DS DS/EN ISO 13488
DS DSEN SO 13488 2001-FEB-09 Qualty systems - Medcal devces - Partcular requrements for the applcaton of EN SO 9002 Replaced by DS DSEN SO 13485
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The standard specifies, in conjunction with ISO 9002, the quality system requirements for the production and, when relevant, installation of medical devices. This standard, in conjuntion with ISO 9002, is applicable when there is a need to assess a medical device supplier's quality system.