Need help?

EN 60601-1:2006/A1:2013 Standard

wave
Save  

  Keywords:

#equipment #systems #covered #iec #iso

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

  Purpose

Other names: IEC 60601-1:2005/A1:2012 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 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. NOTE 1 See also 4.2. The IEC 60601 series does not apply to: – in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61]; – implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or – medical gas pipeline systems covered by ISO 7396-1 [68]. NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 60601-1:2006"

  Reference

This standard supersedes the "EN 60601-1:2006/AC:2010"

Anyway is still possible use the "EN 60601-1:2006/AC:2010" until December 31st, 2017

  Related Standards

EN 62083:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systemsIEC 62083:2009

EN ISO 5360:2009

Medical devices Directive (93/42/EEC)

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)

EN 1707:1996

Medical devices Directive (93/42/EEC)

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings

EN 1865-3:2012

Medical devices Directive (93/42/EEC)

Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

EN 1865-4:2012

Medical devices Directive (93/42/EEC)

Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair

EN 1865-5:2012

Medical devices Directive (93/42/EEC)

Patient handling equipment used in road ambulances - Part 5: Stretcher support

  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 60601-1:2006/A1:2013 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