ISO identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices . Partie 1: Exigences générales. STANDARD. ISO. Permission can be requested from either ISO at the address below or ISO’s. ISO Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements.
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For years, medical device manufacturers have had to take two approaches to labelling.
In the US, FDA have insisted that symbols are accompanied by words to describe their meaning, whereas most of the rest of the world has been happy to use symbols alone.
This means US labels are necessarily more complex, and some would argue, less effective.
The insistence on wording was argued to be required in order to avoid doubt as to the meaning of the symbol. All this is about to change as 155223-1 finally embraces the use of stand alone standardised symbols.
If all goes to plan the rule will be come effective in 90 days — on 13 September, The primary effect of the change is to allow a manufacturer to use standardised symbols in place of text on product labelling.
FDA is introducing a change to its recognised standards list See list below to endorse the international izo devices labelling standard ISO as well as several product specific labelling standards covering pacemakers, electrical equipment generally and symbols relating to MRI safety. Cruciallly FDA goes further than this.
EN ISO 15223-1:2016
ASTM F Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. Manufacturers will still have to explain the symbols.
However the explanations no longer have to appear on labelling next to the symbol. Instead, the explanations may now be provided in a separate glossary of symbols, provided either printed glossary in the user manual or as a separate leaflet with the device or as frwe electronic glossary — which could mot 1523-1 be maintained by publication on a web page with a link printed on the labelling.
This is really a catch up for the rest of devices. FDA has made it clear that frew can continue as usual with currently valid labelling, words and all.
Come 13 September, manufacturers bringing forward new regulatory submissions can prepare draft labelling using symbols only as per the new rule. Click here for the full FDA recognised standards database. Need help developing product labelling or FDA or other regulatory submissions.
We take a global approach to regulatory compliance and have a track record of successful support to manufacturers and developers to obtain regulatory approvals in the USA, Europe and the Asia Pacific.
Contact us to discuss how we can help you. This is no symbolic gesture.
EN ISO – Medical devices – Symbols to be used with medical device lab –
FDA Final Rule on device label symbols. Jun 16, admin.
On Extraction — the vagaries Dec 20, TC Wrap Up Dec 13,