GB/T 19701.2-2024_English: PDF (GB/T19701.2-2024)
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
GB/T 19701.2-2024 | English | 199 |
Add to Cart
|
3 days [Need to translate]
|
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
| Valid |
GB/T 19701.2-2024
|
GB/T 19701.2-2016 | English | 190 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 2: Moulded forms
| Valid |
GB/T 19701.2-2016
|
GB/T 19701.2-2005 | English | 90 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Implants for surgery Ultra-high molecular weight polyethylene -- Part 2: Moulded forms
| Obsolete |
GB/T 19701.2-2005
|
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| Word Count Estimation | 10,127 | Date of Issue | 2024-11-28 | Date of Implementation | 2025-12-01 | Older Standard (superseded by this standard) | GB/T 19701.2-2016 | Drafting Organization | Tianjin Medical Device Quality Supervision and Inspection Center, National Medical Products Administration Medical Device Technical Review and Inspection Greater Bay Area Center, Beijing Antong Yitai Medical Technology Co., Ltd., Beijing Mengtaiyin Medical Equipment Co., Ltd. | Administrative Organization | National Surgical Implants and Orthopedic Devices Standardization Technical Committee (SAC/TC 110) | Proposing organization | National Drug Administration | Issuing agency(ies) | State Administration of Market Supervision and Administration, National Administration of Standardization | Standard ID | GB/T 19701.2-2016 (GB/T19701.2-2016) | 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| Word Count Estimation | 10,126 | Date of Issue | 2016-12-13 | Date of Implementation | 2018-07-01 | Older Standard (superseded by this standard) | GB/T 19701.2-2005 | Drafting Organization | State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center | Administrative Organization | National Standard Committee on Surgical Implants and Orthopedic Instruments (SAC/TC 110) | Regulation (derived from) | National Standard Notice No.106 of 2016 | Proposing organization | State Administration of Food and Drug Administration | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee | Standard ID | GB/T 19701.2-2005 (GB/T19701.2-2005) | 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 | 6,662 | Date of Issue | 2005-03-23 | Date of Implementation | 2005-12-01 | Adopted Standard | ISO 5834-2-1998; IDT | Drafting Organization | State Food and Drug Administration, Tianjin Medical Device Quality Supervision and Inspection Center | Administrative Organization | National Surgical implants and orthopedic instruments Standardization Technical Committee | Regulation (derived from) | Announcement of Newly Approved National Standards No. 6, 2005 (No. 80 overall) | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee | Summary | This standard specifies: molded plastic surgical implants with ultra-high molecular weight polyethylene (PE-UHMW) requirements and appropriate Test methods. This standard does not apply to the direct molding or final products. |
GB/T 19701.2-2024.Ultra-high molecular weight polyethylene for surgical implants Part 2.Moulding compounds
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 Range 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
Preface
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.
......
GB/T 19701.2-2016
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
GB/T 19701.2-2016 / ISO 5834-2:2011
Replacing GB/T 19701.2-2005
Implants for Surgery – Ultra-High-Molecular-Weight
Polyethylene – Part 2: Moulded Forms
(ISO 5834-2:2011, IDT)
ISSUED ON: DECEMBER 13, 2016
IMPLEMENTED ON: JULY 1, 2018
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Classification ... 5
4 Materials ... 6
5 Manufacturing Requirements ... 6
6 Requirements ... 6
7 Test Methods ... 7
8 Marking ... 8
9 Inspection Certificate ... 9
10 Labels ... 9
Bibliography ... 10
Foreword
GB/T 19701 Implants for Surgery – Ultra-High-Molecular-Weight Polyethylene consists of the
following five parts:
--- Part 1: Powder;
--- Part 2: Molded Forms;
--- Part 3: Accelerated Aging Methods;
--- Part 4: Oxidation Index Test Methods;
--- Part 5: Morphological Evaluation Methods.
This Part is Part 2 of GB/T 19701.
This Part was drafted as per the rules stipulated in GB/T 1.1-2009.
