Electrical Class (Class I, II & III) vs. Medical Device CE marking Class I, II & III

L

LuckyK

#1
I maybe posting a stupid question, but I wanted to know if there is a difference between the Electrical Class (Class I, II & III) and Medical Device CE marking Class I, II & III.
 
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SteveK

Trusted Information Resource
#2
Re: is there a difference

Quick reply - totally different definitions under the meaning of Class.

Steve
 
#3
Re: is there a difference

The classification system for both electrical and mechanical medical devices is the same and no questions are stupid. :)
 

SteveK

Trusted Information Resource
#4
Re: Electrical Class (Class I, II & III) vs. Medical Device CE marking Class I, II &

Much longer answer:

From IEC 60601-1

CLASS I refers to electrical equipment in which protection against electric shock does not rely on BASIC INSULATION only, but which includes an additional safety precaution in that means are provided for ACCESSIBLE PARTS of metal or internal parts of metal to be PROTECTIVELY EARTHED.

CLASS II refers to electrical equipment in which protection against electric shock does not rely on BASIC INSULATION only, but in which additional safety precautions such as DOUBLE INSULATION or REINFORCED INSULATION are provided, there being no provision for protective earthing or reliance upon installation conditions.

CLASS III equipment is used in some other standards (other than IEC 60601-1) to identify equipment that is powered from a safety extra-low voltage (SELV) mains supply system.

MDD 93/42/EEC

Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX.

Examples (parts):

Rule 1
All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies.

Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa.

Rule 9
All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb.

Rule 13
All devices incorporating, as an integral part, a human blood derivative are in Class III.

Steve
 
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