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YY/T 1431-2016: Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1431-2016 | English | 159 |
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Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns
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YY/T 1431-2016
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Basic data | Standard ID | YY/T 1431-2016 (YY/T1431-2016) | | Description (Translated English) | Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 8,898 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | GB/T 1033.1; GB/T 1632.3; GB/T 3916; GB/T 4743; GB/T 16886.10; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.17; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.9; GB/T 16886.2; GB/T 16886.19; GB/T 16886.1; GB/T 16886.18 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to ultra-high molecular weight polyethylene (UHMWPE) yarns used as raw materials for medical device parts (eg for stitching or ligament fixation). The purpose of this standard is to describe the properties required for ultra high molecular weight polyethylene yarns as raw materials for medical devices and the test procedures to be followed. This standard is not intended to address the tests required for the components of medical devices or medical devices processed from the raw materials specified in this standard. The basic principles of this standard are given in Appendix A. This standard adopts the international unit system. This standard does not include other units of measurement. The following warnings apply only to the test method section of Chapter 6 of this standard: This standard does not attempt to address all the security issues involved, even those related to their use. Establish appropriate safety and operational specifications, as well as before the application | YY/T 1431-2016: Implants for surgery. Medical-grade ultra-high molecular weight polyethylene yarns
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Implants for surgery .Medical-grade ultra-high molecular weight polyethylene yarns
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical Implant Medical Grade Ultra High Molecular Weight
Polyethylene yarn
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is nationalized by the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110).
The drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, the State Food and Drug Administration
Bureau of Medical Device Technical Review Center.
The main drafters of this standard. Ma Chunbao, Duan Qingjiao, Zhang Chen, Meng Tao, Dong Wenxing, Guo Xiaolei.
Surgical Implant Medical Grade Ultra High Molecular Weight
Polyethylene yarn
1 Scope
This standard applies to medical device parts as raw materials (such as stitching or ligament fixation) for the use of ultra-high molecular weight polyethylene
(UHMWPE) yarn.
The purpose of this standard is to describe the properties required for ultra high molecular weight polyethylene yarns as raw materials for medical devices and the test procedures to be followed
sequence. This standard is not intended to address the tests required for the manufacture of medical devices or medical devices that are processed from the raw materials specified in this standard. this
The basic principles of the standard are given in Appendix A.
This standard adopts the international unit system. This standard does not include other units of measurement.
The following warnings apply only to the test method section of Chapter 6 of this standard. This standard is not intended to address all safety concerns
To elaborate, even those related to their use of security issues. Establish appropriate safety and operational specifications, and clearly manage before application
The applicability of the restrictions is the responsibility of the user of this standard.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 1033.1 Plastics - Determination of non-foam density - Part 1. Impregnation, liquid pycnometer and titration
GB/T 1632.3 Plastics - Determination of viscosity of polymer dilute solution using capillary viscometers - Part 3. Polyethylene and polypropylene
GB/T 3916 Textiles - Single yarn yarns - Determination of breaking strength and elongation at break (CRE method)
GB/T 4743 Textiles - Rolling yarns - Determination of linear density
GB/T 16886 (all parts) Biological evaluation of medical devices
GB/T 19701.1 Surgical implants - Ultrahigh molecular weight polyethylene - Part 1. Powders
Surgical implants - Ultra - high molecular weight polyethylene - Part 2. Molded plastics GB/T
Pharmacopoeia of the People's Republic of China (2)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
UHMWPE filament
The molecularly oriented highly crystalline fibers are spun from UHMWPE polymer powders.
3.2
UHMWPE yarn
It is processed by specially operated UHMWPE filaments without packaging and sterilization, such as weaving and knitting.
3.3
Line density
The mass per unit length, expressed in dtex (mass per 10,000 m, in g).
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