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ISO 20698:2018
Catheter systems for neuraxial application — Sterile and single-use catheters and accessories- 발행일 : 2018-07-26
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 84 : Devices for administration of medicinal products and catheters |
|---|---|
| 적용범위 | This document specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications. This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate conformity with these requirements. Catheters for neuraxial applications are intended to administer medications directly into neuraxial sites, to deliver wound infiltration analgesia and to other regional analgesia procedures or to monitor or remove fluids from neuraxial sites for therapeutic or diagnostic purposes. NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space and the epi-, extra-, or peri-dural space (applications mentioned are just examples and not an exhaustive list). In neuraxial application, anaesthetics/analgesics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the brachial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents. NOTE 2 Local anaesthesia/analgesia injected hypodermically and systemic injection of anaesthetics are not considered neuraxial applications. This document is applicable to the following types of devices: — spinal/epidural catheter systems; — spinal/epidural port catheter systems; — peripheral nerve block catheter systems; — wound infusion catheter systems (also known as catheters for Surgical Site Continuous Analgesia). This document is not applicable to: — pumps and other devices intended to deliver medications through these catheter systems; — catheters generically intended to administer substances into the body which are not intended to interact directly with the nervous system, but which have an indirect effect on nervous system (e.g. cannula needles); — drainage catheters for any other application than neuraxial. |
| 국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
| 페이지수 | 20 |
| Edition | 1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 20698:2018상세보기 | Catheter systems for neuraxial application — Sterile and single-use catheters and accessories | 2018-07-26 | 표준 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- ISO 20697:2018 - Sterile drainage catheters and accessory devices for single use
- ISO 8536-14:2016 - Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
- ISO 14971:2019 - Medical devices — Application of risk management to medical devices
- ISO 20696:2018 - Sterile urethral catheters for single use
- ISO 10993-7:2008/Amd 1:2019 - Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
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