YY/T 1465.7-2021 Active Industry standards-Medicine

YY/T 1465.7-2021 Immunogenic evaluation method of medical devices—Part 7:Liquid phase multiplex protein quantification technique by flow cytometry

Publish Date: 2021-03-09 Implement Date: 2022-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1465.7-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Disinfection and sterilization

Publish Date: 2021-03-09

Implement Date: 2022-04-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)

Pages: 7 pages

Scope

YY/T 1465的本部分规定了利用流式液相多重蛋白定量技术定量检测样本中多种可溶性蛋白的试验方法。
本部分适用于评价医疗器械/材料诱导机体产生的免疫应答。

Development Information

Drafting Units:

山东省医疗器械产品质量检验中心、四川大学(四川医疗器械生物材料和制品检验中心)、北京市医疗器械检验所

Drafting Persons:

王国伟、侯丽、孙晓霞、袁暾、戴政宁、贺学英、蔡永福

Word Count: 12 Thousand words Pages: 7 pages

Referenced Standards

GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements

Related Standards

GB/T 8600-1988 Replaced

GB/T 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer

Publish Date: 1988-01-12

GB 8599-1988 Replaced

GB 8599-1988 Specifications for automated autoclave sterilizer

Publish Date: 1988-01-13

GB 15981-1995 Replaced

GB 15981-1995 Evaluating method and standard for the efficacy of disinfection and sterilization

Publish Date: 1996-01-23

GB 15982-1995 Replaced

GB 15982-1995 Hygienic standard for disinfection in hospitals

Publish Date: 1996-01-23

GB 16383-1996 Replaced

GB 16383-1996 Quality control standards for radiation sterilization of medical and hygienical products

Publish Date: 1996-05-23

GB 18279-2000 Replaced

GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization

Publish Date: 2000-12-13