Valid reasons to omit an "ear-tag" type label on a cable?

[Loekje]

Dear Experts,

Our cables/accesories do not have enough space to attach all required labeling, and for this clause 7.2.4 of IEC-60601-1{ed3.1}(2012) states:

Where no marking of the ACCESSORIES is practicable, these markings may be affixed to the individual packaging.

Depending on which NB auditor I speak to we are or are not obliged to attach a flap-type label to these cables.
We argue through usability engineering that for patient use these flaps may be highly irritating and be in the way of other important information on the medical device. And with Risk Management we argue that the risk of the operator or user cutting off the flap and thereby making all labeling unavailable is unacceptable.

Also the worst auditor I have met argued that if we have room for a company logo then we could also use this space for required labeling.
But we argue that our Risk Management dictates it is paramount that a user can immediately identify an accessory as belonging to our company's device. It is virtually impossible to win a discussion with an auditor like that. Causing yet another non-conformity...

Do any of you experts have NB/FDA rulings on this issue in black and white?

Kind regards,
Loek

 

[somashekar]

Dear Experts,

Our cables/accesories do not have enough space to attach all required labeling, and for this clause 7.2.4 of IEC-60601-1{ed3.1}(2012) states:
Depending on which NB auditor I speak to we are or are not obliged to attach a flap-type label to these cables.
We argue through usability engineering that for patient use these flaps may be highly irritating and be in the way of other important information on the medical device. And with Risk Management we argue that the risk of the operator or user cutting off the flap and thereby making all labeling unavailable is unacceptable.

Also the worst auditor I have met argued that if we have room for a company logo then we could also use this space for required labeling.
But we argue that our Risk Management dictates it is paramount that a user can immediately identify an accessory as belonging to our company's device. It is virtually impossible to win a discussion with an auditor like that. Causing yet another non-conformity...

Do any of you experts have NB/FDA rulings on this issue in black and white?

Kind regards,
Loek

Not so worst auditor because he is certainly talking sense.
Cable part accessories as a medical device is certainly not too small, so as to be impractical for readable marking. There are several other types of miniature Medical devices to which this applies.
Various types of 'ear-tag' label can be incorporated even during the cable moulding process which can be used for necessary regulatory labels or laser marking. This all comes from design application to the requirement.