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Medical carboxymethylchitosan
Standard in brief
Scope of Application:
本标准规定了医用羧甲基壳聚糖原料的要求、试验方法、检验规则、包装、运输、贮存等要求。
本标准适用于以壳聚糖或甲壳素为原料,经脱乙酰化、羧化、纯化而制成的医用级羧甲基壳聚糖,用于医疗器械产品。
Basic information
Standard No:YY 0953-2015
Standard Name:医用羧甲基壳聚糖
English Name:Medical carboxymethylchitosan
Standard Status:现行
Release Date:2015-03-02
Effective Date:2017-01-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.30
CCS Number:C35
Related Standards
Referenced Standards:GB/T 191,GB/T 9969,GB/T 14233.2,GB/T 16886.1,GB/T 16886.3,GB/T 16886.5,GB/T 16886.6,GB/T 16886.10,GB/T 16886.11,GB/T 16886.12,GB/T 16886.13-2001,GB/T 16886.17,GB 18279-2000,YY/T 0313,YY/T 0466.1,YY/T 0771.1,YY/T 0771.2,YY/T 0771.3,中华人民共和国药典(二部)2010年版
Publication Information
Number of pages:28
Number of words:38 K
Format:大16
Edition:2
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2019-12-01
Standard Revision Information
Has Amendment:Yes
Amendment Note:有第1号修改单
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:0953
Drafter:付步芳、顾其胜、蒋丽霞、卢大伟、周贵、黄元礼、冯晓明、王春仁
Drafting Organization:中国食品药品检定研究院、上海其胜生物制剂有限公司
Management Organization:中国食品药品检定研究院
Proposing Department:国家食品药品监督管理总局