DS DS/EN 46001
DS DSEN 46001 1999-MAY-20 Qualty systems - Medcal devces - Partcular requrements for the applcaton of DSEN SO 9001 Replaced by DS DSEN SO 13485
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The standard specifies, in conjunction with EN ISO 9001, the quality system requirements for the design/development, production, and where relevant, installation of medical devices.