IEC 61326-2-6 Ed. 4.0:2025 (b)
・計測用,制御用及び試験室用の電気装置-電磁両立性(EMC)要求事項-第2-6 部:個別要求事項-体外診断用(IVD)医療機器
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment
発行年月日:
2025-06-18
状態:
有効
邦訳版:
無
英語 70ページ
58,630 円(税込) 本体価格:53,300円
- 規格概要
-
IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE.全文を表示する
BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.
NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE.
This edition includes the following significant technical changes with respect to the previous edition:
- Update of the document with respect to test levels and documentation.
| TC |
TC 65/SC 65A |
|---|---|
| ICS |
33.100.20 |
| 備考 | 邦訳版発行時にメール通知いたします。登録はこちら:登録フォーム |