2保质期加速老化测试AATesting分析.ppt

ACCELERATED AGING PROTOCOL;Agenda;Introduction;Scope;Significance and Use;Accelerated Aging Theory;Accelerated Aging Rationale European Community Council Directive 93/42/EEC, ANNEX 1, “Essential Requirements” states… “The label must bear the following particulars... where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month.”;Accelerated Aging Rationale ISO 11607 states… “For medical devices with a defined shelf-life, the manufacturer shall have documented evidence that the performance of the packaging is not adversely affected