IEC 60601-1-6 Ed. 3.0:2010 (b)
医用電気機器－第1-6部：基礎安全及び基本性能に関する一般要求事項－副通則：ユーザビリティ
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
発行年月日：
2010-01-27
状態：
有効
邦訳版：
有（ 英・日対訳版）
英語 51ページ
38,500 円（税込） 本体価格：35,000円
邦訳 54ページ
62,172 円（税込） 本体価格：56,520円
- 規格概要
-
IEC 60601-1-6:2010 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production.全文を表示する
| TC |
TC 62/SC 62A |
|---|---|
| ICS |
11.040 |
| 備考 | 邦訳版はEd.3.0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。 |
