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YY/T 1574-2017Tissue engineering medical device products - Standard guide for immobilization or encapsulation in alginate gels (English PDF)

组织工程医疗器械产品海藻酸盐凝胶固定或微囊化指南

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

August 18, 2017

Implementation date

September 1, 2018

Scope

YY/T 1574-2017 is the English-translated version of 组织工程医疗器械产品海藻酸盐凝胶固定或微囊化指南.

YY/T 1574-2017 is the Chinese standard "Tissue engineering medical device products - Standard guide for immobilization or encapsulation in alginate gels".

Its scope clause reads: This standard specifies the alginate gel immobilization or microencapsulation evaluation requirements, including alginate gel immobilization or microencapsulation, microcapsules or Study on the Properties and Investigation of Micro-bead and the Biocompatibility of Alginate Gel.

This standard applies to alginate gel immobilization or microencapsulation evaluation. Its clauses include terms and definitions.

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Document preview — YY/T 1574-2017

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 45

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 Normative references
3 Terms and definitions
4 Meaning and purpose
5 alginate gel immobilization or microencapsulation
6 Performance of microcapsules or microbeads
7 Alginate gel biocompatibility
Appendix A (Normative) Preparation of alginate beads for immobilization or microencapsulation of living cells or tissues
Appendix B (Normative) Microcapsule morphology, size and distribution of particle size determination
Appendix C (Normative) Determination of microcapsule porosity
Appendix D (Normative) Diffusion of microcapsules Determination
Appendix E (Normative) Microcapsule drying determination
Appendix F (Normative) Determination of mechanical strength of microcapsules
References

1 Scope

This standard specifies the alginate gel immobilization or microencapsulation evaluation requirements, including alginate gel immobilization or microencapsulation, microcapsules or

Study on the Properties and Investigation of Micro-bead and the Biocompatibility of Alginate Gel.

This standard applies to alginate gel immobilization or microencapsulation evaluation.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article

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

GB 16352 disposable medical supplies gamma-ray radiation sterilization standards

GB 18278.1 health care products sterilization damp heat Part 1. Medical device sterilization process development, validation and general control requirements

GB 18281 (all parts) Sterilization bio-indicators for healthcare products [ISO 11138 (all parts)]

Biological evaluation of medical devices - Part 4. Choice of tests for interaction with blood (ISO 10993..2004).

2002, IDT)

GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (ISO 10993.5.1999,

IDT)

GB/T 16886.11-2011 Biological evaluation of medical devices - Part 11. Systemic toxicity test (ISO 10993.11-2006,

IDT)

Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (ISO 10993.12.

2002, IDT)

YY/T 0606.8 Tissue engineering medical products - Part 8. Sodium alginate

Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Alginate

A polysaccharide extracted from common seaweed that forms insoluble mixtures with calcium, magnesium, sodium or potassium salts. Alginate comes from

In brown algae, which is the most abundant polysaccharide in brown algae, it is mainly found in the cell walls and intercellular spaces of seaweed and seaweed, and its main function is

Maintain seaweed strength and toughness. Alginates can be classified as hydrocolloids. The most commonly used alginate is sodium alginate.

3.2 APA microcapsules APAbead

Alginate-poly-L-lysine-alginate microbeads.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Normative references

GB 16352 · GB 18281

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