Skip to main content
Back

EVS-EN IEC 80601-2-60:2020

Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

General information

Valid from 15.04.2020
Base Documents
IEC 80601-2-60:2019; EN IEC 80601-2-60:2020
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.04.2020
Main
08.06.2015
Main
IEC 80601-2-60:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE OF DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES AND DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
IEC 80601-2-60:2019 cancels and replaces the first edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

Required fields are indicated with *

*
*
*
PDF
26.84 € incl tax
Paper
26.84 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main + amendment

EVS-EN 62366-1:2015+A1:2020

Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + IEC 62366-1:2015/A1:2020)
Newest version Valid from 17.08.2020
Main

EVS-EN ISO 10993-1:2020

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Newest version Valid from 31.12.2020
Main

EVS-EN ISO 17664-1:2021

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
Newest version Valid from 16.09.2021
Main + amendment

EVS-EN ISO 14971:2019+A11:2021

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Newest version Valid from 15.12.2021