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GB/T 19701.2-2016 English PDF (GBT19701.2-2016)

GB/T 19701.2-2016 English PDF (GBT19701.2-2016)

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GB/T 19701.2-2016: Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 2: Moulded forms

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.
GB/T 19701.2-2016
GB
NATIONAL STANDARD OF THE
PEOPLE 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 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 ??y 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 ??R 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 ??R 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 ??CN 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.

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