11.120.20 医用材料 标准查询与下载

T/CSBME 001.2-2017 DEHCH 增塑聚氯乙烯（PVC） 第2 部分：双腔支气管插管专用料

本部分规定了双腔支气管插管用环已烷-1,2-二甲酸二异辛酯（DEHCH）增塑聚氯乙烯（PVC） 专用料的材料、技术要求、试验方法、标志、包装、运输和贮存。

DEHCH plasticized polyvinyl chloride ( PVC)-Part 2：Special material for double-lumen bronchail tube

T/CSBME 001.1-2017 DEHCH增塑聚氯乙烯（PVC） 第1部分：气管插管专用料

本部分规定了气管插管用环已烷-1，2-二甲酸二异辛酯（DEHCH）增塑聚氯乙烯（PVC）专用料的材料、技术要求、试验方法、标志、包装、运输和贮存。

DEHCH plasticized polyvinyl chloride ( PVC)-Part 1：Special material for tracheal intubation

DIN 13152:2017 包扎材料.急救袋

This document specifies sterile surgical sheets, especially used in first-aid.

Surgical dressings - Surgical sheets

DB65/T 4021-2017 医用婴儿襁褓

medical baby swaddle

ASTM F1862/F1862M-17 医用面罩对合成血液穿透的标准测试方法（以已知速度的固定体积的水平投影）

1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration. 1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for face exposure and assess the appropriateness of this test method for their specific application. 1.3 This test method primarily addresses the performance of materials or certain material constructions used in medical face masks. This test method does not address the performance of the medical face mask’s design, construction, or interfaces or other factors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop). Procedures for measuring these properties are contained in Test Method F2101 and MIL-M-36954C. 1.4 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask. 1.5 The values stated in SI units or inch-pound units are to be regarded separately as standard. The pressure values stated in each system are not exact equivalents. However, as the corresponding velocities are within 1 % of each other, (see X1.4.2), reporting of the results in either units is permitted. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the 1 This test method is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee F23.40 on Biological. Current edition approved June 1, 2017. Published June 2017. Originally approved in 1998. Last previous edition approved in 2013 as F1862/F1862M – 13. DOI: 10.1520/F1862_F1862M-17. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

YY 1293.5-2017 接触性创面敷料　第5部分：藻酸盐敷料

Contacting wound dressing—Part 5:Alginate dressing

YY/T 1477.4-2017 接触性创面敷料性能评价用标准试验模型第4部分：评价创面敷料潜在粘连性的体外模型

Standard test model for performance evaluation of contact wound dressings Part 4: In vitro model for evaluating the adhesive potential of wound dressings

ASTM E1396-90(2017) 油树脂敏感性评价标准测试方法

1.1 This test method describes standardized procedures for the sensory evaluation of heat in oleoresin capsicums ranging from 100 000 to 1 000 000 Scoville heat units (S.H.U.). 1.2 This test method is intended as an alternative to the Scoville heat test, but results can be expressed in Scoville heat units (see ASTA Method 21.0 and ISO 3513). 1.3 This test method does not apply for ground red pepper, low heat chili peppers, or chili powder. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in Section 8.

Standard Test Method for Sensory Evaluation of Oleoresin Capsicum

ASTM F2299/F2299M-03(2017) 用于确定医用面罩材料初始效率的标准测试方法使用乳胶球进行颗粒渗透

1.1 This test method establishes procedures for measuring the initial particle filtration efficiency of materials used in medical facemasks using monodispersed aerosols. 1.1.1 This test method utilizes light scattering particle counting in the size range of 0.1 to 5.0 µm and airflow test velocities of 0.5 to 25 cm/s. 1.2 The test procedure measures filtration efficiency by comparing the particle count in the feed stream (upstream) to that in the filtrate (downstream). 1.3 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way. 1.4 The following precautionary caveat pertains only to the test methods portion, Section 10, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 1.5 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.

Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

YY/T 1477.2-2016 接触性创面敷料性能评价用标准试验模型 第2部分：评价促创面愈合性能的动物烫伤模型

Standard test model for evaluation of performance of contact wound dressings Part 2: Animal burn model for evaluation of wound healing promoting properties

YY/T 1477.3-2016 接触性创面敷料性能评价用标准试验模型 第3部分:评价液体控制性能的体外创面模型

YY/T 1477的本部分适用于高渗出液创面的敷料，规定了水平体位创面和垂直体位创面两种体外模型，分别从吸收液体和透过水蒸气两个方面来评价创面敷料在高渗出液情况下对创面渗出液的液体控制性能。

Standard test models for primary wound dressing performance evaluation.Part 3:In vitro wound model for fluid handling properties evaluation

YY/T 1500-2016 医疗器械热原试验 单核细胞激活试验 人全血ELISA法

Medical device pyrogen test Monocyte activation test Human whole blood ELISA method

YY/T 1293.4-2016 接触性创面敷料第4部分:水胶体敷料

YY/T 1293本部分规定了水胶体敷料的性能要求和试验方法。 本部分适用于片状无菌供应的水胶体敷料。 本部分不适用于糊剂、粉剂水胶体敷料。

Contacting wound dressing.Part 4:Hydrocolloid dressing

YY/T 1416.4-2016 一次性使用人体静脉血样采集容器中添加剂量的测定方法 第4部分:氟化物

YY/T 1416本部分规定了离子色谱法测定添加剂中含氟化物的一次性使用人体静脉血样采集容器(简称：采血管)中添加剂量的试验方法。 本部分适用于添加剂为氟化物／草酸盐、氟化物／EDTA、氟化物／肝素的采血管，可分别测定氟化物、草酸盐及EDTA的量，对于含有氟化物／肝素添加剂的采血管，肝素的量可按YY/T 1416.3中亚甲蓝分光光度法方法进行测定。

Test method for additive in single-use containers for human venous blood specimen collection.Part 4:Fluoride

YY/T 1465.5-2016 医疗器械免疫原性评价方法 第5部分：用M86抗体测定动物源性医疗器械中α-Gal抗原清除率

Methods for evaluating the immunogenicity of medical devices Part 5: Determination of α-Gal antigen clearance rate in animal-derived medical devices using M86 antibody

YY/T 1293.4--2016 接触性创面敷料 第4部分：水胶体敷料

Contact wound dressings Part 4: Hydrocolloid dressings

YY/T 1293.2-2016 接触性创面敷料.第2部分:聚氨酯泡沫敷料

YY/T 1293的本部分规定了聚氨酯泡沫敷料的要求。本部分适用于无菌供应的液体吸收层为聚氨酯泡沫的敷料。本部分不包括含银等抑菌剂和负压引流用聚氨酯泡沫敷料。

Contacting wound dressing.Part 2:Polyurethane foam dressing

YY/T 1283-2016 可吸收性明胶海绵

本标准规定了可吸收性明胶海绵(以下简称明胶海绵)的要求及试验方法。 本标准适用于以明胶为原料，无菌、不溶于水的可吸收性明胶海绵。

Absorbable gelatin sponge

YY/T 1293.1-2016 接触性创面敷料.第1部分:凡士林纱布

YY/T 1293的本部分规定了无菌供应的凡士林纱布的要求。本部分适用于由织物浸渍了白凡士林或黄凡士林构成的凡士林纱布。本部分不涉及含有抗生素药物的凡士林纱布的抗生素种类及其含量的要求。

Contacting wound dressing.Part 1: Paraffin gauze

YY/T 1416.2-2016 一次性使用人体静脉血样采集容器中添加剂量的测定方法.第2部分:柠檬酸钠

YY/T 1416的本部分给出了一次性使用人体静脉血样采集容器(以下简称：采血管)中柠檬酸钠添加剂量的测定方法。本部分适用于一次性使用人体静脉血样采集容器中非缓冲二水合物形式的柠檬酸钠及缓冲柠檬酸钠添加剂中柠檬酸钠的测定。

Test method for additive in single-use containers for human venous blood specimen collection.Part 2: Sodium citrate