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?
IEC 60601 Medical Electrical Equipment Classifications: FAQ’s