YY/T 1465.5-2016 Active Industry standards-Medicine

YY/T 1465.5-2016 Immunogenic evaluation method of medical devices—Part 5:Determination of α-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibody

YY/T 1465.5-2016 Immunogenic evaluation method of medical devices—Part 5:Determination of α-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibody

Publish Date: 2016-07-29 Implement Date: 2017-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1465.5-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical materials

Publish Date: 2016-07-29

Implement Date: 2017-06-01

Pages: 12 pages

Scope

This part of YY/T 1465 provides a method for determining the removal rate of alpha-Gal antigens in animal-derived medical devices, which is suitable for evaluating the effectiveness of the alpha-Gal antigen removal process.
The method in this part is applicable to materials that can fully expose alpha-Gal antigens through grinding. If the alpha-Gal antigens cannot be fully exposed through grinding, other confirmed suitable methods may be considered.
Note: Appendix A provides an example of the evaluation method of immunohistochemistry.

Development Information

Word Count: 20 Thousand words Pages: 12 pages

Same series standard

YY/T 1465.1-2016 Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro YY/T 1465.2-2016 Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay) YY/T 1465.3-2016 Immunogenic evaluation method of medical devices—Part 3:Plaque forming cells assay—Agar gel solid-phase method

Referenced Standards

中国药典　2010版 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 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements

Related Standards

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