YY/T 0114-2008Polyethylene material for manufacture of infusion, transfusion and injection equipments for medical use (English PDF)

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.

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