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YY/T 1806.1-2021 English PDF

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US$179.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1806.1-2021: (Evaluation method for in vitro degradation performance of biomedical materials - Part 1: Degradable polyesters)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1806.1-2021	179	Add to Cart	3 days	(Evaluation method for in vitro degradation performance of biomedical materials - Part 1: Degradable polyesters)	Valid

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Basic data

Standard ID: YY/T 1806.1-2021 (YY/T1806.1-2021)
Description (Translated English): (Evaluation method for in vitro degradation performance of biomedical materials - Part 1: Degradable polyesters)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Word Count Estimation: 8,860
Issuing agency(ies): State Drug Administration

YY/T 1806.1-2021: (Evaluation method for in vitro degradation performance of biomedical materials - Part 1: Degradable polyesters)

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Evaluation method for in vitro degradation performance of biomedical materials. Part 1.Degradable polyesters) ICS 11.040.01 CCSC30 People's Republic of China Pharmaceutical Industry Standard Evaluation method for in vitro degradation performance of biomedical materials Part 1.Degradable polyesters Part 1.Degradablepolyester 2022-09-01 Implementation Released by the State Drug Administration

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. This document is part 1 of YY/T 1806 "Methods for Evaluation of In Vitro Degradation Properties of Biomedical Materials". YY/T 1806 has been released the following parts. --- Part 1.Degradable polyesters; --- Part 2.Mussel mucin. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248). This document is drafted by. Shandong Medical Device Product Quality Inspection Center, Shanghai MicroPort Medical Devices (Group) Co., Ltd., Shanghai Song Force Biotechnology Co., Ltd. The main drafters of this document. Du Fuying, Peng Jian, Jiang Hongyan, Liu Danyang, Zhang Huamei, Kang Yahong, Yin Rongxin.

Introduction

Degradable polyester is a kind of chemically synthesized polymer biomaterial with good biodegradability and biocompatibility. required biomedical materials. Its degradation behavior includes degradation rate, product formation, morphology, and mechanical properties changes during the degradation process. Product safety and efficacy are closely related. Degradable polyesters may be homopolymers, copolymers or blends, and the degradation principle is mainly the hydrolysis of ester bonds. Types of materials, chemical groups The composition, structure, configuration, molecular chain length, crystallinity, physical morphology (thickness, pores), etc. are all internal factors that affect the degradation rate. In addition, the environment Temperature, humidity, pH of test solution, ratio of sample to test solution, etc. will also affect its in vitro degradation. establish a suitable method for The evaluation of the in vitro degradation behavior of degradable polyester raw materials or final products can provide data support for material modification and process optimization. Due to the variety and application of degradable polyester medical materials, this document cannot give specific tests applicable to all materials. method. When conducting in vitro degradation studies of specific products, this document can be referred to when applicable. In addition to the methods recommended in this document Other methods can also be used, but the user of this document is responsible for proper demonstration before use to ensure that the method is feasible and reliable. YY/T 1806 aims to establish a method for evaluating the in vitro degradation performance of biomedical materials, and is intended to consist of two parts. --- Part 1.Degradable polyesters. The purpose is to evaluate the in vitro degradation performance of degradable polyester biomedical materials/devices. price method. --- Part 2.Mussel mucin. The purpose is to evaluate the in vitro degradation performance of mussel mucin biomedical materials/devices method. Evaluation method for in vitro degradation performance of biomedical materials Part 1.Degradable polyesters

1 Scope

This document specifies the degradation principle of glycolide, lactide, ε-caprolactone and other homopolymers, copolymers or blends whose degradation principle is mainly hydrolysis of ester bonds. Methods for evaluating the degradation properties of biomedical materials/devices. This document is applicable to the evaluation of in vitro degradation performance of degradable polyester biomedical materials/devices.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB/T 1632.1 Plastics use capillary viscometer to determine the viscosity of dilute polymer solutions - Part 1.General GB/T 6682 Analysis Laboratory Water Specifications and Test Methods Pharmacopoeia of the People's Republic of China (four volumes of the 2020 edition)

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 In vitro degradation invitrodegradation Degradation that occurs in a simulated physiological environment. 3.2 homopolymer A polymeric material composed of a structural unit. 3.3 copolymer A polymeric material composed of two or more structural units. 3.4 blend blend A polymeric material composed of two or more homopolymers or copolymers mixed together.

4 In vitro degradation test design

4.1 Overview Place an appropriate amount of sample in a container, cover it with the test solution and seal the container to maintain a suitable temperature. During different periods of the test, from the test The test sample was taken out of the test solution for the evaluation of the degradation performance of the material. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1806.1-2021_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1806.1-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1806.1-2021_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1806.1-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.