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How to decide which medical device symbols go on label and labeling?

SGquality

Quite Involved in Discussions
#1
This question is always in my mind - the ISO 15223 has so many symbols but how to decide which medical device symbols go on product, product label, primary packaging, and so on?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
This question is always in my mind - the ISO 15223 has so many symbols but how to decide which medical device symbols go on product, product label, primary packaging, and so on?
First, identify what information has to be on/in each of the labelling elements. This is mostly driven by applicable regulatory/statutory and customer requirements.
Then you may consider using symbols - for space considerations, translation avoidance or other reasons.
Last, use applicable standards to identify the correct symbols and use them in a compliant manner.
You don't have to use any symbol unless the regulations explicitly require it.
 
#4
Specific question in regards to single use labeling - is single use labeling required? For example a class 1 medical device that practitioners routinely clean, sterilize, and re-use although the labeling may not specify "single-use only" or "multi-use" Is it acceptable to not make either single use or multiuse claim on label?
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Specific question in regards to single use labeling - is single use labeling required? For example a class 1 medical device that practitioners routinely clean, sterilize, and re-use although the labeling may not specify "single-use only" or "multi-use" Is it acceptable to not make either single use or multiuse claim on label?
If the device requires reprocessing and this is not clearly stated in the labelling it's a safety issue, most likely unacceptable.
 
#6
Adding to what Yodon has mentioned, it's up to the manufacturer to decide how much is enough. The standards for e.g. IEC 60601-1 layout the principles/context of application, some of them depend on the device. Most importantly before asking “how many”, manufacturers should do a risk management of the application as stated in ISO 15223-1. For e.g., if the device is intended for home use then depending on the user profile a symbol may be misunderstood/ignored leading to an adverse event (AE).
 
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