11.040.20 输血、输液和注射设备 标准查询与下载

ASTM F2394-07(2022) 安装在输送系统上的球囊扩张血管支架的安全性测量指南

1.1 This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloonexpandable stent delivery systems. 1.2 This guide covers the laboratory determination of the shear force required to displace or dislodge a balloonexpandable endovascular stent mounted on a delivery system. The guide proposes a set of options to consider when testing stent securement. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. An example test apparatus is given in 7.1. 1.3 This guide covers in vitro bench testing characterization only. Measured levels of securement and product design/ process differentiation may be particularly influenced by selections of pre-test treatments, securement test type (for example, stent gripping method), and test endpoint. In vivo characteristics may also differ from in vitro results. 1.4 This guide does not cover all possible pre-test treatments, stent securement tests, or test endpoints. It is intended to provide a starting point from which to select and investigate securement test options. 1.5 This guide does not specify a method for mounting the stent onto the delivery system. 1.6 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 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 Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System

ASTM F2081-06(2022) 血管支架尺寸属性的表征和表示的标准指南

1.1 This guide covers the identification of and recommended measurement methods for those dimensional attributes of vascular stents that are deemed relevant to successful clinical performance. The delivery system packaged with and labeled specifically for use during the placement of the stent is also included within the scope of this guide. 1.2 This guide addresses only the dimensional characteristics of stents. Material property and stent functional characteristics are not addressed herein. All dimensional characteristics described in this guide refer to in vitro (“bench-top”) characterization. Because of variable patient factors, for example, vessel compliance, the actual in vivo characteristics may be slightly different. 1.3 This guide includes recommendations generally applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents or polymeric or biodegradable stents, although the application of this guide to those products is not precluded. 1.4 While they are not specifically included within the scope of this guide, stents indicated for placement in nonvascular locations, such as the esophagus or bile duct, also might be characterized by the methods contained herein. Likewise, this guide does not include recommendations for endovascular grafts (“stent-grafts”) or other conduit devices commonly used to treat aneurysmal disease or peripheral vessel trauma or to provide vascular access, although some information included herein may be applicable to those devices. 1.5 This guide does not include recommendations for balloon catheters sold as stand-alone angioplasty catheters, even though some of those catheters may be used for the delivery of unmounted stents supplied without a delivery system. Requirements for angioplasty catheters are contained in standards ISO 10555-1 and ISO 10555-4. 1.6 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.6.1 The units of measurements used throughout this guide reflect the hybrid system in common clinical use in the United States as of the time of the original approval of this guide. Since a primary purpose of this guide is to promote uniformity of labeling to facilitate the selection of devices by clinical users, the units most preferred by users were selected for this guide. Where those units are not SI units, or derivatives thereof, SI units are provided in parentheses. 1.7 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 Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ASTM F2079-09(2022) 测量气球可膨胀支架固有弹性反冲的标准试验方法

1.1 The purpose of this test method is to quantify the percentage by which the diameter of a stent decreases from its expanded diameter while still on the delivery balloon to its relaxed diameter after deflating the balloon. This test method is appropriate for stents manufactured from a material that is plastically deformed when the stent’s diameter is increased from its predeployed size to its postdeployed size by mechanical means. This test method may be performed in air at room temperature unless there is a known temperature dependence of the material, in which case, the temperature at which the test is conducted shall be stated in the report. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 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 Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

BS EN ISO 8536-3:2009+A1:2022 医用输液设备 输液瓶铝盖

1   Scope This part of ISO 8536 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536‑1.

Infusion equipment for medical use - Aluminium caps for infusion bottles

T/CI 077-2022 —次性使用无菌止血夹使用规范

4　使用条件 4.1　止血夹应采用环氧乙烷气体灭菌处理，仅供一次性使用。 4.2　止血夹应与活检通道≥2.8 mm的胃镜和结肠镜等消化内窥镜配套使用。 4.3　释放前，夹片不宜打开、闭合超过五次，以便止血夹在病变部位重新定位夹持。 5　使用前注意事项 5.1　止血夹在通过弯曲的活检通道时可能会引起夹钳部与输送部分离或损坏的现象，并可能扭结或损坏的潜在风险。如出现此情况则不得使用。 5.2　对处于闭合状态的夹钳部施加轴向拉力可能会引起夹钳部与输送部分离现象，并可能出现输送部扭折甚至损坏的情况。如出现此情况则不得使用。 5.3　当内窥镜在体内角度过大不便器械通过时，需要将内窥镜拉直或打直以便器械通过，通过后再将内窥镜状态恢复以便进行治疗。如出现此情况则不得使用。 5.4　止血夹为一次性使用无菌医疗器械产品，供货时处于无菌状态，使用前应仔细检查，确保器械本身的无菌包装在运输过程中均未损坏。如出现此情况则不得使用。 5.5　止血夹旋转（Y）和不旋转（N）的适用条件一致。

Specification for use of sterile disposable hemostatic clips

EN ISO 8362-2:2015/A1:2022 注射容器和附件.第2部分:注射瓶用瓶塞 包含修改件A1,2022

Injection containers and accessories - Part 2: Closures for injection vials - Amendment 1 (ISO 8362-2:2015/Amd 1:2022)

EN ISO 8536-3:2009/A1:2022 医用输液器具.第3部分:输液瓶铝盖 包含修改件A1,2022

Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles - Amendment 1 (ISO 8536-3:2009/Amd 1:2022)

T/CAMDI 080-2022 13C-尿素呼气试验质控方法

本文件规定了13C-尿素呼气试验的使用管理，包括但不限于试验场所、试验人员、试验试剂、试验设备、试验质量控制方法、试验流程、检测结果判读、药品不良反应等多个方面。适用于开展13C-尿素呼气试验检测的各级医疗机构。 本文件适用于非分光中红外（NDIR）光谱法开展的13C-尿素呼气试验。

13C -Urea Breath Test Quality Control Methods

ISO 8362-2:2015/Amd 1:2022 注射容器和附件.第2部分:注射瓶封口.修改件1

Injection containers and accessories — Part 2: Closures for injection vials — Amendment 1

T/CAMDI 076-2022 医疗器械用聚砜材料的分子量及分布的测定 凝胶色谱法

聚砜树脂是以双酚A和4，4’-二氯二苯砜为起始原料，主要经由成盐、缩聚等反应制备而成的一种热塑性树脂。由于具有优异的韧性、耐高温性和良好的耐化学稳定性，聚砜树脂可应用于航空航天、电线电缆、机械、食品容器、家电和汽车等多种领域。尤其是，聚砜树脂对蒸汽、环氧乙烷、γ射线、等离子体等灭菌方法表现出良好的耐受性和抗蠕变能力，且能够在承受多次的杀菌循环后仍然保留优异的力学性能。与此同时，聚砜树脂还兼具有优良的生物相容性、成膜性和高度可控的孔径分布，使得其在血液透析膜、血浆分离器、血液浓缩器和医疗器械核心构件等高端医用领域得到了广泛的实际应用。在加工、制备这些高端医疗产品时，聚砜树脂的分子量及其分布会对分子链间相互作用力和聚集行为产生影响进而显著影响其物理性能与使用性能。以用于血液透析的中空纤维膜制备为例，在其它制备工艺都相同的条件下，采用不同分子量（包括数均分子量和重均分子量）聚砜树脂制备的中空纤维膜，其微结构、孔隙率、拉伸性能差异巨大（Richard A. Ward等人, Materials Science of Synthetic Membranes，1985，Chapter，5，99-118；牟倡骏等人，膜科学与技术，2018，1，129-135）；另一方面，若分子量分布较宽，也会对聚砜的可纺性能和纤维强度产生不利的影响。因而，不仅需要在聚砜树脂的合成过程中对其分子量及其分布加以控制，而且还要对用于制备血液透析膜、血浆分离器和血液浓缩器等聚砜专用料的分子量及其分布进行准确测定。虽然，聚砜专用料的分子量及其分布能够使用凝胶渗透色谱技术进行评价；但是，国内缺少专门用于血液透析膜、血浆分离器和血液浓缩器等聚砜专用料的相关规范文件和检验检测标准。在此背景下，制定相关检验检测标准对保障医疗器械安全性和性能稳定性具有十分重要意义。  本文件以凝胶渗透色谱分析方法（GPC）作为基本测试方法，用于测定血液透析膜、血浆分离器和血液浓缩器等聚砜专用料的分子量及其分布，并给出相关的试验测定程序。 

Gel chromatography method for molecular weight and distribution of polysulfone specialty for medical devices

T/CAMDI 077-2022 医用苯乙烯类热塑性弹性体中双环戊二烯（DCPD）残留量测定 气相色谱法

医用苯乙烯类热塑性弹性体(TPE-S)可与许多材料混合，有着极为广泛的应用范围，如药物输注和存储器械、大输液软袋、静脉营养输液袋等。在TPE-S合成过程中通常引入加氢催化剂双环戊二烯二氯化钛，加氢催化剂在胶液后处理过程中分解产生双环戊二烯，造成在TPE-S中双环戊二烯残留，在临床使用过程中器械接触的介质的多样性和复杂性可能会导致残留双环戊二烯迁移，可能对人体存在安全风险，可以刺激眼睛、皮肤、呼吸道及消化道系统，可以抑制中枢神经系统，动物试验中曾发现对大鼠的肾有伤害。 多种分析方法可用于测定苯乙烯类热塑性弹性体制作的输注和存储器具中残留双环戊二烯（DCPD），典型的方法包括气相色谱法（GC）、气相色谱/质谱仪联用法（GC/MS）等。本文件以GC作为基本方法，并给出试验程序。

Test method for residual of dicyclopentadiene from medical styrenic thermoplastic elastomer gas chromatography method

T/CAMDI 078-2022 医用聚氨酯材料中残留1,4-丁二醇（BDO）单体测定 气相色谱-质谱法（GC-MS）

医用聚氨酯可分为聚酯型和聚醚型，主要有聚酯/聚醚多元醇、异氰酸酯、扩链剂、各类助剂（抗氧剂、润滑剂）等制备得到。医用聚氨酯材料具有优良的生物相容性、可黏合性和抗血栓性，同时还具有优良的力学性能，可广泛应用于人工心脏、肾脏、人造皮肤、绷带、辅料、药物控释、介入治疗导管、计划生育用品等。在医用聚氨酯合成过程中通常引入单体1,4-丁二醇作为扩链剂，上述引入的单体1,4-丁二醇可能在聚氨酯中存在残留或聚氨酯原料在加工成型中分解产生的1,4-丁二醇。 多种分析方法可用于测定医用聚氨酯材料中残留的1,4-丁二醇（BDO）单体的测定，典型的方法包括气相色谱法（GC）、气相色谱/质谱仪联用法（GC/MS）等。本文件以GC/MS作为基本方法，并给出试验程序。 

Test method for residual of 1,4-Butanediol from medical polyurethane materials gas chromatography mass spectrometry method

YY/T 0821-2022 一次性使用配药用注射器

Dispensing syringe for single use

ASTM F2077-22 椎间融合器的标准试验方法

1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment. 1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies. 1.3 The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies. 1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface. 1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4). 1.6 Guidelines are established for measuring displacements, determining the yield force or moment, and evaluating the stiffness and strength of the intervertebral body fusion device assemblies. 1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations. 1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.9 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.10 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 Methods for Intervertebral Body Fusion Devices

YY/T 0612-2022 一次性使用人体动脉血样采集器(动脉血气针)

Disposable human arterial blood sample collector (arterial blood gas needle)

ISO 8536-3:2009/Amd 1:2022 医用输液设备.第3部分:输液瓶用铝盖.修改件1

Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles — Amendment 1

ASTM ISO/ASTM51939-17(2022) 血液辐照剂量测定的标准实施规程

Standard Practice for Blood Irradiation Dosimetry

ASTM ISO/ASTM 51939-17(2022) 血液照射剂量法的标准实践

1.1 This practice outlines the irradiator installation qualification program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation processing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range. 1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137 Cs and 60 Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy. 1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV. 1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated (see ISO/ASTM Guide 51539). 1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for dosimetry performed for blood irradiation. It is intended to be read in conjunction with ISO/ASTM Practice 52628. 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, health, and environmental 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 Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Blood Irradiation Dosimetry

YY/T 0296-2022 一次性使用注射针 识别色标

Disposable injection needle identification color code

YY/T 0321.1-2022 一次性使用麻醉穿刺包

Disposable anesthesia puncture kit