Powered by Google www.ChineseStandard.net Database: 189760 (20 Apr 2024)

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

GB/T 19701.2-2016_English: PDF (GBT 19701.2-2016, GBT19701.2-2016)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
GB/T 19701.2-2016English190 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

BASIC DATA
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Older Standard (superseded by this standard) GB/T 19701.2-2005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

Standards related to: GB/T 19701.2-2016

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.
...