GB/T 19701.1-2024 PDF English
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GB/T 19701.1: Historical versions
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| GB/T 19701.1-2024 | 215 | Add to Cart | Auto, 9 seconds. | Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form | Valid |
| GB/T 19701.1-2016 | 110 | Add to Cart | Auto, 9 seconds. | Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 1: Powder form | Valid |
| GB/T 19701.1-2005 | 239 | Add to Cart | 2 days | Implants for surgery -- Ultra-high molecular weight polyethylene -- Part 1: Powder form | Obsolete |
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GB/T 19701.1-2024: Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT19701.1-2024
GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.40 CCS C 35 Replacing GB/T 19701.1-2016 Implants for Surgery - Ultra-high-molecular-weight Polyethylene - Part 1.Powder Form (ISO 5834-1.2019, MOD) Issued on: NOVEMBER 28, 2024 Implemented on: DECEMBER 1, 2025 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3 Introduction... 5 1 Scope... 6 2 Normative References... 6 3 Terms and Definitions... 6 4 Classification... 7 5 Manufacturing Requirements... 7 6 Flow Properties... 7 7 Impurity Limits... 7 8 Test Methods... 8 9 Test Report... 9 10 Labelling... 9 Bibliography... 11Foreword
This document was drafted in accordance with the rules provided in GB/T 1.1-2020 Directives for Standardization - Part 1.Rules for the Structure and Drafting of Standardizing Documents. This document is Part 1 of GB/T 19701 Implants for Surgery - Ultra-high-molecular-weight Polyethylene. GB/T 19701 has issued the following parts. ---Part 1.Powder form; ---Part 2.Moulded forms; ---Part 3.Accelerated ageing methods; ---Part 5.Morphology assessment method. This document serves as a replacement for GB/T 19701.1-2016 Implants for Surgery - Ultra- high-molecular-weight Polyethylene - Part 1.Powder Form. In comparison with GB/T 19701.1-2016, apart from structural adjustments and editorial modifications, the main technical changes are as follows. ---The reference Standard of the test method for stress at definite elongation is modified (see 8.1; 8.1 of Version 2016); ---The reference Standard of the test method for viscosity is modified (see 8.2; 8.2 of Version 2016); ---The reference Standard of the test method for ash content is modified (see 8.3; 8.3 of Version 2016); ---The reference Standard of the test report is added [see Chapter 9 a)]. This document modifies and adopts ISO 5834-1.2019 Implants for Surgery - Ultra-high- molecular-weight Polyethylene - Part 1.Powder Form. The technical differences between this document and ISO 5834-1.2019, and the causes for the differences are as follows. ---The normative reference GB/T 21461.1 is used to replace ISO 11542-1 (see Chapter 3), so as to adapt to the technical conditions of China and enhance the operability; ---The normative reference GB/T 21461.2 is used to replace ISO 11542-2 (see Chapter 3, 8.1), so as to adapt to the technical conditions of China and enhance the operability; ---The normative reference GB/T 1632.3 is used to replace ISO 1628-3 (see 8.2), so as to adapt to the technical conditions of China and enhance the operability; Implants for Surgery - Ultra-high-molecular-weight Polyethylene - Part 1.Powder Form1 Scope
This document specifies the requirements for ultra-high-molecular-weight polyethylene (PE- UHMW) powders for surgical implants and describes the corresponding test methods. This document does not apply to products made from powders.2 Normative References
The contents of the following documents constitute indispensable clauses of this document through the normative references in the text. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 1632.3 Plastics - Determination of the Viscosity of Polymers in Dilute Solution Using Capillary Viscometer - Part 3.Polyethylenes and Polypropylenes (GB/T 1632.3-2010, ISO 1628-3.2001, MOD) GB/T 9345.1 Plastics - Determination of Ash - Part 1.General Methods (GB/T 9345.1-2008, ISO 3451-1.1997, IDT) GB/T 21461.1 Plastics - Ultra-high-molecular-weight Polyethylene (PE-UHMW) Moulding and Extrusion Materials - Part 1.Designation System and Basis for Specifications (GB/T 21461.1-2023, ISO 21304-1.2019, MOD) GB/T 21461.2 Plastics - Ultra-high-molecular-weight Polyethylene (PE-UHMW) Moulding and Extrusion Materials - Part 2.Preparation of Test Specimens and Determination of Properties (GB/T 21461.2-2023, ISO 21304-2.2021, MOD) DIN 53474 Testing of Plastics, Rubber and Elastomers - Determination of the Chlorine Content (Wickbold-combustion)3 Terms and Definitions
The terms and definitions defined in GB/T 21461.1 and GB/T 21461.2 are applicable to this document. The URLs of the terminology databases for standardization maintained by ISO and IEC are as ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
