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GB/T 19701.5-2024 English PDF

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US$199.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 19701.5-2024: Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 19701.5-2024	199	Add to Cart	3 days	Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method	Valid

Similar standards

GB/T 19701.1 GB 23101.2 GB 23101.4 GB/T 12417.2 GB/T 19701.3 GB/T 19701.2

Basic data

Standard ID: GB/T 19701.5-2024 (GB/T19701.5-2024)
Description (Translated English): Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 10,174
Date of Issue: 2024-11-28
Date of Implementation: 2025-12-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 19701.5-2024: Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method

---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.
ICS 11.040.40 CCSC35 National Standard of the People's Republic of China Ultra-high molecular weight polyethylene for surgical implants Part 5.Morphological evaluation methods (ISO 5834-5.2019,MOD) Released on 2024-11-28 2025-12-01 Implementation State Administration for Market Regulation The National Standardization Administration issued

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Test methods 4 References 5

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 for standardization documents" Drafting. This document is part 5 of GB/T 19701 Ultra-high molecular weight polyethylene for surgical implants. GB/T 19701 has been published The following parts. --- Part 1.Powders; --- Part 2.Moulding materials; --- Part 3.Accelerated aging methods; --- Part 5.Morphological evaluation method. This document is modified to adopt ISO 5834-5.2019 "Ultra-high molecular weight polyethylene for surgical implants - Part 5.Morphological evaluation methods". The technical differences between this document and ISO 5834-5.2019 and their reasons are as follows. --- The normative reference GB/T 21461.1 replaces ISO 11542-1 (see Chapter 3) to adapt to my country's technical conditions and provide High operability; --- ISO 11542-2 (see Chapter 3) has been replaced by the normative reference GB/T 21461.2 to adapt to my country's technical conditions and provide High operability; --- Changed the observation method of microscope in the test method (see 4.2.2, 4.2.2 of ISO 5834-5.2019), and the terminology and definition The test conditions are consistent with those given in the specification. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Antong Yitai Medical Technology Co., Ltd., Stryker (Beijing) Medical Equipment Co., Ltd. The main drafters of this document are. Jiang Xi, Zhang Haocheng, An Junbo, Cui Hong, Hu Zhijie, Bao Qi, Gao Chunyu and Wang Anna.

Introduction

Ultra-high molecular weight polyethylene has good mechanical properties, wear resistance and biocompatibility, and is widely used in surgical implants such as artificial joints, Widely used in tissue stent products. GB/T 19701 "Ultra-high molecular weight polyethylene for surgical implants" is planned to consist of 5 parts. --- Part 1.Powders. The purpose is to standardize the requirements and corresponding tests of ultra-high molecular weight polyethylene powders for surgical implants method. --- Part 2.Moulding materials. The purpose is to specify the requirements and related The method should be tested. --- Part 3.Accelerated aging method. The purpose is to provide ultra-high molecular weight polyethylene (UHMWPE) materials for surgical implants Test method for oxidative stability during processing and sterilization. --- Part 4.Oxidation index test method. The purpose is to provide a test method for the relative oxidation degree of ultra-high molecular weight polyethylene. Evaluation of the relative degree of oxidation of ultra-high molecular weight polyethylene. --- Part 5.Morphological evaluation method. The purpose is to provide a test method for the morphological quality of ultra-high molecular weight polyethylene molding compounds to evaluate Relative cured quality (morphology) of ultra-high molecular weight polyethylene molding compounds. Ultra-high molecular weight polyethylene for surgical implants Part 5.Morphological evaluation methods

1 Scope

This document describes the morphological evaluation of ultra-high molecular weight polyethylene (PE-UHMW) molding compounds as defined in GB/T 19701.2. Test method. This document does not apply to ultra-high molecular weight polyethylene (PE-UHMW) powder described in GB/T 19701.1. NOTE. Performance requirements for this test method have not yet been established.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 21461.1 Plastics Ultra-high molecular weight polyethylene (PE-UHMW) molding and extrusion materials Part 1.Nomenclature system and Classification basis (GB/T 21461.1-2023, ISO 21304-1.2019, MOD) GB/T 21461.2 Plastics Ultra-high molecular weight polyethylene (PE-UHMW) molding and extrusion materials Part 2.Sample preparation and Performance measurement (GB/T 21461.2-2023, ISO 21304-2.2021, MOD)

3 Terms and definitions

The terms and definitions defined in GB/T 21461.1, GB/T 21461.2 and the following apply to this document. The terminology databases used for standardization maintained by ISO and IEC are located at. 3.1 A typeA non-fused flake Visible under the conditions described in 4.2.2, with a black, gap-like border with a substantially complete circumference and a white center. Note. See Figure 1. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 19701.5-2024_English be delivered?

Answer: Upon your order, we will start to translate GB/T 19701.5-2024_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 GB/T 19701.5-2024_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 19701.5-2024_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.