YY/T 0606.14-2014 Active Industry standards-Medicine

YY/T 0606.14-2014 Tissue engineered medical products—Part 14:Standard practice for evaluation of immune responses of substrate and scaffolds products:ELISA tests

YY/T 0606.14-2014 Tissue engineered medical products—Part 14:Standard practice for evaluation of immune responses of substrate and scaffolds products:ELISA tests

Publish Date: 2014-06-17 Implement Date: 2015-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0606.14-2014
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2014-06-17
Implement Date: 2015-07-01
Pages: 7 pages

Scope

This part of YY/T 0606 specifies the test method for evaluating the immune response of mammalian body fluids induced by the matrix or scaffold of tissue engineering medical products: the ELISA method.
This part is applicable to the biological evaluation of the matrix or scaffold of tissue engineering medical products.

Development Information

Word Count: 9 Thousand words Pages: 7 pages

Same series standard

Referenced Standards

ISO/TS 10993.20 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 YY/T 0606.3-2007 Tissue engineered medical products—Part 3:General classification YY/T 0606.5-2007 Tissue engineered medical Products—Part 5:Characterization and testing of substrates and scaffolds

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