YY/T 0114-2008 (English Version) PDF

Scope: This standard specifies the requirements, test methods, inspection rules, marking, packaging, transportation and storage of polyethylene special materials for medical infusion, blood transfusion and injection equipment. This standard applies to special polyethylene materials for medical infusion, blood transfusion, and injection equipment (hereinafter referred to as "special medical polyethylene materials").

YY/T 0114-2008 Referenced Document

GB/T 1033-1986 Test method for density and relative density of plastics
GB/T 1040.1-2006 Plastics.Determination of tensile properties.Part 1:General principles
GB/T 1040.2-2006 Plastics. Determination of tensile properties. Part 2: Test conditions for moulding and extrusion plastics
GB/T 1250-1989 Rules for expression and judgement of limiting values
GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
GB/T 1843-1996 Plastics--Determination of izod impact strength
GB/T 1845.2-2006 Plastics.Polyethylene (PE) moulding and extrusion materials.Part 2: Preparaation of test specimens and determination of properties
GB/T 2547 Plastic resins-Sampling
GB/T 2918-1998 Plastics--Standard atmospheres for conditioning and testing
GB/T 3682-2000 Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics
GB/T 9341-2000 Plastics--Determination of flexural properties
GB/T 9352-1988 Plastics--Compression moulding test specimens of thermoplastic materials
SH/T 1541-2006 Test method for appearance of thermoplastic granules
YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied

2008 YY/T 0114-2008 Polyethylene material for manufacture of infusion,transfusion and injection equipments for medical use
1993 YY/T 0114-1993 Polyethylene special material for medical infusion, blood transfusion and syringe