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

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UL 60601-1 (USA)

Note: In order to more closely align the UL standard number with the IEC standard number, UL published the first edition of UL 60601-1 in April 2003 to replace UL 2601-1.


The following are the main differences between UL 60601-1 and IEC 60601-1. Please note that not all differences are listed here.

You should consult UL 60601-1 for full information.

Components: Certain components must comply with the relevant ANSI/UL standards for those components, e.g. Lithium batteries must comply with UL 1642, fuseholders with UL 512, etc. In general UL will only accept components which have been approved by UL itself, though other NRTL's (National Recognized Testing Laboratories) may have more flexible policies concerning component approvals.

Leakage current: UL 60601-1 has more stringent leakage current requirements than IEC 60601-1

Moving parts: Where moving parts may cause injury, the maximum travel of those part must be limited by end stops or other mechanical means.

Oxygen: There are additional constructional requirements for medical devices that are used with oxygen or oxygen enriched atmospheres.

Conductive coatings: Nonmetallic surfaces of enclosures with conductive coatings generally have to comply with UL 746C. Both the materials and the process used have to be approved by UL.

Flammability: Polymeric enclosures and covers generally have to comply with flammability requirements.

Mains Plug: If  appropriate "Hospital Grade" or "Hospital Only" mains plugs exist for the electrical rating of the medical device, these are used.

Power Supply Cords: UL 60601-1 specifies the power supply cord types that may be used.

Markings: There are various additional markings requirements.

 

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.