CEN EN ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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European Committee for Standardization
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
N EN ISO 15223-1
Annotation
This document 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.
Автоматический перевод:
Медицинские устройства - Символы, которые будут использоваться с метками медицинского устройства, маркировкой и информацией, которая будет поставляться - Часть 1: Общие требования
Этот документ идентифицирует требования для символов, используемых в медицинском устройстве, маркирующем, которые передают информацию о безопасном и эффективном использовании медицинских устройств. Это также перечисляет символы, которые удовлетворяют требования этого документа.



