BS EN ISO 15223-1:2021

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.

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.

Others 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

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