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0 序言 EN ISO 9002指在成为规定质量体系要求的一项通用标准。EN 46002为医疗器械供应商提供比EN ISO 9002规定的一般要求更加具体的特殊要求。
0 INTRODUCTION EN ISO 9002 refers to a common standard required to be a required quality system. EN 46002 provides medical device suppliers with specific requirements that are more specific than the general requirements of EN ISO 9002.