YY/T 0456.1-2003
Replaced
YY/T 1902-2024
Active
Industry standards-Medicine
YY/T 1902-2024 Medical plasma quick freezer
YY/T 1902-2024 Medical plasma quick freezer
Basic Information
Standard Code:
YY/T 1902-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2024-02-07
Implement Date:
2026-03-01
Publisher:
国家药品监督管理局
Technical Committee:
全国测量、控制和实验室电器设备安全标准化技术委员会医用设备分技术委员会(SAC/TC 338/SC 1)
Pages:
16 pages
Scope
本文件规定了医用血浆速冻机(以下简称速冻机)的产品分类、要求,描述了相应的试验方法。本文件适用于医用血浆速冻机。本文件不适用于采用夹合式和风冷式以外其他传热方式的速冻机。
Development Information
Drafting Units:
辽宁省医疗器械检验检测院、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、安徽省食品药品检验研究院、山东省医疗器械和药品包装检验研究院、北京大学第三医院、青岛海尔生物医疗股份有限公司、武汉贝索医疗器械有限公司、郑州飞龙医疗设备有限公司、冰山松洋生物科技(大连)有限公司、中科美菱低温科技股份有限公司
Drafting Persons:
杨艳、王博、冯磊、赵永昕、张克、王冬、矫强、黄艳春、叶小灿、陈海涛、金灿、申彦魁、刘发柱、曲耀辉、袁顺涛、姚本虎、苏嵋华
Referenced Standards
GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements
GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
Related Standards
YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active