Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
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BS EN ISO 15223-1:2016

Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements

Status : Current   Published : December 2016

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BS EN ISO 15223-1:2016 - Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied. General requirements

Many countries require that the information displayed on medical devices is in their own language, yet multiple languages can cause confusion and delay in locating the right version. As well, multiple languages can cause problems with translation, design and logistics. Finally, manufacturers may also want to take costs out of labelling by reducing the variants.

To help with all three issues, BS EN ISO 1522-1 supplies internationally recognized symbols with precisely defined descriptions that can appear on the medical device itself, as part of the label or be provided with the device.

Who is the standard for?

This standard is targeted at medical devices manufacturers and in vitro diagnostic product manufacturers. It is particularly relevant to manufacturers who market identical products in countries where there are different language requirements for medical device labelling.

It can also be of assistance to:

  • Distributors of medical devices or other representatives of manufacturers
  • Healthcare providers responsible for training, as well as those being trained
  • Those responsible for post-market vigilance
  • Healthcare regulatory authorities, testing organizations, certification bodies and other organizations which are responsible for implementing regulations affecting medical devices and which have responsibility for post-market surveillance
  • Consumers or end-users of medical devices who draw their supplies from a number of sources and can have varied language capabilities

What does the standard cover?

The standard lists symbols to be used with medical device labels, labelling and information to be supplied. The standard also identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.

The symbols are used in a broad spectrum of medical devices which are marketed globally and therefore need to meet different regulatory requirements.

The standard is relevant to all medical device markets. It is also provides symbols for the in vitro diagnostic market.

Note: It is intended for this standard to be harmonized to the medical device directives.

How is the 2016 standard different from the 2012 version?

None of the symbols have been changed in this revision, only some the requirements. 




Standard NumberBS EN ISO 15223-1:2016
TitleMedical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
StatusCurrent
Publication Date31 December 2016
Cross ReferencesISO 7000, ISO 8601, ISO 15223-2, 93/42/EEC, 90/385/EEC, 98/79/EC, ISO 3864-1, ISO 7010, ISO 14971, ISO 18113-1, ISO 18113-2, ISO 18113-3, ISO 18113-4, ISO 18113-5, IEC 60417, IEC 80416-1, IEC 80416-3:2002, EN 556-1:2001, EN 1041, GHTF/SG1/N43:2005
ReplacesBS EN ISO 15223-1:2012
Amended ByCorrigendum, March 2017
DescriptorsSymbols, Identification methods, Medical equipment, Graphic symbols, Labelling (process)
ICS01.080.20
11.040.01
Title in FrenchDispositifs médicaux. Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux. Exigences générales
Title in GermanMedizinprodukte. Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen. Allgemeine Anforderungen
CommitteeCH/210/3
ISBN978 0 580 98047 3
PublisherBSI
FormatA4
DeliveryYes
Pages44
File Size2.239 MB
Price£190.00


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