1  范围

1     Scope

本标准适用于医用输液、输血、注射器具用聚乙烯专用料（以下简称“医用聚乙烯专用料”）。

This standard specifies the requirements, test methods, inspection rules, marking, packaging, transportation and storage of polypropylene material for manufacture of infusion transfusion and injection equipments for medical use.

This standard is applicable to polypropylene material for manufacture of infusion transfusion and injection equipments for medical use (hereinafter referred to as “polyethylene material for medical use”).

2  规范性引用文件

2     Normative References

下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件，其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件，其最新版本适用于本标准。

The articles in the following documents become the articles of this standard through reference by this standard. For dated references, all the subsequent modification lists (excluding corrigendum) or revised editions are not applicable to this Standard. However, the parties reaching an agreement according to this Standard are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest edition is applicable to this standard.

GB/T 1033—1986 塑料密度和相对密度试验方法（eqv ISO/DIS 1183:1984)

GB/T 1033—1986 Test method for density and relative density of plastics (eqv ISO/DIS 1183:1984)

GB/T 1040.1—2006塑料拉伸性能的测定第1部分：总则（ISO 527-1:1993, IDT)

GB/T 1040.1—2006 Plastics—Determination of tensile properties—Part 1: General principles (ISO 527-1:1993, IDT)

GB/T 1040. 2—2006塑料拉伸性能的测定第2部分:模塑和挤塑塑料的试验条件(ISO 527-2:1993, IDT)

GB/T 1040.2—2006 Plastics - Determination of tensile properties - Part 2: Test conditions for moulding and extrusion plastics (ISO 527-2:1993, IDT)

GB/T 1250—1989极限数值的表示方法和判定方法

GB/T 1250—1989 Rules for expression and judgment of limiting values

GB/T 1843—1996塑料悬臂梁冲击试验方法（eqv ISO 180:1993)

GB/T 1843—1996 Plastics - Determination of izod impact strength (eqv ISO 180: 1993)

GB/T 1845. 2—2006塑料聚乙烯(PE)模塑和挤出材料第2部分:试样制备和性能测定GB/T 2547塑料树脂取样方法

GB/T 1845. 2—2006 Plastics―Polyethylene (PE) moulding and extrusion materials―Part 2: Preparation of test specimens and determination of properties GB/T 2547 Plastic resins - Sampling

GB/T 2918—1998塑料试样状态调节和试验的标准环境（idt ISO 291:1997)

GB/T 2918—1998Plastics-Standard atmospheres for conditioning and testing (idt ISO 291:1997)

GB/T 3682—2000热塑性塑料熔体质量流动速率和熔体体积流动速率的测定(idt ISO 1133:1997)

GB/T 3682—2000 Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics (idt ISO 1133:1997)

GB/T 9341—2000 塑料弯曲性能试验方法（idt ISO 178:1993)

GB/T 9341—2000 Plastics - Determination of flexural properties (idt ISO 178:1993)

GB/T 9352—1988热塑性塑料压塑试样的制备（neq ISO 293:1986)

GB/T 9352—1988 Plastic - Compression moulding of test specimens of thermoplastic materials (neq ISO 293:1986)

GB/T 14233.1—1998医用输液、输血、注射器具检验方法第1部分: 化学分析方法

GB/T 14233.1—1998 Test method for infusion, injection equipments for medical use - Part 1: Chemical analysis methods

GB/T 14233. 2—2005医用输液、输血、注射器具检验方法第2部分:生物学试验方法

GB/T 14233. 2—2005 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods

GB/T 16886. 1 医疗器械生物学评价第1部分：评价与试验（GB/T 16886. 1—2001， idt ISO 10993-1：1997)

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热塑性塑料材料注塑试样的制备第1部分:一般原理及多用途试样和长条试样的制备

GB/T 17037.1—1997 Injection moulding of test specimens of thermoplastic materials - Part 1: General principles and moulding of multipurpose and bar test specimens

YY 0466医疗器械用于医疗器械标签、标记和提供信息的符号(YY 0466—2003，ISO 15223:2000, IDT)

YY 0466 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (YY 0466—2003, ISO 15223—1: 2000, IDT)