Overview

This part of ISO 8536 specifies requirements for accessories for single use in fluid lines and pressure infusion equipment up to a maximum of 200 kPa (2 bar) as specified in ISO 8536-4 to ensure that they are suitable for use with containers for infusion solutions and intravenous puncture devices. This specifies the requirements for sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-4. This equipment contains two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC), stopcocks manifold (SM), units with injection site (UIS), units with check valve (UCV), stoppers (S) and adapters (A). This standard also contains requirements regarding the quality and performance of the materials used for the equipment. The European Standard has been prepared by ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN, Germany), in collaboration with CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany) with the participation of German experts. The responsible national committee is Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und -geräte aus Kunststoffen" ("Transfusion/infusion containers and equipment made from plastics") of the DIN Standards Committee Medicine (NAMed).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices