11.040.30 外科器械和材料 标准查询与下载

ASTM F3395/F3395M-19 神经外科头固定装置的标准规范

1.1 This specification covers standards a manufacturer shall meet in the performance testing of neurosurgical head holder devices (skull clamps). 1.2 This specification covers neurosurgical head holder devices (skull clamps) made of metal (nonradiolucent) as well as neurosurgical head holder devices (skull clamps) made of plastic material (radiolucent). 1.3 This specification represents the best currently available test procedures and is a minimum safety and performance standard. 1.4 This specification covers only those neurosurgical head holders (skull clamps) intended for use on humans for neurosurgical and spinal clinical applications. This specification assumes the user is well trained in the procedures and use of these devices including selection of the correct device type and accessories. 1.5 This specification describes those devices commonly known as skull clamps and accessories, such as skull pins, attachments, and various adaptors. 1.6 This specification only describes head holder devices that provide rigid skeletal fixation of the skull by means of three skull pins that penetrate the outer surface or outer layers of the patient’s head during neurosurgical or spinal procedures (compare with Ref (1)).2 Two pins are typically located in a 2-pin rocker, whereas the force delivery component is equipped with a single pin. 1.7 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. The values given in parentheses are for information only. 1.8 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. 1.9 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 Specification for Neurosurgical Head Holder Devices

YY/T 1214-2019 人绒毛膜促性腺激素测定试剂盒

本标准规定了人绒毛膜促性腺激素定量标记免疫分析试剂盒的分类、要求、试验方法、标识、标签和使用说明书、包装、运输和贮存。本标准适用于以双抗体夹心法为原理定量测定人绒毛膜促性腺激素(HCG)的试剂盒(以下简称:HCG试剂盒)。包括以酶标记、(电)化学发光标记、(时间分辨)荧光标记等标记方法为捕获抗体,以微孔板、管、磁颗粒、微珠和塑料珠等为载体包被抗体,定量测定HCG的免疫分析试剂盒。本标准不适用于:a)胶体金标记HCG试纸条;b)用125I等放射性同位素标记的各类HCG放射免疫或免疫放射试剂盒。

Human chorionic gonadotrophin quantitative labelling immunoassay kit

YY/T 1550.2-2019 一次性使用输液器具与药物相容性研究指南 第2部分：可沥滤物研究 已知物

Guidelines for Compatibility Study of Disposable Infusion Sets and Drugs Part 2: Known Substances for Leachables Study

YY/T 1657-2019 胚胎植入前染色体非整倍体检测试剂盒（测序法）

Preimplantation Chromosomal Aneuploidy Detection Kit (Sequencing Method)

YY/T 0174-2019 手术刀片

Scalpel blade

YY/T 1628-2019 医用输液、输血器具用聚氯乙烯粒料

Polyvinyl chloride granules for medical infusion and blood transfusion equipment

YY 0174-2019 手术刀片

本标准规定了手术刀片的分类、要求、试验方法、检验规则、标志、包装、运输与贮存。 本标准适用于手术刀片(以下简称刀片)，该产品安装于手术刀柄上，作切割软组织用。

Scalpel blade

KS P ISO 7740:2018 手术仪器 - 带可拆卸刀片的手术刀 - 配件尺寸

Instruments for surgery — Scalpels with detachable blades — Fitting dimensions

KS P ISO 7740-2018(2023) 外科器械可拆卸刀片的手术刀配合尺寸

Instruments for surgery — Scalpels with detachable blades — Fitting dimensions

KS P ISO 7740-2018 手术仪器 - 带可拆卸刀片的手术刀 - 配件尺寸

Instruments for surgery — Scalpels with detachable blades — Fitting dimensions

YY/T 1555.2-2018 硅凝胶填充乳房植入物专用要求 硅凝胶填充物性能要求 第2部分：可浸提物质限量要求

Special Requirements for Silicone Gel Filled Breast Implants Performance Requirements for Silicone Gel Fillers Part 2: Limit Requirements for Leachable Substances

YY/T 1611-2018 人类免疫缺陷病毒抗体检测试剂盒（免疫层析法）

Human immunodeficiency virus antibody detection kit (immunochromatography)

YY/T 1639-2018 一次性使用聚氨酯输注器具二苯甲烷二异氰酸酯（MDI）残留量测定方法

Method for determination of diphenylmethane diisocyanate (MDI) residues in disposable polyurethane infusion equipment

YY/T 1629.2-2018 电动骨组织手术设备刀具 第2部分：颅骨钻头

Electric Bone Tissue Surgery Equipment Knives Part 2: Skull Drills

ASTM F2062-00(2018) 手术器械方形驱动互连标准规范

1.1 This specification applies to interconnections of surgical instruments used for drilling, tapping, driving, or placing of medical devices during surgery. 1.2 This specification includes dimensions and tolerances for both driving and driven elements. 1.3 The specifications given in ASME B107.4M-1995 are designed for industrial applications and are considered too loose for surgical applications. Springs used for industrial applications are generally made from carbon steel and are capable of higher loads than their stainless steel counterparts. The specifications given in this standard have been written to lessen the chance of accidental disengagement of surgical instruments. This accidental disengagement could injure the patient or end user, or damage or contaminate the instrument. 1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 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 Specification for Square Drive Interconnections on Surgical Instruments

YY/T 1629.1-2018 电动骨组织手术设备刀具 第1部分：磨头

Electric Bone Tissue Surgery Equipment Knives Part 1: Grinding Points

T/ZZB 0542-2018 一次性高频手术电极（电凝切割器）

本标准规定了一次性高频手术电极（电凝切割器）的术语和定义、分类、基本要求、技术要求、试验方法、检验规则及标识标签及使用说明书、包装、运输与贮存、质量承诺。 本标准适用于临床手术时与高频发生器或吸引装置配套使用，实现电凝、电切、刮扒、推剥及吸除功能的一次性高频手术电极（电凝切割器）(以下简称“手术电极”)。

Disposable high frequency active electrode surgical instrument (active electrode is intended to coagulate or cut )

T/ZZB 0502-2018 气管插管用视频喉镜

本标准规定了气管插管用视频喉镜（以下简称喉镜）的术语和定义、规格型号、基本要求、技术要求、检验方法、检验规则、标志、标签、使用说明书、包装、贮存与运输和质量承诺等。 本标准适用于气管插管用视频喉镜。

Video laryngoscopes for tracheal intubation

KS P 6105-2018 导管

Catheters

KS P 4902-2018 手术锯

Surgical saws