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YY/T 0114-2008 English PDF

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YY/T 0114-2008: Polyethylene material for manufacture of infusion, transfusion and injection equipments for medical use

YY/T 0114: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0114-2008English279 Add to Cart 3 days [Need to translate] Polyethylene material for manufacture of infusion, transfusion and injection equipments for medical use   YY/T 0114-2008
YY/T 0114-1993EnglishRFQ ASK 3 days [Need to translate] (Medical infusion, transfusion, syringes polyethylene Compound) Obsolete YY/T 0114-1993

PDF similar to YY/T 0114-2008


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Basic data

Standard ID YY/T 0114-2008 (YY/T0114-2008)
Description (Translated English) Polyethylene material for manufacture of infusion, transfusion and injection equipments for medical use
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard G32;C31
Classification of International Standard 11.040.20
Word Count Estimation 8,817
Date of Issue 2008-10-17
Date of Implementation 2010-01-01
Older Standard (superseded by this standard) YY 0114-1993
Quoted Standard GB/T 1033-1986; GB/T 1040.1-2006; GB/T 1040.2-2006; GB/T 1250-1989; GB/T 1843-1996; GB/T 1845.2-2006; GB/T 2547; GB/T 2918-1998; GB/T 3682-2000; GB/T 9341-2000; GB/T 9352-1988; GB/T 14233.1-1998; GB/T 14233.2-2005; GB/T 16886.1; GB/T 17037.1-1997; YY 0466; SH/T 1541-2006
Regulation (derived from) SFDA [2008] No. 605
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies Infusion, transfusion, injection equipment with polyethylene special material requirements, test methods, inspection rules, marking, packaging, transport and storage. This standard applies to medical infusion, transfusion, injection equipment Polyethylene Compound (hereinafter referred to as "Medical Polyethylene Compound").

YY/T 0114-2008: Polyethylene material for manufacture of infusion, transfusion and injection equipments for medical use


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Polyethylene material for manufacture of infusion, transfusion and injection equipments for medical use ICS 11.040.20 C31 People's Republic of China pharmaceutical industry standards Replacing YY 0114-1993 Infusion, transfusion, injection equipment Polyethylene Compound Posted 2008-10-17 2010-01-01 implementation State Food and Drug Administration issued

Foreword

This standard replaces YY 0114-1993 "medical infusion, transfusion, injection equipment Polyethylene Compound." This standard YY 0114-1993 compared to major differences are. --- Adjusted by the mandatory standards recommended standards; --- Added "particle appearance" requirement; --- Modify the "melt flow rate" requirements; --- Modify the "Izod notched impact strength" units and requirements; --- Added "UV absorbance" requirement; --- Modify the "heavy metal content" requirement. The standard medical infusion by the National Standardization Technical Committee appliances. This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This standard drafting unit. China Petrochemical Qilu Company Research Institute Co., Ltd., Shandong Province Medical Devices Product Quality Inspection Center. The main drafters of this standard. Liushao Cheng, Zhang Guangming, Chengzhi Ling, YUAN Dongxing, Li Jing, Liu Lili. This standard was first released in April 1993. Infusion, transfusion, injection equipment Polyethylene Compound

1 Scope

This standard specifies the medical infusion, transfusion, injection equipment polyethylene special material requirements, test methods, inspection rules, marking, packaging, Transport and storage. This standard applies to medical infusion, transfusion, injection equipment of special polyethylene (hereinafter referred to as "medical Polyethylene Compound").

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 1033-1986 plastic density and relative density test method (eqv ISO /DIS1183. 1984) GB/1040.1-2006 Plastics Determination of tensile properties T Part 1. General (ISO 527-1.1993, IDT) 1040.2-2006 Plastics Determination of tensile properties GB/T Part 2. Test plastics molding and extrusion conditions (ISO 527-2.1993, IDT) Representation GB/T 1250-1989 and method of determining the limit values GB/T 1843-1996 plastic Izod impact test method (eqv ISO 180.1993) GB/T 1845.2-2006 plastic polyethylene (PE) molding and extrusion materials - Part 2. Preparation of test specimens and determination GB/T 2547 plastic resin sampling method GB/T 2918-1998 standard plastic sample conditioning and environmental tests (idt ISO 291.1997) GB/T 3682-2000 quality thermoplastic melt flow rate and melt volume flow rate measurement (idt ISO 1133.1997) GB/T 9341-2000 Plastic bending performance test methods (idt ISO 178.1993) GB/T 9352-1988 thermoplastics Sample Preparation (. 1986 neq ISO 293) compression molding GB/T 14233.1-1998 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing (GB/T 16886.1-2001, idt ISO 10993-1.1997) GB/T 17037.1-1997 Preparation of injection molded thermoplastic material specimens - Part 1. General principles and multipurpose specimens and long Article prepared sample YY 0466 medical equipment used with medical device labels, signs and symbols provide information (YY 0466-2003, ISO 15223.2000, IDT) SH/T 1541-2006 Test method for thermoplastic granules Appearance

3 Requirements

3.1 Grain appearance Medical Compound polyethylene natural color particles. Physical and mechanical properties of polyethylene 3.2 Compound of medical and chemical properties Physical and mechanical properties of polyethylene specialized material for medical and chemical properties are shown in Table 1.

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