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

ISO 8536-12:2021 pdf – Infusion equipment for medical use — Part 12: Check valves for single use.
1 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. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 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 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 medical device labels, labelling and information to be supplied — Part 1: General requirements ISO 80369 (all parts), Small-bore connectors for liquids and gases in healthcare applications 3? Terms? and? definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https:// www .iso .org/ obp — IEC Electropedia: available at http:// www .electropedia .org/
3.3 inline check valve check valve (3.2) that is a built-in feature of the infusion set 3.4 flow? rate rate of flow through an open check valve (3.2) in the flow direction 3.5 backflow? leak? rate rate of counterflow through a closed check valve (3.2) 3.6 opening pressure pressure to open the check valve (3.2) in flow direction 3.7 anti-siphon valve check valve (3.2) that requires an opening pressure (3.6) higher than 2 kPa to open the check valve in flow direction 4 Designation Designation shall follow label requirements in accordance with Clause 9. 5 Materials The materials used shall be chosen so that the check valves conform with the requirements specified in Clauses 6, 7 and 8. If rubber is used as a material, the requirements given in ISO 8871-1 and ISO 8871-2 shall apply. 6 Physical requirements 6.1 Particulate contamination The check valve shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in ISO 8536-4 the number of particles shall not exceed the contamination index limit. 6.2 Leakage The check valve, when tested in accordance with Clause A.2, shall show no signs of air leakage. 6.3 ISO 80369 (all parts) compatibility Any inlet and/or outlet without a tube bond port shall have a connector as specified in the ISO 80369 series. 6.4? Counterflow? pressure? resistance The check valve shall withstand a pressure of 200 kPa in the counterflow direction when tested in accordance with Clause A.3.
9.2 Label on unit container The unit container shall be labelled at least with the following information: a) the name and address of the manufacturer; b) a description of the contents; c) indication that the check valve is free from pyrogens, or that the check valve is free from bacterial endotoxins; d) indication that the check valve is sterile, using the graphical symbol as given in ISO 15223-1; e) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol as given in ISO 15223-1; f) year and month of expiry, accompanied by appropriate wording or the graphical symbol as given in ISO 15223-1; g) indication that the check valve is for single use only, or equivalent wording, or using the graphical symbol as given in ISO 15223-1; h) instructions for use, including warnings, e.g. about detached protective caps (instructions for use may also take the form of an insert); i) the letter “P”, which stands for pressure, or the letter “G”, which stands for gravity, and whose type height shall stand out clearly from surrounding text. If the available space is too small to give all this information in legible characters and/or symbols, the information may be reduced to e) and f). In this case the information as required in this sub-clause shall be given on the label of the next bigger shelf or multi-unit container. 9.3 Label on shelf or multi-unit container The shelf or multi-unit container shall be labelled at least with the following information: a) the name and address of the manufacturer; b) a description of the contents; c) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol as given in ISO 15223-1; d) year and month of expiry, accompanied by appropriate wording or the graphical symbol as given in ISO 15223-1; e) the letter “P”, which stands for pressure, or the letter “G”, which stands for gravity and whose type height shall stand out clearly from surrounding text; f) a storage note, if any.