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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
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