BAS EN ISO 15223-1:2018
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
General Information
Status: Withdrawn
No. of pages: 36
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 29.08.2018
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices;
93/42/EEC, Medical devices
98/79/EC, In vitro diagnostic medical devices;
93/42/EEC, Medical devices
98/79/EC, In vitro diagnostic medical devices;
...
Abstract
ISO 15223-1:2016 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.
ISO 15223-1:2016 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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 15223-1:2016, identical
- ISO 15223-1:2016, identical