BS EN ISO 15223-1:2016 pdf free.Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part1:General requirements.
This document addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required to appear with the medical device in most regulatory domains. The information can be required to appear on the medical device itself, as part of the label, or provided with the medical device.
Many countries require that their own language be used to display textual information with medical devices. At the same time, manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This can cause problems in relation to translation, design and logistics when multiple languages are included on a single label or piece of documentation. For example, users of medical devices labelled in a number of different languages can experience confusion and delay in locating the appropriate language.
BS EN ISO 15223-1 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined descriptions.
While compiling symbols to be included in this document, ISO/TC 210 recognized the need for systematic methodology for the selection, development and validation of symbols proposed for adoption. This is the subject of ISO 15223-2.
This document is primarily intended to be used by manufacturers of medical devices 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, and
— consumers or end users of medical devices who draw their supplies from a number of sources and can have varied language capabilities.
BS EN ISO 15223-1 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.
This document is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 70001), Graphical symbols for use on equipment — Registered symbols
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation