What is BS EN ISO 15223‑1 - Medical devices information symbols about?
It is vital for that the information provided on medical devices is correctly understood by every player in the supply chain.
BS EN ISO 15223‑1 is the first part of a series of international standards that specifies which symbols should be used to express information supplied for a medical device - both on their packaging and within accompanying information.
Its requirements are applicable to symbols used in a broad spectrum of medical devices that are available globally and need to meet different regulatory requirements.
NOTE: The requirements in BS ISO 15223-1 are not intended to apply to symbols specified in other standards.
What are the benefits of using BS EN ISO 15223‑1 - Medical devices information symbols?
Medical device manufacturers and others in the supply chain must provide specific medical device information that’s essential to the safe and proper use of the medical device. Symbols can be used to convey that information without the need to translate text into multiple languages. BS EN ISO 15223-1 provides internationally recognized symbols for this purpose.
By implementing its principles and guidelines in your organization, your business can benefit from:
- Ensuring effective use of your medical devices and patient safety
- Saving significant costs and labelling space – either from costly translations or labelling changes
- Complying with various regulatory requirements
- Ensuring consistency and eliminating any ambiguities when portraying information
- Improved consumer understanding and informed product choices
Who is BS EN ISO 15223‑1 - Medical devices information symbols for?
BS EN ISO 15223‑1 is relevant to anyone who manufactures medical devices – no matter the size of the organization - or works within the supply chain. For some, using this standard might be a regulatory requirement.
Other who might use BS EN ISO 15223‑1 include:
- Healthcare professionals and institutions
- Distributors of medical devices or other representatives of manufacturers
- Healthcare providers responsible for training, as well as those being trained
- Healthcare regulatory authorities, testing organizations and certification bodies
What’s changed since the last update?
BS EN ISO 15223‑1:2021 supersedes BS EN ISO 15223‑1:2016, which is withdrawn. BS EN ISO 15223‑1:2021 includes some technical changes with respect to BS EN ISO 15223‑1:2016. These include:
- Addition of 20 symbols that were validated as per BS ISO 15223‑2.
- Addition of 5 symbols previously published in BS 70000, BS ISO 7001 and IEC 60417.
- Deletion of the defined term “labelling”.
- Inclusion of defined terms from BS EN ISO 20417, BS EN ISO 13485 and BS EN ISO 14971.
- Information about European regulations has been moved to informative notes throughout