Applied Parts – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Fri, 31 Jan 2014 20:07:53 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Applied Parts – Eisner Safety Consultants https://eisnersafety.com 32 32 IEC 60601-1 PATIENT APPLIED PARTS of MEE – Notes 1, 2, & 3 – Part 2 of 2 https://eisnersafety.com/2014/01/31/iec-60601-1-patient-applied-parts-of-mee-notes-1-2-3-part-2-of-2/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-patient-applied-parts-of-mee-notes-1-2-3-part-2-of-2 Fri, 31 Jan 2014 20:07:53 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=3604 In this blog, we continue our discussion on Patient Applied Parts, in Part 2, by explaining the 3 notes associated with the definition of Applied Parts, 3.8 of IEC 60601-1, 3rd ed & ed. 3.1.  We use several figures to explain these critical concepts.

If you need help with the IEC 60601 series of Standards, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

]]> IEC 60601-1 Definition of Patient Applied Parts – Part 1 of 2 https://eisnersafety.com/2013/12/20/iec-60601-1-definition-of-patient-applied-parts-part-1-of-2/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-definition-of-patient-applied-parts-part-1-of-2 Fri, 20 Dec 2013 01:11:00 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=3582 This blog will you understand the definition of Patient Applied Parts for medical electrical equipment under the IEC 60601-1 Standard. 

This blog discusses the following points:

  • Definition of APPLIED PART
  • Examples of APPLIED PARTS for specific medical devices
  • Examples of different types of APPLIED PARTS (Type B, BF, CF or & each can be Defibrillator Proof for a total of 6 APPLIED PARTS classifications)
  • 3 Notes in regard to the Definition of APPLIED PART
If you need help with the IEC 60601 series of Standards, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).
]]> IEC 60601 Medical Electrical Equipment Classifications: FAQ’s https://eisnersafety.com/2013/10/26/iec-60601-medical-electrical-equipment-classifications-faqs/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-medical-electrical-equipment-classifications-faqs Sat, 26 Oct 2013 21:46:58 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=3512 IEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog. 

Why do I need to classify my product for IEC 60601-1, 3rd ed.? – The standard says you have to classify“…ME EQUIPMENT, or parts thereof, including applied parts…” as noted in sub-clause 6.1 of IEC 60601-1, 3rd ed or 3rd ed. with Amendment 1 of the standard.. But a more practical reason you would want to classify your products that fall under the scope of IEC 60601-1 (http://bit.ly/60601scope) is it is a helpful tool in identifying the requirements that apply to the device, and helps us in determining the test plan for the product to be tested.

This blog discusses the following FAQ’s:

  • What are the various classifications that are used in IEC 60601-1, edition 3.1?
  • What is an applied part? 
  • What are the classifications for Protection Against Electric Shock? 
  • Power Sources – External Class I, External Class II or Internal
  • Applied Parts – B, BF, CF (also defibrillation-proof)
  • Why do we have classifications for protection against electric shock?
  • What are the classifications for protection against harmful ingress of water or particulate matter?
  • Why do we have classifications for protection against harmful ingress of water or particulate matter?
  • What are the classifications for methods of sterilization?
  • Why do we have classification for the suitability in an oxygen rich environment?
  • What are the classifications for modes of operation?
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