11.040.30 外科器械和材料 标准查询与下载
共找到 1261 条与 外科器械和材料 相关的标准，共 85 页
Disposable sterile vaginal dilator
- ICS
- 11.040.30
- CCS
- C36
- 发布
- 2020-03-31
- 实施
- 2021-04-01
Medical device embryo transfer catheter for human in vitro assisted reproductive technology
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2020-03-31
- 实施
- 2021-04-01
Disposable abdominal puncture device
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2020-02-26
- 实施
- 2021-03-01
Method for determination of 2-chloroethanol residues in disposable polyvinyl chloride infusion equipment
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2020-02-21
- 实施
- 2021-01-01
Disposable Cervical Dilators Part 2: Inflatable
- ICS
- 11.040.30
- CCS
- C36
- 发布
- 2020-02-21
- 实施
- 2021-01-01
Disposable Cervical Dilators Part 1: Progressive
- ICS
- 11.040.30
- CCS
- C36
- 发布
- 2020-02-21
- 实施
- 2021-01-01
1.1 This specification covers the chemistry requirements for wrought stainless steels used for the manufacture of surgical instruments. The data contained in Tables 1-4 of this specification, including typical hardness values, common heat treating cycles, and examples of selected stainless steels that have been used for surgical instruments, is provided for reference only. Mechanical property requirements, heat treating requirements, hardness requirements, and all other requirements except chemistry are governed by the appropriate material standards as referenced below or as agreed upon between the purchaser and supplier. 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 Stainless Steels for Surgical Instruments
- ICS
- 11.040.30
- CCS
- 发布
- 2020-02-01
- 实施
1.1 This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone. 1.2 Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFDs). As such, the relationship between the intramedullary reamer diameter and the IMFD’s diameter are considered. 1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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 Intramedullary Reamers
- ICS
- 11.040.30
- CCS
- 发布
- 2020-02-01
- 实施
本标准适用于增材制造医疗器械（不涵盖细胞、组织等生物活性物质的生物3D打印等特殊设计的医 疗器械）注册人、注册申请人及备案人
Good Manufacturing Practice for Additively Manufactured Medical Devices
- ICS
- 11.040.30
- CCS
- C 30
- 发布
- 2019-12-30
- 实施
- 2020-01-30
1.1 This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof. 1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for a specific application. Therefore properties of fabricated forms of this resin should be evaluated using appropriate test methods to assure safety and efficacy. 1.3 Although this resin has been used for specific implant applications in the United States, the use of this resin in medical devices should be restricted to non-implant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed. 1.4 The biocompatibility of plastic compounds made up of polyoxymethylene (acetal) resin containing colorants, fillers, processing aids, or other additives as well as polymer blends which contain polyacetal should not be assumed on the basis of resin biocompatibility alone. Their biocompatibility must be established by testing the final (end-use) compositions using evaluation methods appropriate for the intended applications. It should be noted that the types, test levels, and biological effects of extractives yielded by the additives contained in a compound or blend may also have to be evaluated for some end-use applications. 1.5 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard. 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 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. 1.8 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 Specification for Polyoxymethylene (Acetal) for Medical Applications
- ICS
- 11.040.30
- CCS
- 发布
- 2019-12-01
- 实施
Instruments for surgery — Scissors and shears — General requirements and test methods
- ICS
- 11.040.30
- CCS
- 发布
- 2019-11-25
- 实施
Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
- ICS
- 11.040.30
- CCS
- 发布
- 2019-11-25
- 实施
Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
- ICS
- 11.040.30
- CCS
- 发布
- 2019-11-25
- 实施
Instruments for surgery — Scissors and shears — General requirements and test methods
- ICS
- 11.040.30
- CCS
- 发布
- 2019-11-25
- 实施
Method for detecting molecular weight and molecular weight distribution of polylactic acid and its copolymers for surgical implants
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2019-10-23
- 实施
- 2020-10-01
Standard Specification for Wrought Stainless Steels for Surgical Instruments
- ICS
- 11.040.30
- CCS
- 发布
- 2019-09-15
- 实施
