한국표준정보망(KSSN)

관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.

PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)

PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)

표준 판매

Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices

언어	제공형태	판매가격	선택
영어	PDF	101,100원
영어	PRINT	101,100원

장바구니 담기

상품이 장바구니에 담겼습니다.

장바구니로 이동

분야	ISO/TC 150/SC 2 : Cardiovascular implants and extracorporeal systems
적용범위	This document specifies the appropriate application of ISO 17327-1:2018 to coated endovascular prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement to ISO 25539-1, ISO 25539-2, ISO 25539-3, ISO 12417-1 and ISO/TS 17137. The following coatings are within the scope of ISO 17327-1 and addressed in this document for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide, such as TiO₂, and non-oxide, such as amorphous silicon carbide and diamond-like carbon). This document is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of ISO 17327-1, which is specifically directed to implant coatings. This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated, it is within the scope of this document. This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings.
국제분류(ICS)코드	11.040.40 : 외과. 보철술. 교정술용 이식
페이지수	11
Edition	1

No.	표준번호	표준명	발행일	상태
1	ISO 25539-4:2021	Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices	2021-11-12	표준