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The Medical Device Developer's Guide to IEC 60601-1

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Applied Part: Type B, BF or CF

 

IEC 60601-1 uses the term applied part to refer to the part of the medical device which come into physical contact with the patient in order for the device to carry out its intended function.

Applied parts are classified as Type B, Type BF or Type CF according to the nature of the device and the type of contact. Each classification has differing requirements from the point of view of protection against electrical shock.

Type CF is the most stringent classification, being required for those applications where the applied part is in direct conductive contact with the heart or other applications as considered necessary.

Type BF is less stringent than CF, and is generally for devices that have conductive contact with the patient, or having medium or long term contact with the patient.

Type B is the least stringent classification, and is used for applied parts that are generally not conductive and can be immediately released from the patient.

Type B applied parts may be connected to earth, while Type BF and CF are 'floating' and must be separated from earth.

Although IEC 60601-1 doesn't stipulate which classification is to be used for specific devices, the particular standards, IEC 60601-2-XX, generally do specify which classification is required.

More details of electrical requirements for applied parts are provided by the articles on circuit separation and leakage currents.

 

The IEC 60601 family of standards

UL 60601-1

Type B, Type BF, or Type CF?

The PC as a medical device

Isolation Transformer

EMC for medical devices

Components and Approvals

Submitting a Product for Testing

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The author thanks the International Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard . All extracts are copyright IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC, its publications and its role is available from www.iec.ch. IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced material referenced due to its placement and context in this publication.  The material is reproduced or rewritten with their permission.