ISO 15223-1:2021/Amd 1:2025
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 3
- Дата публикации:
- 3 марта 2025 г.
- Издание:
- ISO IS 15223 edition 4 version 1
- ICS:
- 01.080.20
Abstract
Overview
ISO 15223-1:2021/Amd 1:2025 is an important international amendment to the standard, focusing on medical devices and the symbols used in manufacturer-supplied information. This amendment introduces a defined term for the "authorized representative" and modifies the EC REP symbol to ensure it is not restricted to any specific country or region. Developed by the International Organization for Standardization (ISO), this update supports clear and consistent global communication for medical device information, contributing to enhanced regulatory compliance and user safety.
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