Need help?

EN 60601-1-6:2010 Standard

wave
Save  

  Keywords:

#use #usability #associated #risks #equipment

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityIEC 60601-1-6:2010

  Purpose

This International Standard 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, hereafter referred to as ME 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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 60601-1-6:2007"

Anyway is still possible use the "EN 60601-1-6:2007" until April 1st, 2013

  Related Standards

EN ISO 13408-2:2018

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

EN ISO 22442-3:2007

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viru...

EN 27740:1992/A1:1997

Medical devices Directive (93/42/EEC)

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN 27740:1992

Medical devices Directive (93/42/EEC)

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN ISO 26782:2009/AC:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 267...

EN ISO 26782:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 267...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 60601-1-6:2010 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0