This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”).
This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.
Related directives
Directives related to this standards.
2017/745
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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