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    ASTM F543-13e1

    Standard Specification and Test Methods for Metallic Medical Bone Screws
    • 발행일 : 2013-05-01
    • 발행기관 : ASTM
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분야 13.01 : 의료기, 외과용 도구 및 장비
적용범위

1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.

1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:

1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.

1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.

1.2.3 Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.

1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.

1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.

1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.

1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.

1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.

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

1.5 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required.

1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.
국제분류(ICS)코드
페이지수 22
Edition 13e1

이력정보

No. 표준번호 표준명 발행일 상태
1 ASTM F543-23상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2023-06-01 표준
2 ASTM F543-17상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2017-03-01 구판
3 ASTM F543-13e1상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2013-05-01 구판
4 ASTM F543-13상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2013-05-01 구판
5 ASTM F543-07e2상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2007-06-01 구판
6 ASTM F543-07상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2007-06-01 구판
7 ASTM F543-07e1상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2007-06-01 구판
8 ASTM F543-02상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2002-04-10 구판
9 ASTM F543-01상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2002-04-10 구판
10 ASTM F543-01e1상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2002-04-10 구판
11 ASTM F543-98상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2002-04-10 구판
12 ASTM F543-00상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2002-04-10 구판
13 ASTM F543-02e1상세보기 Standard Specification and Test Methods for Metallic Medical Bone Screws 2002-04-10 구판

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