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ASTM F1541-02(2011)e1
Standard Specification and Test Methods for External Skeletal Fixation Devices
32 стр.
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138.84 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
ICS:
11.120.20 Wound dressings and compresses / Повязки на рану и компрессы
Сборник (ASTM):
13.01 Medical and Surgical Materials and Devices (I): E667 – F2477 / Медицинские и хирургические материалы и приборы (I): E667 - F2477
Тематика:
Medical Devices & Implants
Описание
Значение и использование

A1.4.1 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed.

Область применения

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.

Ключевые слова:
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; external fixation; four-point bending; orthopedic device; pins; rigidity; stiffness; strength; torsion; bend testing—;orthopedic medical devices; fatigue testing—;orthopedic medical devices; orthopedic medical devices—;external fixation devices; test methods—;surgical devices