标准编号 Standard/Code | 标准名称 Standard Title |
ASTM D3578 | Standard Specification for Rubber Examination Gloves |
This specification covers certain requirements for natural rubber gloves intended for use in medical examinations and diagnostic and therapeutic procedures as well as in handling contaminated medical material. Material under this specification consists of Type I and Type II gloves, which shall be manufactured from any natural rubber compound, with the inside and outside surfaces of the gloves free of talc and with dimensions and physical properties that shall conform to the requirements specified. Tests for sterility, freedom from holes, physical dimensions, tensile strength, ultimate elongation, stress at elongation, powder-free residue, powder amount, protein content, and antigenic protein content shall be performed to assess the conformance of the rubber gloves with the requirements specified.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
Significance and Use
5.1 The specification is intended as a reference to the performance and safety of natural rubber examination gloves. The safe and proper use of natural rubber examination gloves is beyond the scope of this specification.
1. Scope
1.1 This specification covers certain requirements for natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material.
1.2 This specification provides for natural rubber gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile natural rubber gloves and packaged or bulk nonsterile natural rubber gloves.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Test Name 测试名称: ASTM D3578 Standard Specification for Rubber Examination Gloves 乳胶检查手套
Test Requirements 测试要求:
1) Freedom from holes
2) Dimensions
3) Physical properties (before and after accelerated ageing at 70±2°C for 166±2h)
4) Powder free residue
5) Protein content
Sample Size 样品数量 / 送样规格: 400pcs for per LOT (35,001-150,000 pcs)
Lead Time / TAT (Turn Around Time) 测试周期: 常规服务 Regular service 3-4 weeks
Report Summary 报告摘要:
Standard Interpretation 标准解读:
标准对乳胶手套规定的技术指标分强制性要求和非强制性要求两方面。在非强制性要求方面,根据物理性能的不同,将乳胶手套分为两类。对一类手套的物理性能要求:老化前的拉伸强度应不小于18MPa,扯断伸长率不小于700%;当一类手套伸长率为500%时,拉伸强度应不大于5.5MPa;老化后拉伸强度应不小于14MPa,扯断伸长率应不小于500%。对二类手套的物理性能要求;老化前后的拉伸强度都不小于14MPa;老化前的扯断伸长率不小于650%,老化后扯断伸长率不小于500%;另外要求老化前在伸长率为500%时的拉伸强度不大于2.8MPa。在强制性要求方面规定:蛋白质含量不得超过100ug/dm2;残留粉含量不得超过2mg/dm2;平均粉含量不得超过10mg/dm2。对抗原性蛋白质含量的指标,要求不得超过10ug/dm2。美国FDA(食品与药物管理局)在对进口和市场销售的乳胶手套检查时,都以 ASTM D3578标准为检验依据。