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Position: Chinese Standard in English/GB/T 19701.1-2016
GB/T 19701.1-2016   Implants for surgery--Ultra-high-molecular-weight polyethylene--Part 1: Powder form (English Version)
Standard No.: GB/T 19701.1-2016 Status:to be superseded remind me the status change

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Implemented on:2018-7-1 Delivery: via email in 1 business day
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Standard No.: GB/T 19701.1-2016
English Name: Implants for surgery--Ultra-high-molecular-weight polyethylene--Part 1: Powder form
Chinese Name: 外科植入物 超高分子量聚乙烯 第1部分:粉料
Chinese Classification: C35    Orthopedic devices
Professional Classification: GB    National Standard
ICS Classification: 11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by: AQSIQ;SAC
Issued on: 2016-12-13
Implemented on: 2018-7-1
Status: to be superseded
Superseded by:GB/T 19701.1-2024 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form
Superseded on:2025-12-1
Superseding:GB/T 19701.1-2005 Implants for surgery - Ultra-high molecular weight polyethylene part 1:powder form
Language: English
File Format: PDF
Word Count: 3500 words
Price(USD): 100.0
Delivery: via email in 1 business day
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
Referred in GB/T 19701.1-2016:
*QC/T 276-1999 Specifications for heat treatment hardness of automobile parts
*JTG D50-2017 Specifications for Design of Highway Asphalt Pavement
*GB 5009.262-2016 National Food Safety Standard - Determination of Solvent Residual Quantity in Foods
*JB/T 5932.5-2017 Crawler tractor-dozer. Seal track - Part 5: Track bolt
*QB/T 5133-2017 Requirement and test method for antibacterial and eliminating bacterial function for household and similar electrical dish washers
*QB/T 5130-2017 Electrical wet vacuum cleaners
*QB/T 1560-2017 Accessories of bathroom
*SH/T 3038-2017 Code for Electric Power Design in Petrochemical Plants
*QC/T 727-2004 Instrument for automobile and motorcycle
*FZ/T 81006-2017 Jeanswear
*TSG ZF001-2006/XG1-2009 Safety Technical Supervision Regulation for Safety Valves, includes Amendment 1
GB/T 19701.1-2016 is referred in:
*YY 0502-2016 Joint replacement implants―Knee joint prostheses
*YY 0118-2016 Joint replacement implants - Hip joint prostheses
*GB 5009.27-2016 Determination of benzo (a) pyrene in foods
*EJ 878-1994 Safety Design Guidelines for Away-from-reactor Storage Pool Used for Spent Fuel
*GB/T 33761-2017 General principles for green product assessment
*GB/T 32918.5-2017 Information security technology―Public key cryptographic algorithm SM2 based on elliptic curves―Part 5:Parameter definition
*GB/T 31983.31-2017 Narrow band power line communication over low-voltage mains―Part 31:Narrow band orthogonal frequency division multiplexing power line―Communication physical layer specification
Code of China
Standard
GB/T 19701.1-2016  Implants for surgery--Ultra-high-molecular-weight polyethylene--Part 1: Powder form (English Version)
Standard No.GB/T 19701.1-2016
Statusto be superseded
LanguageEnglish
File FormatPDF
Word Count3500 words
Price(USD)100.0
Implemented on2018-7-1
Deliveryvia email in 1 business day
Detail of GB/T 19701.1-2016
Standard No.
GB/T 19701.1-2016
English Name
Implants for surgery--Ultra-high-molecular-weight polyethylene--Part 1: Powder form
Chinese Name
外科植入物 超高分子量聚乙烯 第1部分:粉料
Chinese Classification
C35
Professional Classification
GB
ICS Classification
Issued by
AQSIQ;SAC
Issued on
2016-12-13
Implemented on
2018-7-1
Status
to be superseded
Superseded by
GB/T 19701.1-2024 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form
Superseded on
2025-12-1
Abolished on
Superseding
GB/T 19701.1-2005 Implants for surgery - Ultra-high molecular weight polyethylene part 1:powder form
Language
English
File Format
PDF
Word Count
3500 words
Price(USD)
100.0
Keywords
GB/T 19701.1-2016, GB 19701.1-2016, GBT 19701.1-2016, GB/T19701.1-2016, GB/T 19701.1, GB/T19701.1, GB19701.1-2016, GB 19701.1, GB19701.1, GBT19701.1-2016, GBT 19701.1, GBT19701.1
Introduction of GB/T 19701.1-2016
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
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Keywords:
GB/T 19701.1-2016, GB 19701.1-2016, GBT 19701.1-2016, GB/T19701.1-2016, GB/T 19701.1, GB/T19701.1, GB19701.1-2016, GB 19701.1, GB19701.1, GBT19701.1-2016, GBT 19701.1, GBT19701.1