This standard is the Chinese version electronic standard. After you successfully purchase, we will send the electronic version of this standard to your email address. If you have any question, please contact email: ChineseStandardsLibraryS001@gmail.com.
Requirements for the development,validation and routine control of dry heat sterilization process for medical devices
Basic information
Standard No：YY/T 1276-2016
Standard Name：医疗器械干热灭菌过程的开发、确认和常规控制要求
English Name：Requirements for the development,validation and routine control of dry heat sterilization process for medical devices
Standard Status：现行
Release Date：2016-03-23
Effective Date：2017-01-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.080.01
CCS Number：C47
Related Standards
Referenced Standards：ISO 10012,ISO 10993-1,ISO 10993-17,ISO 11138-1:2006,ISO 11138-4:2006,ISO 11140-1:2005,ISO 11607-1,ISO 11607-2,ISO 11737-1,ISO 11737-2,ISO 13485:2003,IEC 61010-1,IEC 61010-2-040
Adopted Standards：ISO 20857:2010
Adopted Standard Name：《医疗保健产品灭菌 干热 医疗器械灭菌过程的开发、确认和常规控制要求》(英文版)
Adoption Level：IDT
Publication Information
Number of pages：52
Number of words：90 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2016-08-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家食品药品监督管理总局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：1276
Drafter：刘永保、邱纬宇、王洪敏、胡昌明、朱晓明
Drafting Organization：山东新华医疗器械股份有限公司、国家食品药品监督管理局广州医疗器械质量监督检验中心
Management Organization：全国消毒技术与设备标准化技术委员会(SAC/TC 200)
Proposing Department：国家食品药品监督管理总局
