BS EN ISO 15223-1:2016 - Tracked Changes

BS EN ISO 15223-1:2016 - TC

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

Status : Current   Published : February 2019


What is a tracked changes standard? 

A tracked changes version of a Standard indicates the changes made, during the standards revision process, between the active standard and its previous version. Additions, deletions, and other formatting and/or content revisions are clearly displayed as underlined and strikethrough texts, ensuring all changes made between the two documents are quickly and easily identified. This version of the standard includes both a copy of the new standard, along with a track changes version.

What is this standard about?

Many countries want information displayed on medical devices to be in their own language, but this can be problematic: multiple languages can cause confusion and delays as well as problems with translation, design and logistics. More variables can add costs for manufacturers. To help, this standard provides internationally recognized symbols with precisely defined descriptions that can appear on the device itself, as part of the label, or can be provided with the device.

Who is this 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

Why should you use this standard? 

It 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.

What’s changed since the last update?

The 2012 standard was systematically reviewed by technical experts to ensure its continued market relevance. In this 2016 version, none of the symbols have been changed but some of the requirements have been updated.

Standard NumberBS EN ISO 15223-1:2016 - TC
TitleTracked Changes. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
Publication Date01 February 2019
Normative References(Required to achieve compliance to this standard)ISO 15223-2, ISO 8601, ISO 7000
Informative References(Provided for Information)ISO 18113-5, ISO 18113-3, ISO 18113-1, IEC 60417, ISO 7010, IEC 80416-1, N43:2005, ISO 14971, ISO 18113-4, ISO 3864-1, ISO 18113-2, EN 1041, 93/42/EEC, 98/79/EC, IEC 80416-3:2002, EN 556-1:2001, 90/385/EEC
DescriptorsSymbols, Identification methods, Labelling (process), Graphic symbols, Medical equipment
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
ISBN978 0 539 03826 2
File Size5.516 MB

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