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

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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

Pages: 7 pages

Scope

This part of YY/T 1465 specifies the test method for quantitatively detecting multiple soluble proteins in samples using flow cytometry-based multiplex protein quantification technology.
This part is applicable to evaluating the immune response induced by medical devices/materials in the body.

Development Information

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

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