YY/T 0456.1-2003
Replaced
YY/T 0086-2020
Active
Industry standards-Medicine
YY/T 0086-2020 Medical refrigerator
YY/T 0086-2020 Medical refrigerator
Basic Information
Standard Code:
YY/T 0086-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2020-02-21
Implement Date:
2022-01-01
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/SC1)
Pages:
19 pages
Scope
本标准规定了医用冷藏箱的术语和定义、产品分类、要求、试验方法、标志、包装、运输、贮存。
本标准适用于箱内温度范围为2 ℃~8 ℃，由工厂装配，采用电机驱动压缩机方式制冷，内部采用空气自然对流或强制对流方式进行冷却的用于存放存品的医用冷藏箱（以下简称冷藏箱），包括医用血液冷藏箱（以下简称血液冷藏箱）。
Development Information
Drafting Units:
辽宁省医疗器械检验检测院、青岛海尔生物医疗股份有限公司、松下冷链(大连)有限公司、北京市医疗器械检验所、山东省食品药品监督管理局审评认证中心
Drafting Persons:
王博、刘占杰、牛愉涛、崔节慧、刘发柱、金野、梁振士、冯磊、张一
Replace the following standards
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