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YY/T 0606.14-2014Tissue engineered medical products - Part 14: Standard practice for evaluating the immune response of matrices and scaffolds - ELISA method (English PDF)

组织工程医疗产品第14部分：评价基质及支架免疫反应的试验方法：ELISA法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 0606.14-2014 is the English-translated version of 组织工程医疗产品第14部分：评价基质及支架免疫反应的试验方法：ELISA法.

YY/T 0606.14-2014 is the Chinese standard "Tissue engineered medical products - Part 14: Standard practice for evaluating the immune response of matrices and scaffolds - ELISA method".

Its scope clause reads: YY/T 0606 provisions of this part of the test due to a mammal a humoral immune response evaluation of tissue-engineered medical products matrix or scaffold Test method.

ELISA method. This section applies to biological evaluation of medical products for tissue engineering scaffold or matrix. NOTE. This standard may also be used, although the test to detect human specimens or for research purposes, and provides data for clinical track, but not on the human body shape Diagnostic testing conditions.

In addition to this part of the selected method, but may adopt other equivalent method.

Not all materials and applications are required in accordance with this section for detection and therefore should carefully consider the applicability of the method in this section. in Before the implementation of this part of the recommended test, the test results should be considered GB/T 16886.1 or administration recommended the prompt information. Its clauses include terms and definitions.

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Document preview — YY/T 0606.14-2014

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C45

Issued by: National Medical Products Administration

1 Scope
2 Normative references
3 Terms and Definitions
3.1 Matrix substrate
3.2 Bracket scaffold

1 Scope

YY/T 0606 provisions of this part of the test due to a mammal a humoral immune response evaluation of tissue-engineered medical products matrix or scaffold

Test method. ELISA method.

This section applies to biological evaluation of medical products for tissue engineering scaffold or matrix.

NOTE. This standard may also be used, although the test to detect human specimens or for research purposes, and provides data for clinical track, but not on the human body shape

Diagnostic testing conditions.

In addition to this part of the selected method, but may adopt other equivalent method.

Not all materials and applications are required in accordance with this section for detection and therefore should carefully consider the applicability of the method in this section. in

Before the implementation of this part of the recommended test, the test results should be considered GB/T 16886.1 or administration recommended the prompt information.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein

Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing

Tests for local effects after implantation. GB/T 16886.6 Biological evaluation of medical devices - Part 6

GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test

GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials

YY/T 0606.3 tissue-engineered medical products - Part 3. General Category

YY/T 0606.5 tissue-engineered medical products - Part 5. Matrix and stent performance and testing

ISO /T S10993.20 Biological evaluation of medical devices - Part 20. Immune toxicology test principles of medical devices and methods (Bio- logicalevaluationofmedicaldevices-Part 20. Principlesandmethodsforimmunotoxicologytestingof medicaldevices)

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Matrix substrate

Tissue-engineered medical products as the growth of cells or biomolecules, support or delivery vehicle of raw materials.

3.2 Bracket scaffold

Alternative, repair or regeneration of tissue cells or biologically active factors migration, binding or transporting a support, carrier or matrix release.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

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