YY/T 1435-2016 in English

VALID

Tissue engineering medical device products―Standard guide for characterization of hydrogels

Issued on:2016-07-29
Implemented on:2017-06-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $220.00
$214.00

Standard No:	YY/T 1435-2016
Document status:	VALID
Title in English:	Tissue engineering medical device products―Standard guide for characterization of hydrogels
Title in Chinese:	组织工程医疗器械产品水凝胶表征指南
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2016-07-29
Implemented on:	2017-06-01
ICS Classification:	11.040.40-Implants for surgery, prosthetics and orthotics
Chinese Classification:	C45-Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	YY-Pharmaceutics
Related Keywords:	tissue engineering devices tissue engineering medical device products hydrogels introductionthis standard ― standard guide
Related Topics:	Hydrogel+ aqueous gel Medical device products Hydrogel Characterization Medical device products Characterize the product Characterization of Hydrogels Characterization of gels gelation index Gel Characterization Gel Characterization gelation index product gel Hydrogel + Characterization Medical Device Product Standards Class II medical device products water in hydrogel How to Measure Tissue Engineering Characterize the final product Cutting-edge technologies and products of medical devices Animal Tissues for Medical Devices Tissue Engineering Medical Device Products Medical electrical products Medical device product effectiveness Tissue baking machine is a medical device Moisturizing test of medical device products Conventional characterization methods for hydrogels Medical glue quality Execution of medical silicone products Hydrogel modulus characterization method

本标准规定了用于表征水凝胶生物学特性、形成动力学、物理与化学特性及稳定性，以及物质传递等特性的方法指南。本标准适用于在再生医学和组织工程中用作基质替代物、药物和/或制剂输送载体或细胞培养基质的水凝胶。

Introduction

This standard provides guidance on the characterization of hydrogel materials used in tissue engineering medical devices. It outlines methods for evaluating the physical and chemical properties of hydrogels, including their structure, mechanical behavior, and degradation characteristics. The document also addresses the testing procedures for assessing the biological compatibility and performance of these materials in medical applications. Additionally, it includes recommendations for the selection and use of appropriate analytical techniques to ensure the consistency and reliability of hydrogel products. The standard aims to support manufacturers and regulatory bodies in the development and evaluation of tissue engineering devices containing hydrogel components.

*** Please note: This description may not be accurate, please refer to the official documentation.

More samples: NB/T 47013.2-2015 DL/T 368-2010 QC/T 942-2021

Sample only — not a preview of YY/T 1435-2016

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