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

1Key Takeaways

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 t…

2Scope / Description

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.

3Version History

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6Frequently Asked Questions

What is EVS-EN IEC 80601-2-60:2020?
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 is an international standard developed by Estonian Centre for Standardisation. 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...
What does EVS-EN IEC 80601-2-60:2020 cover?
This standard covers: 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...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in the medical device and healthcare industry. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
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