Это стандарт пересмотренISO 15223-1:2021
Тезис
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.
Общая информация
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Текущий статус : WithdrawnДата публикации : 2016-11
Исправленный вариант (английский) : 2017-03
Исправленный вариант (Французский) : 2017-03 -
Версия : 3
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Технический комитет:Quality management and corresponding general aspects for medical devices
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- ICS :
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Graphical symbols for use on specific equipment
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Medical equipment in general
Приобретены также другие
ISO 13485:2016
Medical devicesQuality management systemsRequirements for regulatory purposesISO 14971:2019
Medical devicesApplication of risk management to medical devicesISO 14155:2020
Clinical investigation of medical devices for human subjectsGood clinical practice
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