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분야 | ISO/TC 84 : Devices for administration of medicinal products and catheters |
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적용범위 | This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior. The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation. This document is not applicable to: a) suction catheters; b) tracheal catheters; c) urethral catheters; NOTE See ISO 20696. d) ureteral stents, biliary stents, and other stents; NOTE See ISO 14630 and ASTM F1828‑97 for stents requirements. e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique; f) neuraxial catheters used for removal of cerebrospinal fluid; NOTE See ISO 20698. g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract; NOTE See ISO 20695. h) coatings. |
국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
페이지수 | 37 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO 20697:2018 | Sterile drainage catheters and accessory devices for single use | 2018-06-05 | 표준 |
관련상품이 존재하지 않습니다.
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