GB/T 19701.1-2016 (GB/T19701.1-2016, GBT 19701.1-2016, GBT19701.1-2016) & related versions
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Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 1: Powder form
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GB/T 19701.1-2016
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
GB/T 19701.1-2016 / ISO 5834-1:2005
Replacing GB/T 19701.1-2005
Implants for Surgery – Ultra-High-Molecular-Weight
Polyethylene – Part 1: Powder Form
(ISO 5834-1:2005, 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 Terms and Definitions ... 5
4 Classification ... 6
5 Manufacturing Requirements ... 6
6 Flow Properties ... 6
7 Impurity Limits ... 6
8 Test Methods ... 7
9 Inspection Certificate ... 8
10 Labels ... 8
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 1 of GB/T 19701.
This Part was drafted as per the rules stipulated in GB/T 1.1-2009.
This Part replaced GB/T 19701.1-2005 Implants for Surgery – Ultra-High-Molecular-Weight
Polyethylene – Part 1: Powder Form. Compared with GB/T 19701.1-2005, the major technical
changes of this Part are as follows:
--- Modify the English abbreviation PE-UHMW for ultra-high molecular weight
polyethylene to UHMWPE (see Clause 1, Clause 8 of this Edition; Clause 1, Clause 8 of
the 2005 Edition);
--- Modify the ash content, calcium content, chlorine content and aluminum content of Type
1 and Type 2 materials in Table 2 (see Table 2 of this Edition; Table 2 of 2005 Edition);
--- Modify the number of impurity particles in 7.2 (see 7.2 of this Edition; 7.2 of 2005
Edition).
This Part used interpretation method to equivalently adopt ISO 5834-1:2005 Implants for
Surgery – Ultra-High-Molecular-Weight Polyethylene – Part 1: Powder Form.
The Chinese documents that have consistent correspondence with the international documents
normatively cited in this Part are as follows:
--- GB/T 1632.3-2010 Plastics - Determination of the viscosity of polymers in dilute solution
using capillary viscometer - Part 3: Polyethylene and polypropylenes (ISO 1628-3:2001,
MOD)
--- GB/T 9345.1-2008 Plastics - Determination of ash - Part 1: General methods (ISO 3451-
1:1997, IDT)
--- GB/T 21461.1-2008 Plastics - Ultra-high-molecular-weight polyethylene (PE-UHMW)
Implants for Surgery – Ultra-High-Molecular-Weight
Polyethylene – Part 1: Powder Form
1 Scope
This Part of GB/T 19701 specifies the requirements and corresponding test methods for ultra-
high molecular weight polyethylene (UHMWPE) powder for surgical implants.
This Part does not apply to finished products.
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 1628-3 Plastics – Determination of the viscosity of polymers in dilute solution using
capillary viscometers – Part 3: Polyethylene and polypropylenes
ISO 3451-1 Plastics – Determination of ash – Part 1: General Methods
ISO 11542-1 Plastics – Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding
and extrusion materials – Part 1: Designation system and basis for specifications
ISO 11542-2 Plastics – Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding
and extrusion materials – Part 2: Preparation of test specimens and determination of
properties
DIN 53474 Testing of plastics, rubber and elastomers – Determination of the chlorine
content (Wickbold-combustion)
3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in ISO 11542-1 and ISO
11542-2 apply.
7.2 Particulate matter
When measured according to the test method given in 8.5, the number of impurity particles per
(300±20) g of Type-1 or Type-2 material shall not exceed 3; and the number of impurity
particles per (300±20) g of Type 3 material (see Footnote of Table 2) shall not exceed 25.
8 Test Methods
Warning: Ultra-high molecular weight polyethylene (UHMWPE) powder, semi-finished
products and finished products for surgical implants do not contain light stabilizers, so be
careful to avoid ultraviolet radiation.
8.1 Tensile stress
Tensile stress shall be measured according to the method specified in ISO 11542-2.
8.2 Viscosity number
The viscosity number shall be measured in accordance with the method specified in ISO 1628-
3 at 135°C using a decalin solution with a mass fraction of 0.02%.
8.3 Ash content
The ash content shall be measured according to the method specified in ISO 3451-1; and two
samples shall be taken for parallel testing at (700±50)℃. The average of the measurement
results of the two samples shall not exceed the values given in Table 2.
8.4 Impurity elements
The content of impurity elements shall be determined according to the method given in Table
3.
......
| Standard ID | GB/T 19701.1-2016 (GB/T19701.1-2016) | | Description (Translated English) | Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 1: Powder form | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 6,690 | | Date of Issue | 2016-12-13 | | Date of Implementation | 2018-07-01 | | Older Standard (superseded by this standard) | GB/T 19701.1-2005 | | 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 Announcement No.105 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 19701.1-2005 (GB/T19701.1-2005) | | Description (Translated English) | Implants for surgery. Ultra-hith molecular weight polyethylene. Part 1: Powder form | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 6,660 | | Date of Issue | 2005-03-23 | | Date of Implementation | 2005-12-01 | | Adopted Standard | ISO 5834-1-1998; 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: the ultra-high molecular weight polyethylene (PE-UHWM) material powder requirements and appropriate Test methods. Powder molding material for the manufacture of surgical implants products. |
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