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Labeling/Marking Location for BF Symbol

Q

QM Becky

#1
#1
Hi Everyone, Hoping for a bit of guidance on the use of the BF symbol for on product identification.

We have a product in development that will require BF marking. During a review yesterday it became apparent that the location requirement for the on product marking may be difficult to achieve given the configuration of the device and an associated cover (think cell phone case).

Is the BF symbol REQUIRED to be located next to the connection point, or is it acceptable to be on the device in a visible location?

Appreciate any insight or guidance you all can provide.
 
QMS for Medical Device Companies
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P

Pads38

Moderator
#2
#2
Clause 7.2.10 (of 60601-1 Ed 3.1)
...all APPLIED PARTS shall be marked with the relevant symbol,

The relevant symbol shall be marked adjacent to or on the connector for the APPLIED PART unless either:
...no connector, in which case... shall be on the APPLIED PART; or
- the connector is used for more than one AP with different classifications.

Clause 7.2.1 Minimum Requirements for marking
If the size...does not allow affixation of all markings...then at least the markings...7.2.10

Where no marking...is practicable...may be affixed to...packaging.

From all that I would suggest that a BF symbol adjacent to the relevant connector has to be 'high priority' - even if it means leaving of other symbols / information (eg IP rating - 7.2.9).
 
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