IEC/TR 80002-1 Ed. 1.0:2009 (en)
医療機器ソフトウェア－第1部：医療機器ソフトウェアへのISO 14971の適用の手引
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
発行年月日：
2009-09-23
状態：
有効
邦訳版：
有（ 英・日対訳版）
英語 64ページ
66,412 円（税込） 本体価格：60,375円
邦訳 136ページ
104,907 円（税込） 本体価格：95,370円
| 規格概要 | IEC/TR 80002-1:2009(E) provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to medical device software with reference to IEC 62304:2006, Medical device software - Software life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006. IEC/TR 80002-1:2009(E) is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use. The content of these two standards provides the foundation for this technical report. It should be noted that even though ISO 14971 and this technical report focus on medical devices, this technical report may be used to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. IEC/TR 80002-1:2009 is not intended to be used as the basis of regulatory inspection or certification assessment activities. |
|---|---|
| TC |
TC 62/SC 62A |
| ICS |
11.040.01 |
| 備考 | 邦訳版はEd.1.0です。エディション(Ed.)についての詳細は、こちらをご覧下さい。 |
