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Implants for surgery—Two-part addition-cure silicone elastomers
Standard in brief
Scope of Application:
本标准规定了生产(部分或全部)外科植入物用双组分加成型硫化高粘稠或液体硅橡胶的特性和相应的试验方法
Basic information
Standard No:YY/T 0484-2004
Standard Name:外科植入物 双组分加成型硫化硅橡胶
English Name:Implants for surgery—Two-part addition-cure silicone elastomers
Standard Status:现行
Release Date:2004-07-16
Effective Date:2005-08-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.40
CCS Number:C48
Related Standards
Referenced Standards:GB/T 529-1999,GB/T 6031-1998,GB/T 9869-1997,GB/T 16584-1996,GB/T 16886.1-2001,GB/T 16886.5-2003,ISO 527-2:1993
Adopted Standards:ISO 14949:2001
Adoption Level:IDT
Publication Information
Number of pages:16
Number of words:22 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2004-10-01
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:0484
Drafter:施燕平、吴平
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: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