Need help?

EN 60601-1-1:2001 Standard

wave
Save  

  Keywords:

#requirements #electrical #pes #programmable #electronic

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systemsIEC 60601-1-1:2000

  Purpose

This Particular Standard specifies requirements for the safety of gamma beam therapy equipment intended for radiotherapy in human medical practice and includes equipment in which the selection and display of operating parameters can be controlled by a programmable electronic system (PES).

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 60601-1-1:1993 + A1:1996"

Anyway is still possible use the "EN 60601-1-1:1993 + A1:1996" until November 1st, 2003

  Related Standards

EN 1782:1998+A1:2009

Medical devices Directive (93/42/EEC)

Tracheal tubes and connectors

EN 60601-2-43:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment fo...

EN 61676:2002

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiol...

EN 60645-4:1995

Medical devices Directive (93/42/EEC)

Audiometers - Part 4: Equipment for extended high-frequency audiometryIEC 60645-4:1994

EN 60645-2:1997

Medical devices Directive (93/42/EEC)

Audiometers - Part 2: Equipment for speech audiometryIEC 60645-2:1993

EN 60645-1:2001

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometersIEC 60645-1:2001

  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 60601-1-1:2001 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