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New Work Item Proposal - Respiratory infection prevention devices for self- and third-party protection - Part 3: Sustainability, human factors and rationales

Source:
CEN
Committee:
CH/205 - Non-active medical devices
Categories:
Information management | Standardization. General rules
Comment period start date:
Comment period end date:

Comment by:

Scope

This document provides guidance on sustainability and human factors in regard of respiratory infection prevention devices (RIPDs). In addition it provides some rationales for the requirements which are given in EN 18178-1.

RIPDs are intended to reduce the emission of infective agents from the user’s airways into the environment and also reduce exposure to the user from inhalation of infective agents. RIPDs are intended for use by the population.

Purpose

Pandemic situations require the government to have a potential tool in the form of a standard for respiratory infection prevention devices (RIPDs) to protect all strata of the population. With the standard series, manufacturers receive a reference document for comparing their products with the specified requirements and test conditions. With the RIPD the end consumer receives a product with which he can protect his health.

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