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

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MARKINGS

Clause 6 of IEC 60601-1 gives a complete list of marking required on the outside of the product. Markings needed depend on the type of power source used by the equipment, the type of equipment (classification), as well as other markings for particular types of equipment. Examples of markings which may be required are:

  • Name of manufacturer or supplier
  • Model number or name
  • Voltage supply or voltage range
  • Nature of supply (e.g. three phase)
  • Supply frequency or frequency range
  • Rated input in amperes or volt-amperes, or watts where the power factor is above 0.9.
  • Classification
  • Symbol for Class II equipment, if relevant
  • IP rating, if relevant for equipment protected against harmful ingress of water
  • A symbol, according to the type of applied part, Type B, Type BF or Type CF, if relevant.
  • For equipment with defibrillation-proof applied parts, the relevant symbol.
  • The type and rating of fuses accessible from the outside of the equipment shall be marked adjacent to the fuse-holder
  • A potential equalization terminal shall be marked with the appropriate symbol.
  • A functional earth terminal shall be marked with the appropriate symbol.

The above list is not complete. Clause 6 of the standard should be read for the full requirements.

External markings are tested for durability by carrying out the following test:

Markings are rubbed by hand without undue pressure, first for 15 seconds with a cloth rag soaked in distilled water, then for 15 seconds with a cloth rag soaked with methylated spirit at ambient temperature and then for 15 seconds with a cloth rag soaked with isopropyl alcohol.

After the test marking shall be clearly legible. Adhesive labels shall not have worked loose or become curled at the edges.

 


 

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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.