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    ASTM F1541-17

    Standard Specification and Test Methods for External Skeletal Fixation Devices
    • 발행일 : 2017-09-01
    • 발행기관 : ASTM
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상세정보

분야 13.01 : 의료기, 외과용 도구 및 장비
적용범위

1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification, which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs.

1.2 This specification describes ESFDs for surgical fixation of the skeletal system. It provides basic ESFD geometrical definitions, dimensions, classification, and terminology; material specifications; performance definitions; test methods; and characteristics determined to be important to the in-vivo performance of the device.

1.3 This specification includes a terminology and classification annex and five standard test method annexes as follows:

1.3.1 Classification of External Fixators—Annex A1.

1.3.2 Test Method for External Skeletal Fixator Connectors—Annex A2.

1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements—Annex A3.

1.3.4 Test Method for External Skeletal Fixator Joints—Annex A4.

1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements—Annex A5.

1.3.6 Test Method for External Skeletal Fixator Subassemblies—Annex A6.

1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies—Annex A7.

1.4 A rationale is given in Appendix X1.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 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

1.7 The following safety hazards caveat pertains only to the test method portions (Annex A2 – Annex A6):

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.
국제분류(ICS)코드 11.040.40 : 외과. 보철술. 교정술용 이식
페이지수 33
Edition 17

이력정보

No. 표준번호 표준명 발행일 상태
1 ASTM F1541-24상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2024-08-15 표준
2 ASTM F1541-24 REDLINE상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2024-08-15 표준
3 ASTM F1541-17상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2017-09-01 구판
4 ASTM F1541-17 REDLINE상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2017-09-01 구판
5 ASTM F1541-02(2015)상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2015-09-01 구판
6 ASTM F1541-02(2011)e1상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2011-10-01 구판
7 ASTM F1541-02(2011)상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2011-10-01 구판
8 ASTM F1541-02(2007)e1상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2007-06-15 구판
9 ASTM F1541-02(2007)상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2007-06-15 구판
10 ASTM F1541-99상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2002-04-10 구판
11 ASTM F1541-00상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2002-04-10 구판
12 ASTM F1541-01상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2002-04-10 구판
13 ASTM F1541-02상세보기 Standard Specification and Test Methods for External Skeletal Fixation Devices 2002-04-10 구판

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