BSI has published a new international standard to promote global consistency and help drive innovation in the labelling of medical devices.
BS EN ISO 15223-1 - Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements - promotes the use of internationally recognized symbols with precisely defined descriptions. The new international standard supersedes the well-respected European standard, BS EN 980:2008, which will consequently be withdrawn on 31 January 2013.
The publication of BS EN ISO 15223-1 is BSI’s response to the medical device industry’s requirement for a globally recognized set of standard symbols, which is considered as essential by the regulatory authorities for the safe and proper use of such instruments. The standard aims to help safeguard public health by assuring the effective and proper labelling in line with an agreed standard. BS EN ISO 15223-1 will also be harmonized under all three EU medical device directives (i.e. Medical Devices, Active Implantable Medical Devices and In-vitro Diagnostic Medical Devices).
Information may be required to appear on the medical device itself, as part of the label, or provided with the medical device. As such this new standard reduces the need for multiple languages to be included on a single label and mitigates potential confusion and delays to those having to select the appropriate language when using the device.
The strength of the new publication lies in the consensus approach to its development which has been driven by an international committee of experts including UK representatives from the Association of British Healthcare Industries, the Association of Anaesthetists of GB & Ireland, the British Anaesthetic & Respiratory Equipment Manufacturers Association, the British Dental Association, the Institute of Physics & Engineering in Medicine, the Medicines and Healthcare products Regulatory Agency, the National Blood Service and the Surgical Dressings Manufacturers Association.
BS EN ISO 15223-1 will be of distinct interest to medical device manufacturers, in particular regulatory professionals, but also designers, production teams and consultants. Other interested parties are likely to include suppliers of safety signs and stickers, technical authors and regulators.
“BSI strives to instil processes, systems and standards to reduce risk and promote industry growth,” said Shirley Bailey-Wood, Director of Publishing at BSI. “The publication of BS EN ISO 15223-1 is further demonstration of BSI’s commitment to embedding a culture of best practice across the medical devices industry. A major focus for the medical devices industry for the future is to improve quality and eliminate accidents and errors. This is where standards become invaluable since they provide a robust framework for consistency and promote a best practice approach to the activities delivered with this field.”
“Countries require their local languages to be used to display information associated with medical devices and this can cause problems relating to translation, design and labelling of products and documentation,” said Andy Vaughan, BSI committee member, CEN/CENELEC Healthcare Sector Rapporteur and ABHI Standards Consultant. “This standard provides manufacturers, distributors, healthcare providers, regulators and consumers with a set of internationally recognized symbols with precise descriptions. It represents a significant advance in the safe and effective use of symbols for medical devices.”
BSI is also due to publish a CD-ROM, in early August 2012 containing each of the symbols in JPEG, TIF and EPS format, which can then be downloaded and reproduced easily by users. The CD-ROM will also contain the standard BS EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates, along with its symbols in JPEG, TIF and EPS formats.
BS EN ISO 15223-1 will be a complementary standard useful to those already using BS EN ISO 13485:2012 - Medical devices. Quality Management Systems. Requirements for regulatory purposes - published earlier this year and BS EN ISO 14971:2012 - Medical devices. Application of risk management to medical devices – the latter which is likely to be published later this month.
For further information about BS EN ISO 15223-1 - Medical devices. Symbols to be used with medical device labels, labeling and information to be supplied. General requirements – and the corresponding CD-ROM, please visit shop.bsigroup.com/