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 Practice for Short-Term Screening of Implant Materials
| 분야 | 13.01 : 의료기, 외과용 도구 및 장비 |
|---|---|
| 적용범위 | 1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted. This is a rapid screening procedure for determining acceptability of candidate materials. 1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests) may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application. 1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues. 1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 provides guidance for the selection of appropriate methods for testing materials for a specific application. 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 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 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 4 |
| Edition | 04(2016) |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F763-22 | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials | 2022-09-01 | 표준 |
| 2 | ASTM F763-22 REDLINE | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials | 2022-09-01 | 표준 |
| 3 | ASTM F763-04(2016) | Standard Practice for Short-Term Screening of Implant Materials | 2016-04-01 | 구판 |
| 4 | ASTM F763-04(2010) | Standard Practice for Short-Term Screening of Implant Materials | 2010-06-01 | 구판 |
| 5 | ASTM F763-04 | Standard Practice for Short-Term Screening of Implant Materials | 2004-05-01 | 구판 |
| 6 | ASTM F763-99(2003) | Standard Practice for Short-Term Screening of Implant Materials | 2003-11-01 | 구판 |
| 7 | ASTM F763-99 | Standard Practice for Short-Term Screening of Implant Materials | 1999-05-10 | 구판 |
관련상품이 존재하지 않습니다.
ASTM F1983-14 REDLINE - Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications 상세보기
ASTM F981-04(2016) - Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone 상세보기
ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices 상세보기
ASTM F1185-03(2014) - Standard Specification for Composition of Hydroxylapatite for Surgical Implants 상세보기
ISO 7405:2018 - Dentistry — Evaluation of biocompatibility of medical devices used in dentistry 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
