ISO 23416:2023

недоступно на русском языке

Опубликовано (Версия 1, 2023)

ISO 23416:2023

CHF 96

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Тезис

This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling.

This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.

Общая информация

Текущий статус
: Опубликовано

Дата публикации
: 2023-01

Этап
: Опубликование международного стандарта [60.60]
Версия
: 1
Технический комитет :
ISO/TC 122

ICS :
55.020 11.120.99
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