GB/T 19701.2-2005 English PDF (GBT19701.2-2005)

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GB/T 19701.2-2005: Implants for surgery Ultra-high molecular weight polyethylene -- Part 2: Moulded forms
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