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ASTM F1541-00

Historical Revision

Standard Specification and Test Methods for External Skeletal Fixation Devices

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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 the standard.

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

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.


SDO ASTM: ASTM International
Document Number F1541
Publication Date April 10, 2002
Language en - English
Page Count 31
Revision Level 00
Supercedes
Committee F04.21
Publish Date Document Id Type View
Aug. 15, 2024 F1541-24 Revision
Sept. 1, 2017 F1541-17 Revision
Oct. 1, 2011 F1541-02R11E01 Revision
June 15, 2007 F1541-02R07E01 Revision
April 10, 2002 F1541-99 Revision
April 10, 2002 F1541-02 Revision
April 10, 2002 F1541-01 Revision
April 10, 2002 F1541-00 Revision
Sept. 1, 2015 F1541-02R15 Reaffirmation
Oct. 1, 2011 F1541-02R11 Reaffirmation
June 15, 2007 F1541-02R07 Reaffirmation