11.040.30 外科器械和材料 标准查询与下载

KS P 6105-2018 导管

Catheters

DIN 13111:2018 医疗器械.绷带剪

The project defines dimensions and marking of Bandage scissors, as used in surgery and public health service.

Medical instruments - Bandage scissors

ASTM F2063-18 医疗器械和外科植入物用变形镍钛形状记忆合金的标准规范

1.1 This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubes containing nominally 54.5to 57.0-weight percent nickel and used for the manufacture of medical devices and surgical implants. 1.2 Requirements are for mill product, measuring 5.50 to 94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill product is not intended to have the final shape, final surface finish, or final properties of the medical device, implant, or their components. Finished NiTi cold-worked tube should be considered under Specification F2633. 1.3 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. 1.4 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 Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

EN IEC 60601-2-2:2018 医用电气设备 第2-2部分：高频手术设备和高频手术附件基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

ASTM F3260-18 用于确定医用纺织品弯曲刚度的标准测试方法

1.1 This test method covers the measurement of flexural stiffness properties of medical textiles (for example, surgical mesh, films, and membranes). Bending length is measured and flexural rigidity is calculated. 1.2 This test method may be used for absorbable or nonabsorbable medical textiles. 1.3 This test method measures the flexural stiffness at room temperature in air and, if used directly, may not provide an accurate measure of in-vivo behavior for implantable medical textiles. 1.4 This test method is not suitable for testing tubular samples. 1.5 The values stated in SI units are to be regarded as standard. Values in parentheses are for information only. 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 Test Method for Determining the Flexural Stiffness of Medical Textiles

ASTM F2066-18 用于外科植入物应用的锻造钛-15钼合金的标准规范（UNS R58150）

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants (1).2 1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inchpound 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 each other. Combining values from the two systems may result in non-conformance with the standard. 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.

Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

ASTM F565-04(2018) 矫形外科植入物和器械的护理和处理标准操作规程

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

ASTM F1611-00(2018) 髓内钉的标准规格

Standard Specification for Intramedullary Reamers

ASTM F1089-18 手术器械腐蚀的标准试验方法

1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of new and reusable surgical instruments fabricated from stainless steel alloys, such as, but not limited to, those listed in Specification F899. 1.2 Instruments containing stainless steel materials that are exclusive to the following shall use the boil test and the copper sulfate test: austenitic materials (Class 3), precipitation hardening materials (Class 5), and ferritic materials (Class 6) containing equal or greater than 16 % chromium. 1.3 Instruments containing any of the following stainless steel materials shall use the boil test: martensitic materials (Class 4) and ferritic materials (Class 6) containing less than 16 % chromium. 1.4 The copper sulfate test is used to detect the presence of free iron on the surface of materials. 1.5 The copper sulfate test as described in 6.2 is not recommended for martensitic materials or for ferritic materials containing less than 16% chromium because these steels may give a positive indication irrespective of the presence or absence of anodic surface contaminants (see X1.5). 1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardening materials to detect surface imperfections, free iron, or other anodic surface contaminants on stainless steel. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 Test Method for Corrosion of Surgical Instruments

YY 0645-2018 连续性血液净化设备

Continuous blood purification equipment

KS P 2002-2017 医用刀具

Medical knives

KS P 3501-2017 骨锉

Bone files

YY/T 1591-2017 人类EGFR基因突变检测试剂盒

本标准规定了人类表皮生长因子受体(Human epidermal growth factor Receptor，EGFR)基因突变检测试剂盒的要求、试验方法、标签和使用说明书、包装、运输和贮存。 本试剂盒适用于定性检测EGFR基因突变。本试剂盒不适用于EGFR基因拷贝数变化检测。 本试剂盒适用于肿瘤组织或者细胞石蜡包埋切片、新鲜冰冻肿瘤组织提取的DNA样本中EGFR基因突变检测，外周血(浆)中EGFR基因突变检测可参照并制定符合外周血(浆)中EGFR基因突变检测所需的技术要求。 本试剂盒适用于人类EGFR基因突变检测试剂盒，采用的技术方法有荧光PCR法、流式荧光杂交法、荧光PCR熔解曲线法、焦磷酸测序法和Sanger测序法等。本试剂盒不适用于检测EGFR基因拷贝数变化的荧光原位杂交法；本试剂盒不适用于检测EGFR基因突变的高通量测序法。

Human epidermal growth factor receptor(EGFR) mutation detection kit

DIN 13171:2017 医疗器械.Adson-Brown外科组织镊

The project defines dimensions and marking of tissue forceps type Adson-Brown, angled to side, as used in surgery and public health service.

Medical instruments - Tissue forceps type Adson-Brown

DIN 13112-1:2017 医疗器械.第1部分:不镶硬质合金的解剖剪

The project defines dimensions and marking of scissors for preparations without carbide inserts, as used in surgery and public health service.

Medical instruments - Part 1: Scissors for preparations without carbide inserts

DIN 13172:2017 医疗器械.德巴基氏血管镊子

Standardization of dimensions, material, requirements, designation and marking of the vessel forceps type De Bakay for use in surgery.

Medical instruments - Vessel forceps type De Bakey

DIN 13451:2017 医疗器械.约瑟夫氏剪刀

The project defines dimensions and marking of scissors type Joseph, angled to side, as used in surgery, public health service or armed forces. The project defines dimensions and marking of scissors type Joseph, angled to side, as used in surgery and public health service.

Medical instruments - Scissors type Joseph

DIN 13452:2017 医疗器械.基尔氏剪刀

The project defines dimensions and marking of scissors type Kilner, angled to side, as used in surgery, public health service.

Medical instruments - Scissors type Kilner

DIN 96156:2017 医疗仪器.叶片弯Kocher型牵开器

This standard defines dimensions and marking of retractors type Kocher, blade curved, as used in surgery and public health service.

Medical instruments - Retractor type Kocher, blade curved

DIN 96146:2017 医疗仪器.Brunner型牵开器

This standard defines dimensions and marking of retractors type Brunner, as used in surgery and public health service.

Medical instruments - Retractors type Brunner