GB 8662-1988
Replaced
YY/T 1214-2019
Active
Industry standards-Medicine
YY/T 1214-2019 Human chorionic gonadotrophin detection kit
YY/T 1214-2019 Human chorionic gonadotrophin detection kit
Basic Information
Standard Code:
YY/T 1214-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2019-07-24
Implement Date:
2020-08-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
Pages:
7 pages
Scope
本标准规定了人绒毛膜促性腺激素测定试剂盒的分类、要求、试验方法、标签和使用说明书、包装、运输、贮存。本标准适用于以双抗体夹心法为原理定量测定人绒毛膜促性腺激素的试剂盒，包括以酶标记、(电)化学发光标记、(时间分辨)荧光标记等标记方法的免疫分析试剂盒。本标准不适用：用胶体金或其他方法标记的半定量测定人绒毛膜促性腺激素的试剂(如：试纸条等)；用125I等放射性同位素标记的各类人绒毛膜促性腺激素放射免疫或免疫放射试剂盒。
Development Information
Drafting Units:
中国食品药品检定研究院、罗氏诊断产品(上海)有限公司、西门子医学诊断产品(上海)有限公司、雅培贸易(上海)有限公司
Drafting Persons:
于婷、黄颖、曲守方、孙楠、黄杰、蔡晓蓉、葛亚文、汪少颖、肖璐、王雪峰、张弘
Replace the following standards
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced