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presentations, medical device standards and regulations, iec 60601 - medical electrical equipment
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  #1  
Old 17th February 2011, 06:42 PM
qremsg26 qremsg26 is offline
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Please Help! IEC 60601 Presentation
Hi All, I am new in QA and Regulatory and I need to prepare a presentation on IEC 60601. I am just reading online material for the input and found this site. Can you please provide me valuable information for my presentation?

I work in a Medical device industry (dialysis chairs, dialysis equipment etc). And I am completely illeterate about IEC standards.

Thanks in advance.
SG
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Old 17th February 2011, 08:30 PM
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Re: IEC 60601 presentation
Who is your presentation targeted to?
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Old 18th February 2011, 12:09 AM
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Re: IEC 60601 presentation
Introduce IEC 60601 Standards, compare 2nd and 3rd editions, Requirements for 3rd edition to comply. What does IEC standards mean to a medical device industry.
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Old 18th February 2011, 03:43 AM
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Lurker Re: IEC 60601 Presentation
Quote:
In Reply to Parent Post by qremsg26 View Post

Hi All, I am new in QA and Regulatory and I need to prepare a presentation on IEC 60601. I am just reading online material for the input and found this site. Can you please provide me valuable information for my presentation?

I work in a Medical device industry (dialysis chairs, dialysis equipment etc). And I am completely illeterate about IEC standards.

Thanks in advance.
SG
Try this as a start:

http://www.intertek.com/medical/iec-60601-1-paper/

Steve
Thanks to SteveK for your informative Post and/or Attachment!
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Old 21st February 2011, 05:53 PM
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Re: IEC 60601 Presentation
Hi Steve,

Thanks for the information.
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Old 2nd March 2011, 02:52 PM
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Look! Re: IEC 60601 Presentation
The UL 60601 web page has links to the following which may help under "Additional Resources": http://www.ul.com/global/eng/pages/o...vices/ul60601/
  1. Article written in 2006 on the changes to the 3rd edition.
  2. Q&A on the 3rd edition, which includes answers to questions customers have asked on 3rd edition requirements, including CB Scheme, software, risk management, power supplies, etc.
In addition, the UL University Thought Leadership pages have these papers available for download:
1. Home Healthcare Equipment: An Overview http://www.uluniversity.us/common/lmsform.aspx?Form=WhitePaperAccount&Doc=Home_Healthcare_Whitepaper.pdf&CID=73

2. Part 1- A review of market entry requirements for Risk Management, with Special Emphasis on FDA and ISO 14971 Compliance http://www.uluniversity.us/common/lmsform.aspx?Form=WhitePaperAccount&Doc=WP_Risk_Management.pdf&CID=73

3. Part 2- A review of market entry requirements for Risk Management, with Special Emphasis on FDA and ISO 14971 Compliance http://www.uluniversity.us/common/lmsform.aspx?Form=WhitePaperAccount&Doc=WP_Risk_Management_Part2.pdf&CID=73

4. Major Regulatory Decisions on the Third Edition of IEC 60601-1 (The 3rd Edition Update: 2010) http://www.uluniversity.us/common/lmsform.aspx?Form=WhitePaperAccount&Doc=White_Paper_3rd_Edition.pdf&CID=73
I hope that helps.
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