IEC 60601-2-43 Ed. 3.0:2022 (b)
医用電気機器－第2-43部：インタベンショナル処置のためのX線装置の基礎安全及び基本性能の特定要求事項
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
発行年月日：
2022-12-05
状態：
有効
邦訳版：
無
英語 126ページ
70,262 円（税込） 本体価格：63,875円
- 規格概要
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IEC 60601-2-43:2022 is available as IEC 60601-2-43:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-43:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:全文を表示する
- equipment for RADIOTHERAPY;
- equipment for COMPUTED TOMOGRAPHY;
- ACCESSORIES intended to be introduced into the PATIENT;
- mammographic X RAY EQUIPMENT;
- dental X RAY EQUIPMENT.
INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this document.
If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.
IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.
IEC 60601-2-43:2022 cancels and replaces the second edition published in 2010, Amendment 1:2017 and Amendment 2:2019. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-54:2022. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows:
| TC |
TC 62/SC 62B |
|---|---|
| ICS |
37.040.25 |
| 備考 |
