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 for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
| 분야 | 13.01 : 의료기, 외과용 도구 및 장비 |
|---|---|
| 적용범위 | 1.1 This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants. 1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. 1.3 The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants. 1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3)2 and by laboratory studies (4, 5, 6). 1.5 The values stated in SI units are to be regarded as standard. 1.6 The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: 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 |
83.080.20 : 열가소성 수지재
11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 8 |
| Edition | 14 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F648-21 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2021-04-01 | 표준 |
| 2 | ASTM F648-21 REDLINE | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2021-04-01 | 표준 |
| 3 | ASTM F648-14 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2014-03-01 | 구판 |
| 4 | ASTM F648-14 REDLINE | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2014-03-01 | 구판 |
| 5 | ASTM F648-13 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2013-07-01 | 구판 |
| 6 | ASTM F648-10a | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2010-12-01 | 구판 |
| 7 | ASTM F648-10 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2010-09-15 | 구판 |
| 8 | ASTM F648-07e1 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2007-02-01 | 구판 |
| 9 | ASTM F648-07 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2007-02-01 | 구판 |
| 10 | ASTM F648-04 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2004-10-01 | 구판 |
| 11 | ASTM F648-00e1 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2000-05-10 | 구판 |
| 12 | ASTM F648-00 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | 2000-05-10 | 구판 |
관련상품이 존재하지 않습니다.
ASTM F1886/F1886M-16 - Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection 상세보기
ASTM F116-12(2016) - Standard Specification for Medical Screwdriver Bits 상세보기
ASTM D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems 상세보기
ASTM F88/F88M-15 - Standard Test Method for Seal Strength of Flexible Barrier Materials 상세보기
ASTM E2314-03(2014) - Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test) (Withdrawn 2021) 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
