IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Kehtiv alates 22.07.2020
Direktiivid või määrused
Standardi ajalugu
IEC 60601-1-6:2010+A1:2013+A2:2020 specifies a process for a manufacturer toanalyse, 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. This consolidated version consists of the third edition (2010), its amendment 1 (2013) and its amendment 2 (2020). Therefore, no need to order amendments in addition to this publication.
333,34 € koos KM-ga
333,34 € koos KM-ga
Standardi monitooring
Teised on ostnud veel
Põhitekst + muudatus

EVS-EN 62304:2006+A1:2015

Meditsiiniseadmete tarkvara. Tarkvara elutsükli protsessid
Uusim versioon Kehtiv alates 15.11.2019

EVS-EN ISO 11737-2:2020

Meditsiiniseadmete steriliseerimine. Mikrobioloogilised meetodid. Osa 2: Steriliseerimisprotsesside määratlemisel, valideerimisel ja hooldamisel teostatud steriilsustestid
Uusim versioon Kehtiv alates 02.06.2020

EVS-EN ISO 11737-1:2018

Tervishoiutoodete steriliseerimine. Mikrobioloogilised meetodid. Osa 1: Mikroobse populatsiooni määramine toodetel
Uusim versioon Kehtiv alates 15.02.2018

EVS-EN 868-5:2018

Lõppsteriliseeritud meditsiiniseadme pakend. Osa 5: Poorsest materjalist ning plastkilest valmistatud sulgurpaunad ja rullribad. Nõuded ja katsemeetodid
Uusim versioon Kehtiv alates 03.01.2019