This Part replaced GB/T 19701.2-2005 Implants for surgery Ultra-high molecular weight
polyethylene - Part 2: Moulded forms. Compared with GB/T 19701.2-2005, the major technical
changes of this Part are as follows:
--- Change the English abbreviation PE-UHMW of ultra-high molecular weight
polyethylene into UHMWPE (see Clauses 1 and 4 of this Edition; Clauses 1 and 5 of the
2005 Edition);
--- Delete the inapplicable product range in Clause 1;
--- Modify the requirements for double-notch impact strength (socle beam) of Type-I
molding compounds in Table 1 (see Table 1 of this Edition; Table 1 of the 2005 Edition);
--- Modify the naming of various tensile property parameters in Table 1, 7.4, and 7.5 (see
Table 1, 7.4, and 7.5 of this Edition; Table 1, 8.4, and 8.5 of the 2005 Edition);
--- Delete NOTE 1 in Table 1, it is not allowed to add liquid and powder release agents
during the molding process;
--- Modify the NOTE in Table 1 (see Table 1 of this Edition; NOTE 2 in Table 1 of the 2005
Edition);
--- Modify the sampling area of 7.8 particulate matter (see 7.8 of this Edition; 8.8 in the
2005 Edition);
--- Modify f) in Clause 9;
--- Modify Clause 10.
Implants for Surgery – Ultra-High-Molecular-Weight
Polyethylene – Part 2: Moulded Forms
1 Scope
This Part of GB/T 19701 specifies the requirements and corresponding test methods for ultra-
high molecular weight polyethylene (UHMWPE) molding compounds (such as plates, rods)
for surgical implants.
This Part does not apply to directly molded (near final form) products, irradiated products or
final products, nor to products made from polyethylene containing additives or blends of
different types of polyethylene.
2 Normative References
The following documents are essential to the application of this Document. For the dated
documents, only the versions with the dates indicated are applicable to this Document; for the
undated documents, only the latest version (including all the amendments) is applicable to this
Document.
ISO 527-1 Plastics – Determination of tensile properties – Part 1: General Principles
ISO 1183-1 Plastic – Methods for determining the density of no-cellular plastics – Part 1:
Immersion method, Liquid pycnometer method and titration method
ISO 3451-1:2008 Plastics – Determination of ash – Part 1: General methods
ISO 5834-1 Implants for surgery – Ultra-high-molecular weight polyethylene – Part 1:
Powder form
ISO 11542-2:1992 Plastics – Ultra-high-molecular-weight polyethylene (PE-UHMW)
moulding and extrusion materials – Part 2: Preparation of test specimens and determination
of properties
3 Classification
Materials for Type-1, Type-2, and Type-3 powder molding defined by ISO 5834-1 are
accordingly divided into Type-1, Type-2, and Type-3 molding compounds.
4 Materials
The molding compounds shall be molded from UHMWPE powder that meets the requirements
of ISO 5834-1.
5 Manufacturing Requirements
The molding compound supplied with each order shall be marked with the batch number.
NOTE: "Batch" refers to the material unit that has been tested and has independent test records.
The molding compound should be stress-relieved and annealed in accordance with the
agreement between the supplier and the purchaser.
During the molding process, in order to avoid contamination, additive migration and molding
defects, liquid or powdered release agents (such as those based on silicon or talc) shall not be
used.
6 Requirements
6.1 Physical properties
When tested according to the test methods in Table 1, the physical properties of the molding
compound shall comply with the corresponding given values for each type of material in Table
1.
Since subsequent manufacturing processes may affect the comparability of test results, the
physical properties of cured and annealed materials shall be tested before further processing.
6.2 Particulate matter
When inspected with normal or corrected vision without magnification, the number of visible
particles on the surface of the sample shall not exceed 10 when prepared in accordance with
7.8.
The ash shall be measured according to Method-A of ISO 3451-1:2008; take two portions of
specimens to carry out parallel test under the condition of (700±50) °C. The average value of
the test results of 2 specimen shall be no lower than the value given in Table 1.
7.4 Tensile yield stress
The tensile yield stress σy shall be carried out according to the tensile test method stipulated in
ISO 527-1; use the material tester to measure the stress; the test speed is (100±10) mm/min.
