사업자등록증
해외표준
FAQ
장바구니
고객센터
해외표준 상세정보
관심표준 등록 : 표준업데이트 시 알림서비스
제공형태 더보기-
구판
판매
ASTM F2902-16e1
Standard Guide for Assessment of Absorbable Polymeric Implants- 발행일 : 2016-12-01
- 발행기관 : ASTM
상세정보
| 분야 | 13.02 : 긴급 의료 서비스; 수색 및 구조 |
|---|---|
| 적용범위 | 1.1 This guide describes general guidelines for the chemical, physical, mechanical, biocompatibility, and preclinical assessments of implantable synthetic polymeric absorbable devices. This guide also describes evaluation methods that are potentially useful and should be considered when assessing absorbable implants or implant components. 1.2 The described evaluations may assist a manufacturer in establishing the safety and effectiveness of an absorbable implant device. This listing of assessment methods may also be utilized to assist in establishing substantial equivalence to an existing commercially marketed device. However, these polymeric material-oriented guidelines do not necessarily reflect the total needs for any particular implant application (for example, orthopedic, cardiovascular, sutures, and dermal fillers), which may require additional and potentially essential application-specific evaluations. 1.3 This guide is intended to cover all forms of absorbable polymeric components and devices, including solid (for example, injection-molded) and porous (for example, fibrous) forms. This guide is also intended to cover devices fabricated from amorphous and/or semi-crystalline absorbable polymer systems. 1.4 This guide has been generated with principal emphasis on the evaluation of devices formed from synthetic polymers that degrade in vivo primarily through hydrolysis (for example, α-hydroxy-polyesters). Evaluation methods suggested herein may or may not be applicable to implants formed from materials that, upon implantation, are substantially degraded through other mechanisms (for example, enzymatically induced degradation). 1.5 This guide references and generally describes various means to assess absorbable materials, components, and devices. The user needs to refer to specific test methods for additional details. Additionally, some of the recommended test methods may require modification to address the properties of a particular device, construct, or application. 1.6 Adherence to all aspects of these guidelines is not mandatory, in that assessments and tests listed within this guide are not necessarily relevant for all absorbable implant systems and applications. 1.7 Absorbable polymers used as a matrix to control the in vivo release of bioactive agents (drugs, antimicrobials, and so forth) may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate a bioactive agent’s composition, loading, release kinetics, safety, and efficacy. 1.8 Composites of absorbable polymers with ceramics and/or metals may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate the composite’s other component(s). 1.9 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.10 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. 1.11 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 | 15 |
| Edition | 16e1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F2902-24상세보기 | Standard Guide for Assessment of Absorbable Polymeric Implants | 2024-10-15 | 표준 |
| 2 | ASTM F2902-24 REDLINE상세보기 | Standard Guide for Assessment of Absorbable Polymeric Implants | 2024-10-15 | 표준 |
| 3 | ASTM F2902-16e1상세보기 | Standard Guide for Assessment of Absorbable Polymeric Implants | 2016-12-01 | 구판 |
| 4 | ASTM F2902-16상세보기 | Standard Guide for Assessment of Absorbable Polymeric Implants | 2016-12-01 | 구판 |
| 5 | ASTM F2902-12상세보기 | Standard Guide for Assessment of Absorbable Polymeric Implants | 2012-12-01 | 구판 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- BS EN 13726-1:2002 - Test methods for primary wound dressings. Aspects of absorbency.
- ASTM F1635-16 REDLINE - Standard Test Method for
in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants - ASTM F3259-17 - Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
- ASTM F748-16 REDLINE - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
- ASTM D3039/D3039M-17 REDLINE - Standard Test Method for Tensile Properties of Polymer Matrix Composite Materials
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- 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
- KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
제공형태 닫기
PDF :
직접 파일 다운로드 및 인쇄(마이페이지 확인)보안PDF :
직접 파일 다운로드 및 인쇄(마이페이지 확인)* 단, 파일이동 및 복사 불가, 1회 다운로드 및 인쇄가능PRINT :
인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)BOOK :
인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)ZIP :
압축파일형태로 제공 (PDF, HTML, TXT, XLS 등으로 구성), 직접 파일 다운로드(마이페이지 확인)CD/DVD :
직접 파일 다운로드 및 인쇄(마이페이지 확인)DB :
별도 정보 제공HARDCOPY :
해외 배송 상품, 최대 3주 소요바인더 :
바인더 우편발송, 2~3일 소요온라인구독 :
WEB 접속 후 실시간 열람, 출력(1년간)