Norm

ASTM F1541 - 02(2011)e1 en

Standard Specification and Test Methods for External Skeletal Fixation Devices

  • Deze norm is ingetrokken sinds 01-09-2015

73,70 89,18 Incl BTW

Over deze norm

Status Ingetrokken
Aantal pagina's 32
Gepubliceerd op 01-10-2011
Taal Engels

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 FixatorsAnnex A1.

1.3.2 Test Method for External Skeletal Fixator ConnectorsAnnex A2.

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

1.3.4 Test Method for External Skeletal Fixator JointsAnnex A4.

1.3.5 Test Method for External Skeletal Fixator Pin Anchorage ElementsAnnex A5.

1.3.6 Test Method for External Skeletal Fixator SubassembliesAnnex A6.

1.3.7 Test Method for External Skeletal Fixator/Constructs SubassembliesAnnex 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 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.

Details

ICS-code 11.120.20
Engelse titel Standard Specification and Test Methods for External Skeletal Fixation Devices
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