International Organization for Standardization (ISO)
Latest
ISO 8536-12:2021
Scope
This document 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 this document also apply to inline check valves.
ISO 8536-12:2021 Referenced Document
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 7886-1 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8536-4 Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
ISO 8871-2 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization
ISO 8536-12:2021 history
2021ISO 8536-12:2021 Infusion equipment for medical use - Part 12: Check valves for single use