GB/T 19701.1-2024 Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
1 Scope
This document specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in surgical implants.
This document is not applicable to finished products.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 1632.3 Plastics - Determination of the viscosity of polymers in dilute solution using capillary viscometer - Part 3: Polyethylenes and polypropylenes (GB/T 1632.3-2010, ISO 1628-3:2001, MOD)
GB/T 9345.1 Plastics - Determination of ash - Part 1: General methods (GB/T 9345.1-2008, ISO 3451-1:1997, IDT)
GB/T 21461.1 Plastics - Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials - Part 1: Designation system and basis for specifications (GB/T 21461.1-2023, ISO 21304-1:2019, MOD)
GB/T 21461.2 Plastics - Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties (GB/T 21461.2-2023, ISO 21304-2:2021, MOD)
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 GB/T 21461.1 and GB/T 21461.2 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www.iso.org/obp;
— IEC Electropedia: available at http: //www.electropedia.org/.
4 Classification
The material shall be classified as Type 1, Type 2 or Type 3 as defined by the flow properties given in Clause 6, and ash and trace elements given in Clause 7.
5 Manufacturing requirements
The material shall consist of a homopolymer prepared by the polymerization of ethylene.
Batch number shall be marked on the powdered material supplied for each order.
Note: "Batch" means a unit of material that has been tested and has an independent test record.
6 Flow properties
Flow properties shall be determined by measuring either elongation stress or viscosity number. When measured using the appropriate test method, as defined in Table 1, the minimum value of either the elongational stress or the viscosity number shall exceed the relevant value given in Table 1 for each type of material.
Table 1 Flow properties — Minimum values
Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Manufacturing requirements
6 Flow properties
7 Limits of impurities
8 Test methods
9 Test report
10 Labelling
Bibliography
