ISO 8536-12:2021
Infusion equipment for medical use - Part 12: Check valves for single use

Standard No.
ISO 8536-12:2021
Release Date
2021
Published By
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

Infusion equipment for medical use - Part 12: Check valves for single use



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