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Standard Specification for Composition of Hydroxylapatite for Surgical Implants
| 분야 | 13.01 : 의료기, 외과용 도구 및 장비 |
|---|---|
| 적용범위 | 1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called hydroxylapatite, it must conform to this specification. (See Appendix X1.) 1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3)2 and by laboratory studies (4-6) . 1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacturing processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth. 1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F1088.) 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 | 3 |
| Edition | 03(2014) |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F1185-23 | Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants | 2023-04-15 | 표준 |
| 2 | ASTM F1185-23 REDLINE | Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants | 2023-04-15 | 표준 |
| 3 | ASTM F1185-03(2014) | Standard Specification for Composition of Hydroxylapatite for Surgical Implants | 2014-03-01 | 구판 |
| 4 | ASTM F1185-03(2009) | Standard Specification for Composition of Hydroxylapatite for Surgical Implants | 2009-06-15 | 구판 |
| 5 | ASTM F1185-03 | Standard Specification for Composition of Hydroxylapatite for Surgical Implants | 2003-04-10 | 구판 |
관련상품이 존재하지 않습니다.
ASTM F763-04(2016) - Standard Practice for Short-Term Screening of Implant Materials 상세보기
ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices 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 F1983-14 REDLINE - Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications 상세보기
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