This part of ISO 8536 applies to sterilized check valves intended for single use and used with infusion
equipment for gravity-feed infusion and/or with pressure infusion apparatus.
NOTE The functional requirements in this part of ISO 8536 also apply to built-in check valves.
ISO 8536-12:2007 Referenced Document
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*, 2018-08-01 Update
ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 31-3 Quantities and units - Part 3: Mechanics; Amendment 1
ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 8536-4:2004 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*, 2020-05-14 Update
ISO 8536-12:2007 history
2021ISO 8536-12:2021 Infusion equipment for medical use - Part 12: Check valves for single use