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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- 발행일 : 2016-04-01
- 발행기관 : ASTM
상세정보
| 분야 | 13.01 : 의료기, 외과용 도구 및 장비 |
|---|---|
| 적용범위 | 1.1 This practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials for surgical implants. It assesses the effects of the material on animal tissue in which it is implanted. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or soft tissue in excess of 30 days and will remain unabsorbed. It is recommended that short-term assays, according to Practice F763, first be performed. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials will consist of any one of the metal alloys in Specifications F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648 or USP polyethylene negative control. 1.2 This practice is a combination of Practice F361 and Practice F469. The purpose, basic procedure, and method of evaluation of each type of material are similar; therefore, they have been combined. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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 | 5 |
| Edition | 04(2016) |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F981-23상세보기 | Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices | 2023-09-01 | 표준 |
| 2 | ASTM F981-04(2010)상세보기 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone | 2010-06-01 | 구판 |
| 3 | ASTM F981-04상세보기 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone | 2004-05-01 | 구판 |
| 4 | ASTM F981-99(2003)상세보기 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone | 2003-11-01 | 구판 |
| 5 | ASTM F981-99상세보기 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone | 1999-05-10 | 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 F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
- ASTM F748-16 REDLINE - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
추천 상품
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- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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