【优质】中国医疗器械年会教材RevisedChinaCAMDIYichang-Ikeda-2015March(chinese)V1中英文对照版.pptVIP

PARTeamFacilPlanApril2202 Medical Packaging Standards医疗包装标准 Ichiro Ikeda 池田一郎 Regional Regulatory Affairs Manager 亚太区法规事务经理 DuPont Protection Technology 杜邦防护科技 Overview 概览 Global Medical Packaging Standards全球医疗包装标准 ISO EN 11607 Global Status 全球顺应现状 (1/2) ISO EN 11607 Global Status 全球顺应现状 (2/2) Compliance 符合 Must meet the requirements dictated by every “Shall” statement 必须符合标准中所指示的每个“应该”的要求 ISO EN 11607-1 has eighty-two “shall” statements 第1部分有82个“应该”的规定 ISO EN 11607-2 has forty-eight “shall statements 第2部分有48个“应该”的规定 Eleven of these “shall” statements are identical in the two documents 其中11