Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
GB/T 19701 consists of the following parts, under the general title Implants for Surgery — Ultra-high-molecular-weight Polyethylene:
— Part 1: Powder Form;
— Part 2: Moulded Forms;
— Part 3: Accelerated Ageing Methods;
— Part 4: Oxidation Index Measurement Method;
— Part 5: Morphology Assessment Method.
This part is Part 1 of GB/T 19701.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 19701.1-2005 Implants for Surgery — Ultra-high-molecular-weight Polyethylene — Part 1: Powder Form in whole, and the following technical deviations have been made with respect to the GB/T 19701.1-2005:
— the English abbreviation of ultra-high-molecular-weight polyethylene is modified from PE-UHMW to UHMWPE (see Clauses 1 and 8; Clauses 1 and 8 of Edition 2005);
— the ash, calcium, chlorine and aluminum contents of Types 1 and 2 materials in Table 2 are modified (see Table 2; Table 2 of Edition 2005);
— the particles of contaminant in 7.2 is modified (see 7.2; 7.2 of Edition 2005);
This part is identical with International Standard ISO 5834-1:2005 Implants for Surgery — Ultra-high-molecular-weight Polyethylene — Part 1: Powder Form.
The Chinese documents identical to the normative international documents given 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: Polyethylenes 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) Moulding and Extrusion Materials — Part 1: Designation System and Basis for Specifications (ISO 11542-1:2001, IDT)
— GB/T 21461.2-2008 Plastics — Ultra-high-molecular-weight Polyethylene (PE-UHMW) Moulding and Extrusion Materials — Part 2: Preparation of Test Specimens and Determination of Properties (ISO 11542-2:1998, MOD)
This part was proposed by China State Food and Drug Administration.
This part is under the jurisdiction of National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China (SAC/TC 110).
Drafting organization of this part: China State Food and Drug Administration - Tianjin Quality Supervision and Inspection Center for Medical Devices.
This part was issued in March 2005 as first edition, and this is the first revised edition.
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 moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
This part is not applicable to finished products.
2 Normative References
The following referenced documents are indispensable for the application 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.
ISO 1628-3 Plastics — Determination of the Viscosity of Polymers in Dilute Solution Using Capillary Viscometer — Part 3: Polyethylenes 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.
4 Classification
The powdered material shall be classified as Type 1, Type 2 or Type 3 as defined by the flow properties given in Clause 6 and the ash/trace element contents given in 7.1.
5 Manufacturing Requirements
The powdered material shall consist of a homopolymer prepared by the polymerization of ethylene.
The powdered material supplied for each order shall be identified by lot numbers.
Note: “Lot” refers to the material for which testing has been carried out and for which discrete records are kept.
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
Property Units Type 1 Types 2 and 3 Test method according to subclause
Elongational stress MPa 0.2 0.42 8.1
Viscosity number mL/g 2000 3200 8.2
Note: Compliance with either of the above test requirements indicates satisfactory polymer molecular mass.
7 Limits of Contamination
7.1 Ash and trace elements
When measured using the appropriate test method, as defined in Table 2, the amounts of ash, Ti, Ca, Cl and Al shall not exceed the relevant value given in Table 2 for each type of material.
Table 2 Maximum ash and trace element content
Element Maximum quantity permitted (mg/kg) Test method according to subclause
Type 1 Type 2 Type 3a
Ash 125 125 300 8.3
Ti 40 40 150 8.4
Ca 5 5 50 8.4
Cl 30 30 90 8.4
Al 20 20 100 8.4
a Type 3 polymer is no longer manufactured. Type 3 material is retained in this part until the next revision.
7.2 Particulate matter
When measured using the test method given in 8.5, there shall be no more than three particles of contaminant in Type 1 or Type 2 materials and not more than 25 particles of contaminant in Type 3 materials (see Footnote to Table 2), per (300 ± 20) g tested.
