British Standards Institution

Source:: ISO
Committee:: CH/212 - IVDs
Categories:: Transfusion, infusion and injection equipment
Comment period start date:: 28/08/2024
Comment period end date:: 21/10/2024
Number of comments:: 0

Comment by:

21st Oct

Scope

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets used together with the volumetric infusion controllers of IEC 60601-2-24[1].

Note: In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document[3-5].

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

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

21/06/2024

3. Public Comments

Public Comments start date:

28/08/2024

Public Comments end date:

21/10/2024

Learn more about the standards development process

Standards Development

BS EN ISO 8536-16 ISO 8536-16 Infusion equipment for medical use. Part 16: Infusion sets for single use with volumetric infusion controllers

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