British Standards Institution

Source:: ISO
Committee:: CH/205 - Non-active medical devices
Categories:: Information management | Standardization. General rules | Healthcare | Medical equipment | Medical equipment. General

Scope

This document specifies a test method which is applicable for the assessment on bacterial retention ability of finished air-inlet filters for infusion and transfusion sets as well as transfer devices.

Assessment on bacterial retention ability of air filtration membrane materials for infusion and transfusion sets as well as transfer devices may refer to this document.

Purpose

This project is to apply the Vienna Agreement procedure on the current ISO/CD 24072, Aerosol bacterial retention test method for air-inlet on infusion sets. The intended standard is an important amendment to the standard series ISO 8536, Infusion equipment for medical use. Due to that this ISO series has been completely overtaken as EN ISO standards as well, it is appropriate to apply the VA process as well for ISO/CD 24072.

Comment on proposal

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

Standard timeline

1. Proposal

Proposal start date:

03/08/2021

Proposal end date:

20/08/2021

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

Draft Dec 9/2021 - AdoptNewWI - EN ISO 24072, Aerosol bacterial retention test method for air-inlet on administration devices

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