN 46003 1999-SEP-13 Qualty systems - Medcal devces - Partcular requrements for the applcaton of EN SO 9003 Replaced by DS DSEN SO 13485
This standard specifies, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical devices supplier's quality system is assessed in accordance with regulatory requirements.