ISO 17351:2013 pdf free
ISO 17351:2013 pdf free.Packaging一Braille on packaging for medicinal products
The Braille text shall enable Braille readers to identify the medicinal product.
Compliance with the Braille cell dot height limits (see 4.2) is evidence of compliance with the text legibility requirement.
If the MAH does not specify compliance with the Braille cell dot height requirements (see 4.2 and A.1) then legibility testing shall be carried out in accordance with A.2.
In order to ensure that Braille readers can identify the medicinal product, the Braille cell dot height of production samples when measured in accordance with A.1 at the packaging e.g. carton or label) manufacturer’s site shall be:
a) for, embossed materials the target Braille cell dot height shall be 0,20 mm with not more than 5 % of Braille cell dot height measurements lower than 0,12 mm and not more than 1 % of Braille cell dot height measurements lower than 0,10 mm;
b) forother Braille production methods, e.g. screen-printed labels, the target Braille cell dot height shall be 0,20 mm, with not more than 5 % of Braille cell dot height measurements lower than 0,16 mm.
NOTE 1The MAH and packaging manufacturer are encouraged to aim for a higher cell dot height in line with the packaging manufacturer’s processes. Cardboard is not an engineering material and considerations relating to Braille cell dot formation contained within Annex C can be taken into account in order to achieve Braille cell dot height requirements.
NOTE 2 Burst-through can occur when the substrate or any surface coating fractures, causing damage to print and/or surface finish. Burst-through is not recommended, but might be accepted by certain markets, however the presence of burst-through should not in itself constitute a valid reason for batch rejection.
NOTE 3 Braille dots should not compromise any printed text, whether the dots are intact or are formed with a burst-through.
NOTE 4 The Braille cell dot height limits included above reflect technical issues associated with the production of pharmaceutical packaging – they do not necessarily represent a Braille cell dot height that can be achieved with other media.
Braille shall not be obscured by labels or any other adhesive devices, with only one exception: where Braille needs to be altered, the new Braille text should cause the original Braille text to be totally obscured.ISO 17351 pdf download.