Foreword II 1 Scope 2 Normative References 3 Terms and Definitions 4 Classification 5 Manufacturing Requirements 6 Flow Properties 7 Limits of Contamination 8 Test Methods 9 Test Certificate 10 Labelling
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
GB/T 19701 consists of the following parts, under the general title Implants for Surgery — Ultra-high-molecular-weight Polyethylene:
— Part 1: Powder Form;
— Part 2: Moulded Forms;
— Part 3: Accelerated Ageing Methods;
— Part 4: Oxidation Index Measurement Method;
— Part 5: Morphology Assessment Method.
This part is Part 1 of GB/T 19701.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 19701.1-2005 Implants for Surgery — Ultra-high-molecular-weight Polyethylene — Part 1: Powder Form in whole, and the following technical deviations have been made with respect to the GB/T 19701.1-2005:
— the English abbreviation of ultra-high-molecular-weight polyethylene is modified from PE-UHMW to UHMWPE (see Clauses 1 and 8; Clauses 1 and 8 of Edition 2005);
— the ash, calcium, chlorine and aluminum contents of Types 1 and 2 materials in Table 2 are modified (see Table 2; Table 2 of Edition 2005);
— the particles of contaminant in 7.2 is modified (see 7.2; 7.2 of Edition 2005);
This part is identical with International Standard ISO 5834-1:2005 Implants for Surgery — Ultra-high-molecular-weight Polyethylene — Part 1: Powder Form.
The Chinese documents identical to the normative international documents given 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: Polyethylenes 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) Moulding and Extrusion Materials — Part 1: Designation System and Basis for Specifications (ISO 11542-1:2001, IDT)
— GB/T 21461.2-2008 Plastics — Ultra-high-molecular-weight Polyethylene (PE-UHMW) Moulding and Extrusion Materials — Part 2: Preparation of Test Specimens and Determination of Properties (ISO 11542-2:1998, MOD)
This part was proposed by China State Food and Drug Administration.
This part is under the jurisdiction of National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China (SAC/TC 110).
Drafting organization of this part: China State Food and Drug Administration - Tianjin Quality Supervision and Inspection Center for Medical Devices.
This part was issued in March 2005 as first edition, and this is the first revised edition.
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 moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
This part is not applicable to finished products.
2 Normative References
The following referenced documents are indispensable for the application 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.
ISO 1628-3 Plastics — Determination of the Viscosity of Polymers in Dilute Solution Using Capillary Viscometer — Part 3: Polyethylenes 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.
4 Classification
The powdered material shall be classified as Type 1, Type 2 or Type 3 as defined by the flow properties given in Clause 6 and the ash/trace element contents given in 7.1.
5 Manufacturing Requirements
The powdered material shall consist of a homopolymer prepared by the polymerization of ethylene.
The powdered material supplied for each order shall be identified by lot numbers.
Note: “Lot” refers to the material for which testing has been carried out and for which discrete records are kept.
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
Property Units Type 1 Types 2 and 3 Test method according to subclause
Elongational stress MPa 0.2 0.42 8.1
Viscosity number mL/g 2000 3200 8.2
Note: Compliance with either of the above test requirements indicates satisfactory polymer molecular mass.
7 Limits of Contamination
7.1 Ash and trace elements
When measured using the appropriate test method, as defined in Table 2, the amounts of ash, Ti, Ca, Cl and Al shall not exceed the relevant value given in Table 2 for each type of material.
Table 2 Maximum ash and trace element content
Element Maximum quantity permitted (mg/kg) Test method according to subclause
Type 1 Type 2 Type 3a
Ash 125 125 300 8.3
Ti 40 40 150 8.4
Ca 5 5 50 8.4
Cl 30 30 90 8.4
Al 20 20 100 8.4
a Type 3 polymer is no longer manufactured. Type 3 material is retained in this part until the next revision.
7.2 Particulate matter
When measured using the test method given in 8.5, there shall be no more than three particles of contaminant in Type 1 or Type 2 materials and not more than 25 particles of contaminant in Type 3 materials (see Footnote to Table 2), per (300 ± 20) g tested.
Contents of GB/T 19701.1-2016
Foreword II
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification
5 Manufacturing Requirements
6 Flow Properties
7 Limits of Contamination
8 Test Methods
9 Test Certificate
10 Labelling
