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Requirements for medical devices to be designated "STERILE"—Part 2:Requirements for aseptically processed medical devices
Standard in brief
Scope of Application：
YY／T 0615的本部分规定了标示“无菌”的无菌加工医疗器械的要求。
注: 医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“无菌”。YY/T 0567规定了无菌加工的确认和常规控制。
Basic information
Standard No：YY/T 0615.2-2007
Standard Name：标示“无菌”医疗器械的要求 第2部分:无菌加工医疗器械的要求
English Name：Requirements for medical devices to be designated "STERILE"—Part 2:Requirements for aseptically processed medical devices
Standard Status：现行
Release Date：2007-07-02
Effective Date：2008-03-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.080.01
CCS Number：C47
Related Standards
Referenced Standards：GB 18278,GB 18279, GB 18280,GB/T 19974-2005,YY/T 0287,ISO 14160:1998,ISO 14937:2000
Adopted Standards：EN 556-2:2003
Adoption Level：IDT
Publication Information
Number of pages：8
Number of words：9 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2007-12-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家食品药品监督管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0615.2
Drafter：吴平、由少华
Drafting Organization：山东省医疗器械产品质量检验中心
Management Organization：国家食品药品监督管理局济南医疗器械质量监督检验中心
Proposing Department：全国医用输液器具标准化技术委员会