Measure at least 5 specimens with thickness of (1.5±0.5) mm. The average value of the test
results of 5 specimens shall be no lower than the value given in Table 1.
7.5 Tensile fracture stress
The tensile fracture stress σR shall be measured under the test conditions specified in 7.4. The
average value of the test results of 5 specimens shall be no lower than the value given in Table
1.
7.6 Elongation at break
The elongation at break εR shall be measured under the test conditions specified in 7.4. The
average value of the test results of 5 specimens shall be no lower than the value given in Table
1.
7.7 Notch impact strength
The double-notch impact strength αCN shall be measured according to the impact test method
specified in Annex B (simple beam) of ISO 11542-2:1998 or ASTM F 648 (socle beam).
In case of the doubts or objections, the test method specified in ISO 11542-2 shall be regarded
as the arbitration inspection method.
7.8 Sampling area of the particulate matter
(500×103) mm2 shall be selected from the machining surface of the molding compound as the
sample surface. The inspection surface shall include the transverse and longitudinal sampling;
and profile can be taken repeatedly from the thickness direction of the molding compound.
8 Marking
The delivered products shall be marked at least batch number. The marking can also be serial
number of reference batch number; such serial number can be used repeatedly within a certain
length.
......
GB/T 19701.2-2005
GB
NATIONAL STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
GB/T 19701.2-2005 / ISO 5834-2.1998
Implants for surgery Ultra-high molecular weight
polyethylene - Part 2. Moulded forms
(ISO 5834-2.1998, IDT)
ISSUED ON. MARCH 23, 2005
IMPLEMENTED ON. DECEMBER 1, 2005
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Definitions ... 5
4 Classification ... 5
5 Material ... 5
6 Manufacturing requirements ... 5
7 Requirements ... 5
8 Test methods ... 6
9 Identification marking ... 7
10 Test certificate ... 7
11 Labelling ... 8
Foreword
This Part identically adopts the international standard ISO 5834-2.1998
Implants for surgery - Ultra-high molecular weight polyethylene - Part 2.
Moulded forms.
GB/T 19701 Implants for surgery Ultra-high molecular weight polyethylene
consists of two parts.
- Part 1. Powder form
- Part 2. Moulded forms
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on
Surgical implants and Orthopedic Instruments of Standardization
Administration of China (CSBTS/TC 110).
Main drafting organizations of this Part. Tianjin Medical Device Quality
Supervision and Inspection Center of China Food and Drug Administration.
Main drafters of this Part. Qi Baofen, Song Duo, Wang Zuoyan, Zhang Wenhui.
Implants for surgery Ultra-high molecular weight
polyethylene - Part 2. Moulded forms
1 Scope
This Part of GB/T 19701 specifies the requirements and corresponding test
methods for moulded forms made from ultra-high molecular weight
polyethylene (PE-UHMW) for use in the manufacture of surgical implants.
It does not apply to direct-moulded or finished products.
2 Normative references
The following standards contain the provisions which, through reference in this
this Part of GB/T 19701, constitute the provisions of this Part. For dated
references, subsequent amendments (excluding corrections) or revisions do
not apply to this Part. However, the parties who enter into agreement based on
this Part are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Part.
GB/T 19701.1-2005 Implants for surgery Ultra-high molecular weight
polyethylene - Part 2. Powder form (ISO 5834-1.1998. IDT)
ISO 527.1976 Plastics - Determination of tensile properties
ISO 1183.1987 Plastics - Methods for determining the density and relative
density of non-cellular plastics
ISO 3451-1.1997 Plastics - Determination of ash - Part 1. General methods
ISO 11542-1.1994 Plastics - Ultra-high-molecular-weight polyethylene
(PE-UHMW) moulding and extrusion materials - Part 1. Designation systems
and basis for specifications
ISO 11542-2.1998 Plastics - Ultra-high-molecular-weight polyethylene
(PE-UHMW) moulding and extrusion materials - Part 2. Preparation of test
specimens and determination of properties
ASTM F 648 Standard specification for ultra-high molecular weight
polyethylene powder and fabricated form for surgical implants
......
|