1. Start

Standard Swedish standard · SS-EN 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Status: Valid

· Corrected by: SS-EN 60601-1 C 1 , SS-EN 60601-1 AC 1 Amended by: SS-EN 60601-1 A 1 , SS-EN 60601-1 A 12 , SS-EN 60601-1 A 11 , SS-EN 60601-1, utg 2:2006/A2:2022

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

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 thecase, 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.
NOTE See also 4.2.
This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.
In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 3).

Scope
Standarden som faställdes 2006 innehåller även IEC 60601-1 utgåva 3 2005.

Standarden behandlar grundläggande säkerhet och väsentlig prestanda för elektriska utrustningar och system för medicinskt bruk. Den anger allmänna fordringar och kompletteras för flertalet utrustningstyper av någon särskild del 2.
Dessutom finns ett antal tilläggsstandarder för bl. a. radiologisk utrustning och elektromagnetisk kompatibilitet.

Subjects

General (11.040.01)