BSI have published the BS EN ISO 15223-1:2021, Medical devices - Symbols to be used with information to be supplied by the manufacturer.The difference between this version and ISO 15223-1:2021 is the inclusion of the European Foreword and Annexes ZA & ZB (showing the relationship between the standard and the MDR/IVDR) and the new National Foreword specifically for the UK. No GB National Annex Zs have been created yet but we would expect these to be prepared in the future, such as was done for BS EN ISO 13485:2016+A11.
NOTE: There are no differences to the content of the standard or design & meaning of the symbols in the ISO, EN or BE EN versions of the standards. The differences are:
- ISO version - no European or National Forewords, no Annex Zs
- EN ISO version - includes the European Foreword and Annexes ZA & ZB
- BS EN ISO version - includes the UK National Foreword in addition to the the European Foreword and Annexes ZA & ZB
The standard can be purchased at https://shop.bsigroup.com/products/medical-devices-symbols-to-be-used-with-information-to-be-supplied-by-the-manufacturer-general-requirements
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Lena Cordie-Bancroft
Leicester
UK
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