Тезис Предпросмотр
NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
Общая информация
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Текущий статус : PublishedДата публикации : 2021-04
Исправленный вариант (английский) : 2021-12
Исправленный вариант (Французский) : 2021-12 -
Версия : 1
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Технический комитет:Quality management and corresponding general aspects for medical devices
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- ICS :
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Medical equipment in general
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Формат | Язык | |
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PDF + ePub | ||
Бумажный |
- CHF178
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