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ISO 15223-1:2016

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements (Corrected version 2017-03)

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Kehtetu alates 06.07.2021
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06.07.2021
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02.11.2016
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ISO 15223-1:2012
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.
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ISO 15223-2:2010

Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation
Uusim versioon Kehtiv alates 15.01.2010
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ISO 13485:2016

Medical devices -- Quality management systems -- Requirements for regulatory purposes
Uusim versioon Kehtiv alates 25.02.2016
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ISO 14971:2019

Medical devices -- Application of risk management to medical devices
Uusim versioon Kehtiv alates 10.12.2019
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EVS-EN ISO 14971:2012

Meditsiiniseadmed. Riskijuhtimise rakendamine meditsiiniseadmetele
Kehtetu alates 02.01.2020