The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

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

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
ce mark and ce marking, differences (general), medical devices
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 6th January 2015, 11:43 AM
LuckyK

 
 
Total Posts: n/a
Question Electrical Class (Class I, II & III) vs. Medical Device CE marking Class I, II & III

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.

Sponsored Links
  Post Number #2  
Old 6th January 2015, 12:18 PM
SteveK's Avatar
SteveK

 
 
Total Posts: 788
Lurker Re: is there a difference

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

Steve
  Post Number #3  
Old 6th January 2015, 12:28 PM
J0anne

 
 
Total Posts: 439
Re: is there a difference

The classification system for both electrical and mechanical medical devices is the same and no questions are stupid.
  Post Number #4  
Old 6th January 2015, 12:43 PM
SteveK's Avatar
SteveK

 
 
Total Posts: 788
Lurker 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
Thanks to SteveK for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Medical Device that is class II electrical and IEC 60601-1-11 JoCam EU Medical Device Regulations 5 29th March 2018 03:27 AM
Class I and Class II Medical Device Accessory Design Control Requirements Donabhamra US Food and Drug Administration (FDA) 3 20th March 2013 10:05 PM
Medical Device PACS (Picture Archiving and Communication) - Class I or Class IIa? tebusse EU Medical Device Regulations 2 11th July 2012 08:00 AM
Change Medical Device Class from Class II to Class I AJayC 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8 2nd December 2011 04:39 PM
Percentage of Class I Medical Devices in market - viz Class I, Class II and Class III Ajit Basrur ISO 13485:2016 - Medical Device Quality Management Systems 8 25th February 2008 04:44 AM



The time now is 11:03 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"