ISO 8536-12:2021 pdf download – Infusion equipment for medical use — Part 12: Check valves for single use.
6.5 Flow rate When the check valve is connected to the infusion equipment, the flow rate shall not be less than 6 l/h when tested in accordance with Clause A.4 . 6.6 Blocking performance The check valve shall close at a pressure of not more than 2 kPa in its counterflow direction when tested in accordance with Clause A.5. 6.7 Opening pressure The check valve shall open at a pressure of not more than 2 kPa when tested in accordance with A.6.1 and A.6.2 . NOTE An opening pressure of 2 kPa does not apply to “high-pressure valves ” such as anti-siphon valves and imaging valves. 6.8 Protective caps The protective caps shall cover the respective surfaces of the check valve to prevent contamination from surrounding environment, to avoid stick injuries and packaging damages. Protective caps should be secure but easily removable. 7 Chemical requirements The chemical requirements shall be in accordance with ISO 8536-4. 8 Biological requirements 8.1 General The check valve shall be assessed for biological compatibility in accordance with ISO 10993-1. 8.2 Sterility Sterility shall be in accordance with ISO 8536-4. 8.3 Pyrogenicity Pyrogenicity shall be in accordance with ISO 8536-4. 9 Labelling 9.1 General The labelling shall include the requirements as specified in 9.2 and 9.3 . If graphical symbols are used, then refer to ISO 15223-1. NOTE The presence of substances of interest can be indicated by using symbol ISO 7000-2725 by replacing the “XXX ” by the abbreviation of the substance. The absence of substances of interest can be indicated by crossing the respective symbol.
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) f) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol as given in ISO 15223-1; 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;
ISO 8536-12:2021 pdf download – Infusion equipment for medical use — Part 12: Check valves for single use
