ISO EN 60601 Edition 3 Class IIa Medical Device Compliance

[Dylansnow]

I am in the process of getting a Class IIa Medical Device through delta testing for compliance to:


ISO 60601-1 2006 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

ISO 60601-2 2007 "Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

I purely want to get a CE Mark and market in Europe.

Q. 1.
In order to get a CE Mark will I also have to get a CB Test Certificate.

Q. 2.
The device was CE Marked a number of year ago (which lapsed)and was tested to this list of standards below - Are these standards still current - they are not listed on the Summary list of titles and references harmonised standards under Directive 93/42/EEC for Medical devices

EN 55011: 1998 +A1: 1999 Limits and methods of measurement of radio disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment [CISPR 11: 1997 + A1: 1999]
EN 61000-3-2: 1995 + A1: 1998 + A2: 1998 Harmonic current emissions [IEC 61000-3-2: 1995 + A1: 1997 + A2: 1998]
EN 61000-3-3: 1995 Voltage fluctuation and flicker [IEC 61000-3-3: 1994]
EN 61000-4-2: 1995 + A1: 1998 Electrostatic Discharge ESD [IEC 61000-4-2: 1995 + A1: 1998; replaces 801-2: 1991/ IEC 1000-4-2]
EN 61000-4-3: 1996 + A1: 1998 Radiated RF Electromagnetic Field [IEC 61000-4-3: 1995 + A1: 1998; replaces IEC 801-3/ IEC 1000-4-3]
EN 61000-4-4: 1995 Electrical Fast Transient/ Burst [IEC 61000-4-4: 1995; replaces IEC801-4/ IEC 1000-4-4]
EN 61000-4-5: 1995 Surge [IEC 61000-4-5: 1995; replaces IEC 801-5/ IEC 1000-4-5]
EN 61000-4-6: 1996 Conducted RF Field [IEC 61000-4-6: 1996; replaces IEC 801-6/ IEC 1000-4-6]
EN 61000-4-11: 1994 AC Voltage Variations [IEC 61000-4-11: 1994; replaces IEC 1000-4-11]

Regards

Dylan

 

[Stijloor]

A Quick Bump!

Can someone help Dylan?

Thank you very much!!

 

[occounty]

Most of standards have being superseded, you can find the recent edition of standard by searching for standard number and most recent ones generally show up on the top.

You can search for documents that lists the differences/changes in current and previous version of a standard, but is always a good idea to check the compliance withe most recent version of a given standard.

Hope that helps.