관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
구판
판매
Standard Specification and Test Methods for Metallic Medical Bone Screws
| 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, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods. 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. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 22 |
| Edition | 17 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F543-23 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2023-06-01 | 표준 |
| 2 | ASTM F543-23 REDLINE | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2023-06-01 | 표준 |
| 3 | ASTM F543-17 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2017-03-01 | 구판 |
| 4 | ASTM F543-17 REDLINE | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2017-03-01 | 구판 |
| 5 | ASTM F543-13 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2013-05-01 | 구판 |
| 6 | ASTM F543-13e1 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2013-05-01 | 구판 |
| 7 | ASTM F543-07e2 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2007-06-01 | 구판 |
| 8 | ASTM F543-07e1 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2007-06-01 | 구판 |
| 9 | ASTM F543-07 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2007-06-01 | 구판 |
| 10 | ASTM F543-02e1 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2002-04-10 | 구판 |
| 11 | ASTM F543-00 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2002-04-10 | 구판 |
| 12 | ASTM F543-98 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2002-04-10 | 구판 |
| 13 | ASTM F543-01e1 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2002-04-10 | 구판 |
| 14 | ASTM F543-01 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2002-04-10 | 구판 |
| 15 | ASTM F543-02 | Standard Specification and Test Methods for Metallic Medical Bone Screws | 2002-04-10 | 구판 |
관련상품이 존재하지 않습니다.
ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants 상세보기
ASTM F1541-17 - Standard Specification and Test Methods for External Skeletal Fixation Devices 상세보기
ASTM F1147-05(2017)e1 - Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings 상세보기
ASTM F3122-14 - Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes 상세보기
ASTM F3049-14 - Standard Guide for Characterizing Properties of Metal Powders Used for Additive Manufacturing Processes 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
KS표준
핸드북
