IEC 60601-2-45 Ed. 3.2:2022 (b)
医用電気機器－第2-45部：乳房用X線機器及び定位乳房撮影装置の基礎安全及び基本性能の特定要求事項
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
発行年月日：
2022-08-02
状態：
有効
邦訳版：
無
英語 228ページ
146,300 円（税込） 本体価格：133,000円
- 規格概要
-
IEC 60601-2-45:2011+AMD1:2015+AMD2:2022 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.全文を表示する
| TC |
TC 62/SC 62B |
|---|---|
| ICS |
11.040.50 |
| 備考 |
