11.040.30 外科器械和材料 标准查询与下载

IEC 60601-2-2:2017 医用电气设备第2-2部分:高频手术设备和高频手术附件的基本安全和基本性能的特殊要求

Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223. HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-COAGULATION@ or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.

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

YY/T 1564-2017 心血管植入物肺动脉带瓣管道体外脉动流性能测试方法

Test method for in vitro pulsating flow performance of cardiovascular implant pulmonary artery valved conduits

YY/T 1568-2017 子宫托

pessary

YY/T 0686-2017 医用镊

medical forceps

YY/T 1532-2017 医疗器械生物学评价纳米材料溶血试验

Medical device biological evaluation nanomaterials hemolysis test

YY/T 1535-2017 人类体外辅助生殖技术用医疗器械生物学评价人精子存活试验

Biological evaluation of medical devices for human in vitro assisted reproductive technology and human sperm survival test

YY/T 1555.1-2017 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1部分：易挥发性物质限量要求

Specific requirements for silicone gel-filled breast implants Performance requirements for silicone gel fillers Part 1: Limit requirements for volatile substances

ASTM F2026-17 聚醚醚酮（PEEK）聚合物用于外科植入物应用的标准规范

1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pellets, powder, fabricated forms, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. 1.2 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification. 1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices. 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 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. 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. 1.6 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 Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

ASTM F564-17 金属骨钉的标准规格和试验方法

1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. 1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples: 1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples—Annex A1. 1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples—Annex A2. 1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples—Annex A3. 1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples—Annex A4. 1.3 The values stated in SI units are to be regarded as standard. Any other units of measurement included in this standard are shown for reference only. 1.4 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods. 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, health and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 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 and Test Methods for Metallic Bone Staples

GSO ASTM D3579:2016 彭罗斯型橡胶手术引流管的标准规范

1.1 This specification covers Penrose-type rubber tubes used in performing certain surgical drainage procedures. 1.2 The specification provides for packaged sterile rubber tubes and packaged or bulk nonsterile rubber tubes. 1.3 This standard does not purport to address all of the safety problems, 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.

Standard Specification for Rubber Surgical Drainage Tubes, Penrose-Type

DIN 13122:2016 医疗器械.1×1带齿直式钩钳

Medical instruments - Tenaculum forceps 1 × 1 teeth, straight

DIN 13137:2016 医疗器械.弗里契式腹壁牵开器

Medical instruments - Abdominal retractor type Fritsch

DIN 13123:2016 医疗器械.2×2带齿直式双爪钳

Medical instruments - Vulsellum forceps 2×2 teeth, straight

DIN 13130:2016 医疗器械.Maier型弯形敷料钳

Medical instruments - Dressing forceps type Maier, curved

DIN 13176:2016 医疗器械.器官夹持钳

Medical instruments - Organ grasping forceps

DIN 13173:2016 医疗器械.敷料钳

Medical instruments - Dressing forceps

DIN 13177:2016 医疗器械.Randall型肾结石钳

Medical instruments - Kidney stone forceps type Randall

DIN 13190:2016 医疗器械.Liston型截骨钳

Medical instruments - Bone cutting forceps type Liston

DIN 13129:2016 医疗器械.Maier型直式敷料钳

Medical instruments - Dressing forceps type Maier, straight

DIN 13192:2016 医疗器械.Ruskin型咬骨钳

Medical instruments - Rongeur type Ruskin