British Standards Institution

Source:: CEN
Committee:: CH/205 - Non-active medical devices
Categories:: Information management | Standardization. General rules | Healthcare | Medical equipment | Anaesthetic, respiratory and reanimation equipment

Scope

This document specifies the minimum functional and performance requirements and test methods for respiratory infection prevention devices (RIPDs).

RIPDs are intended to reduce the emission of infective agents from the user’s airways into the environment, and to reduce the exposure to the user from inhalation of infective agents. RIPDs are intended for use by everybody regardless of age, facial morphology or ability

Purpose

Outbreaks of respiratory infection could require a device that is protective in both breathing directions (outward and inward). In environments relating to the regulation (EU) 2017/745 on Medical Devices (MD) the applicable standard is EN 14683. In environments relating to the regulation (EU) 2016/425 on Personal Protective Equipment (PPE) there is a number of applicable standards (for example EN 149). In environments where the two former EU regulations are not applicable, the General Product Safety Directive (2001/95/EC) (GPSD) applies supported by CEN/TS 17553. This document intends to define requirements for respiratory infection prevention devices that will be regulated under both MD and PPE regulations.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

01/03/2023

Proposal end date:

19/03/2023

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

Draft Dec 7-2023 - AdoptionPWI for RIPD Respiratory infection prevention devices for self- and third-party protection - Requirements and test methods

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