YY/T 0606.15-2023 Active Industry standards-Medicine

YY/T 0606.15-2023 Tissue engineered medical products—Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests

YY/T 0606.15-2023 Tissue engineered medical products—Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests

Publish Date: 2023-01-13 Implement Date: 2024-01-15 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 0606.15-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical optical instruments and equipment, and endoscopes

ICS Name: Surgical instruments and materials

Publish Date: 2023-01-13

Implement Date: 2024-01-15

Pages: 11 pages

Scope

This document specifies a test method for evaluating the immune response of mammalian cells to matrices or scaffolds used in tissue engineering medical products: the lymphocyte proliferation assay.
This document is applicable to the biological evaluation of matrices or scaffolds used in tissue engineering medical products.
Note: Methods other than those selected in this document may be adopted if they are equivalent.

Development Information

Word Count: 24 Thousand words Pages: 11 pages

Replace the following standards

YY/T 0606.15-2014 Tissue engineered medical products—Part 15:Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests

Referenced Standards

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization 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

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