DZ/T 0101.12-1994
Active
GB/T 42218-2022
Active
National standards
GB/T 42218-2022 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer
GB/T 42218-2022 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer
Basic Information
Standard Code:
GB/T 42218-2022
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
-
Publish Date:
2022-12-30
Implement Date:
2023-07-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
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:
12 pages
Scope
本文件描述了体外诊断医疗器械制造商对推荐给用户的质量控制程序的确认过程。质量控制程序的作用是为用户提供器械性能与其预期用途以及制造商声明相一致的保证。本文件适用于所有体外诊断医疗器械。
Development Information
Drafting Units:
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)、北京金域医学检验实验室有限公司、首都医科大学附属北京天坛医院、山东艾科达生物科技有限公司、北京中关村水木医疗科技有限公司、北京九强生物技术股份有限公司、北京利德曼生化股份有限公司、北京华科泰生物技术股份有限公司、迪瑞医疗器械科技股份有限公司
Drafting Persons:
杨忠、陈宝荣、张国军、邹迎曙、李健、王军、陈阳、任轶昆、肖燚、常淑芹、陈微
Referenced Standards
ISO 13485
ISO 14971
ISO/IEC 指南99
GB/T 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements
JJF 1001-1998 General Terms in Metrology and Their Definitions
JJF 1001-2011 General Terms in Metrology and Their Definitions
Adopt standards
ISO 15198:2004
Related Standards
JJG 204-1980
Active
JJG 204-1980 Meteorological Ventilation Psychrometer
SC 53-1980
Active
SC 53-1980 Transfer blade hydraulic steering gear repair quality standard
DZ 4-1981
Replaced
DZ 4-1981
SC 69-1982
Active
SC 69-1982 ZSS-12 Flash-type seawater desalination production device technical specifications
SC 72-1982
Active