YY/T 1435-2016Tissue engineering medical device products—Standard guide for characterization of hydrogels (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

The hydrogel is a reticular polymer that swells in water and retains moisture in the polymer voids. Due to the existence of intermolecular crosslinking, hydration The glue can maintain a stable structure in the solid after swelling. The hydrogel material used in tissue engineering can be derived from natural polymers (e.g., algae Acid, chitosan and collagen), synthetic polymers [e.g., polyethylene glycol (PEG), polyvinyl alcohol (PVA)] or a mixture of both (e.g., PVA and Chitosan or gelatin). In clinical applications, hydrogels with or without the addition of a drug and/or a biological agent may be injected or implanted in the body.

Hydrogels are used primarily in tissue engineering as transport carriers for matrix substitutes, drugs and/or preparations, and environments that make up cell culture.

In the course of the application, the effect of the hydrogel depends on its ability to allow the dissolved gas, nutrients and bioactive substances to penetrate Ability to maintain cell growth and migration; ability to degrade; ability to release drugs and/or biological agents at a suitable rate;

1 Scope

This standard gives the biological properties of hydrogels used to characterize tissue engineering medical device products, forming kinetics, physical and chemical Sexuality and stability, as well as material delivery and other characteristics of the method guide.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (GB/T 16886.1-2011, ISO 10993-1.:2009, IDT) A gel having a three-dimensional network structure formed by a polymer chain and retaining moisture in the intermolecular voids.

GB/T 16886.19 Biological evaluation of medical devices - Part 19. Physical chemistry, morphology and surface characterization of materials (GB/T 16886.19-2011, ISO /T S10993-19..2006, IDT)

Tissue engineering medical products - Part 5. Performance and testing of substrates and stents YY/T 0606.5 Tissue engineering medical products - Part 7. Chitosan Tissue engineering medical products - Part 8. Sodium alginate Tissue engineering medical products - Part 9. Sodium hyaluronate

YY/T 0771.1 Animal source medical devices - Part 1. Risk management applications (YY/T 0771.1-2009, ISO 22442-1. 2007, IDT) Pharmacopoeia of the People's Republic of China (2010 edition)

3 Terms and definitions

The following terms and definitions apply to this document.