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GB/T 19701.2-2024: Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
Status: Valid GB/T 19701.2: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 19701.2-2024 | English | 199 |
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Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
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GB/T 19701.2-2024
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| GB/T 19701.2-2016 | English | 190 |
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Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 2: Moulded forms
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GB/T 19701.2-2016
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| GB/T 19701.2-2005 | English | 90 |
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Implants for surgery Ultra-high molecular weight polyethylene -- Part 2: Moulded forms
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GB/T 19701.2-2005
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PDF similar to GB/T 19701.2-2024
Basic data | Standard ID | GB/T 19701.2-2024 (GB/T19701.2-2024) | | Description (Translated English) | Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,114 | | Date of Issue | 2024-11-28 | | Date of Implementation | 2025-12-01 | | Older Standard (superseded by this standard) | GB/T 19701.2-2016 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 19701.2-2024: Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
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ICS 11.040.40
CCSC35
National Standard of the People's Republic of China
Replaces GB/T 19701.2-2016
Ultra-high molecular weight polyethylene for surgical implants
Part 2.Moulding compounds
(ISO 5834-2.2019,MOD)
Released on 2024-11-28
2025-12-01 Implementation
State Administration for Market Regulation
The National Standardization Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Categories 1
5 Materials 1
6 Manufacturing Requirements 1
7 Requirement 2
8 Test methods 2
9 Mark 3
10 Test Report 3
11 Tags 3
References 4
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 2 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 replaces GB/T 19701.2-2016 "Ultra-high molecular weight polyethylene for surgical implants Part 2.Moulding materials" and
Compared with GB/T 19701.2-2016, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Deleted the requirements for ash content and its test method (see Table 1 and 7.3 of the.2016 edition);
--- Changed the requirements for tensile stress at break and elongation at break for Type 1 and Type 2 ultra-high molecular weight polyethylene molding compounds (see Table 1,
Table 1 of the.2016 edition).
--- Deleted the requirements and test methods for double notch impact strength (see Table 1 and 7.7 of the.2016 edition);
--- The calculation method of sampling area for particulate matter has been changed (see 8.5, 7.8 of the.2016 edition).
This document is modified to adopt ISO 5834-2.2019 "Ultra-high molecular weight polyethylene for surgical implants - Part 2.Moulding compounds".
The technical differences between this document and ISO 5834-2.2019 and their reasons are as follows.
--- ISO 5834-1 (see Chapter 4 and Chapter 5) has been replaced by the normative reference GB/T 19701.1 to adapt to the technical requirements of my country.
Improve operability;
--- Changed the clauses of 8.1 test conditions involving state adjustment from "8.2~8.5" to "8.2~8.4", 8.5 the sampling of particulate matter
The above-mentioned state adjustment is not required before the sample area test.
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, State Drug Administration Medical Device Technical Review and Inspection
Greater Bay Area Branch, Beijing Antong Yita Medical Technology Co., Ltd., and Beijing Mengtaiyin Medical Equipment Co., Ltd.
The main drafters of this document are. Jiang Xi, Cheng Jianyu, Yin Ziheng, Cui Hong, Liu Bin, Gao Jintao, Hu Zhijie, Tian Jili, Xu Zhiyong, Chen Wenjun.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2005 as GB/T 19701.2-2005, first revised in.2016;
---This is the second revision.
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 scaffold products.
GB/T 19701 "Ultra-high molecular weight polyethylene for surgical implants" is planned to consist of five 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.Morphology evaluation method. The purpose is to provide a morphology quality test method for ultra-high molecular weight polyethylene molding compounds to evaluate
Relative cure qualities (morphology) of ultra-high molecular weight polyethylene molding compounds.
Ultra-high molecular weight polyethylene for surgical implants
Part 2.Moulding compounds
1 Scope
This document specifies the requirements for ultra-high molecular weight polyethylene (PE-UHMW) moulding compounds (e.g. sheets, rods) for surgical implants.
The corresponding test methods were developed.
This document applies to ultra-high molecular weight polyethylene (PE-UHMW) molding compounds.
This document does not apply to directly molded (near final form) products, irradiated products or finished products, nor does it apply to products containing
Products made from polyethylene with additives or blends of different types of polyethylene.
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 19701.1 Ultra-high molecular weight polyethylene for surgical implants Part 1.Powders (GB/T 19701.1-2024, ISO 5834-1.
2019,MOD)
ISO 1183-1 Plastics - Determination of density of non-cellular plastics - Part 1.Immersion method, pycnometer method and titration method
Note. GB/T 1033.1-2008 Plastics - Determination of density of non-cellular plastics - Part 1.Immersion method, liquid pycnometer method and titration method (ISO 1183-1.
2004, IDT)
3 Terms and definitions
There are no terms or definitions that require definition in this document.
4 Categories
The materials for powder molding of Type 1, Type 2 and Type 3 defined in GB/T 19701.1 are divided into Type 1, Type 2 and Type 3 molding compounds accordingly.
5 Materials
The molding compound should be molded from PE-UHMW powder that meets the requirements of GB/T 19701.1.
6 Manufacturing requirements
Each molding compound order should be traceable back to its manufacturing process, such as batch number.
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