GB/T 19701.1-2024 PDF English
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GB/T 19701.1-2024: PDF in English (GBT 19701.1-2024) GB/T 19701.1-2024
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... 11
Foreword
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 Form
1 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 PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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