Cookies
We need your consent to use the individual data so that you can see information about your interests, among other things. Click "OK" to give your consent.
ASTM F1541-02(2007)e1
Standard Specification and Test Methods for External Skeletal Fixation Devices (Includes all amendments And changes 10/31/2011).
Automatically translated name:
Standard Specification and Test Methods for External Skeletal Fixation Devices
STANDARD published on 15.6.2007
The information about the standard:
Designation standards: ASTM F1541-02(2007)e1
Note: WITHDRAWN
Publication date standards: 15.6.2007
SKU: NS-50674
The number of pages: 31
Approximate weight : 93 g (0.21 lbs)
Country: American technical standard
Category: Technical standards ASTM
Annotation of standard text ASTM F1541-02(2007)e1 :
Keywords:
anchorage element, bending, bridge element, connector, external skeletal fixation device, fracture fixation, joints, modularity, orthopedic medical device, osteosynthesis, ring element, subassembly (frame), terminology, torsion, bending moments, connecting elements, connectors, external fixator, orthopedic device, stiffness, strength, bending, connecting elements, external fixator, joints, orthopedic device, range of adjustability, range of motion, stiffness, strength, torsion
Additional information
| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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. 1.3.2 Test Method for External Skeletal Fixator Connectors. 1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements. 1.3.4 Test Method for External Skeletal Fixator Joints. 1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements. 1.3.6 Test Method for External Skeletal Fixator Subassemblies. 1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies. 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): 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. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
