BS EN ISO 8536-12:2021

What is ISO 8536-12 about?  

ISO 8536-12 is one of a series of documents for infusion equipment for medical use that specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus. 

The functional requirements in ISO 8536-12 also apply to inline check valves. 

Who is ISO 8536-12 for? 

ISO 8536-12 on infusion equipment for medical use is useful for- 

• Manufacturers of check valves for single use 
• Manufacturers of infusion equipment for medical use 
• Medical laboratories 

Why should you use ISO 8536-12? 

Infusion equipment for medical use when supplied by the supplier, there can be changes, leakage or damage in check valves intended for single use, so proper manufacturing and high-quality maintenance is needed. 

ISO 8536-12 helps in the manufacturing high quality infusion equipment intended for medical use by providing general requirements, materials, designation, and labelling for the same which ensures the protection of user's health, safety, and environment. 

What’s changed since the last update? 

BS EN ISO 8536-12:2021 supersedes ISO 8536-12:2021, which has been withdrawn. BS EN ISO 8536-12:2021 has some technical changes with respect to ISO 8536-12:2021, these include: 

• The title of this document has been amended by "for single use" 
• Clause 3 has been completely reviewed, Clause 4, 'Designation' refers now to 'Labelling', and Clause 11 has been added  
• The requirement on tensile strength has been deleted and the connecting requirements have been aligned to the ISO 80369 series 
• Annex A has been completely updated and aligned with the physical requirements given in Clause 6 
• The normative references have been updated and the bibliography has been added 
• Complete editorial review