1、April 2013 Translation by DIN-Sprachendienst.English price group 8No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 1
2、1.040.20!$E(“1973405www.din.deDDIN ISO 8536-12Infusion equipment for medical use Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012),English translation of DIN ISO 8536-12:2013-04Infusionsgerte zur medizinischen Verwendung Teil 12: Rckschlagventile (ISO 8536-12:2007 + Amd. 1:2012),Englische berse
3、tzung von DIN ISO 8536-12:2013-04Matriel de perfusion usage mdical Partie 12: Clapet antiretour (ISO 8536-12:2007 + Amd. 1:2012),Traduction anglaise de DIN ISO 8536-12:2013-04SupersedesDIN ISO 8536-12:2010-07www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be
4、considered authoritative.1203.13DIN ISO 8536-12:2013-04 2 A comma is used as the decimal marker. Contents Page National foreword .3 National Annex NA (informative) Bibliography 5 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Designation 7 5 Materials .7 6 Physical requirements 7 6.
5、1 Particulate contamination .7 6.2 Tensile strength .7 6.3 Leakage .7 6.4 Connecting pieces having internal and/or external connector .7 6.5 Counterflow pressure resistance .7 6.6 Volumetric flow rate.8 6.7 Blocking performance .8 6.8 Opening pressure 8 6.9 Protective caps 8 7 Chemical requirements
6、.8 8 Biological requirements 8 8.1 Sterility 8 8.2 Pyrogenicity .8 8.3 Biocompatibility .8 9 Packaging .8 10 Labelling .8 10.1 Unit container .8 10.2 Shelf or multi-unit container .9 Annex A (normative) Physical tests 10 DIN ISO 8536-12:2013-04 3 National foreword This standard has been prepared by
7、Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-02 AA Trans
8、fusions-/Infusionsbehltnisse und -gerte aus Kunststoffen. This document supersedes DIN ISO 8536-12:2010-07. The text of ISO 8536-12:2007/Amd.1:2012 has been adopted in this standard without any modification. The start and finish of text introduced or altered by amendment is indicated in the text by
9、tags !“. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. DIN and/or DKE shall not be held responsible for identifying any or all such patent rights. The DIN Standards corresponding to the International Standards referred to in thi
10、s document are as follows: ISO 594-2 DIN EN 1707 (identisch) ISO 7000 DIN ISO 7000 ISO 8536-4 DIN EN ISO 8536-4 ISO 8871-1 DIN EN ISO 8871-1 ISO 8871-2 DIN EN ISO 8871-2 ISO 10993-1 DIN EN ISO 10993-1 ISO 15223-1 DIN EN ISO 15223-1 DIN (EN) ISO 8536 consists of the following parts, under the general
11、 title Infusion equipment for medical use: Part 1: Infusion glass bottles (DIN EN ISO) Part 2: Closures for infusion bottles (DIN EN ISO) Part 3: Aluminium caps for infusion bottles (DIN EN ISO) Part 4: Infusion sets for single use, gravity feed (DIN EN ISO) Part 5: Burette infusion sets for single
12、use, gravity feed (DIN EN ISO) Part 6: Freeze drying closures for infusion bottles (DIN ISO) Part 7: Caps made of aluminium-plastics combinations for infusion bottles (DIN ISO) Part 8: Infusion equipment for use with pressure infusion apparatus (DIN EN ISO) Part 9: Fluid lines for use with pressure
13、infusion equipment (DIN EN ISO) Part 10: Accessories for fluid lines for use with pressure infusion equipment (DIN EN ISO) Part 11: Infusion filters for use with pressure infusion equipment (DIN EN ISO) Part 12: Check valves (DIN ISO) DIN ISO 8536-12:2013-04 4 Amendments This standard differs from D
14、IN ISO 8536-12:2010-07 as follows: a) Amendment 1:2012 has been incorporated (normative references, 6.2, 10.1, 10.2, A.3, A.4 and A.5); b) the standard has been editorially revised. Previous editions DIN 58362-7: 2002-09 DIN ISO 8536-12: 2010-07 DIN ISO 8536-12:2013-04 5 National Annex NA (informati
15、ve) Bibliography DIN EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Lock fittings DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for singl
16、e use, gravity feed DIN EN ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates DIN EN ISO 8871-2, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization DIN EN
17、ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN ISO 8536-12:2013-04 6 ISO
18、2007 All rights reservedInfusion equipment for medical use Part 12: Check valves 1 Scope 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 requiremen
19、ts in this part of ISO 8536 also apply to built-in check valves. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced docume
20、nt (including any amendments) applies. ISO 31-3, Quantities and units Part 3: Mechanics 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 sing
21、le 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, Biologi
22、cal evaluation of medical devices Part 1: Evaluation and testing within a risk management system !ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied General requirements“ 3 Terms and definitions For the purposes of this document, the
23、following terms and definitions apply. 3.1 blocking prevention of counterflow through the valve 3.2 built-in check valve check valve that is an integrated feature of the infusion set Infusion equipment for medical use Part 12: Check valvesDIN ISO 8536-12:2013-04 ISO 2007 All rights reserved 73.3 fee
24、d rate rate of flow through an open valve, flow in the forward direction 3.4 leakage rate rate of counterflow through a closed valve 4 Designation A check valve (CV) for infusions under gravity and/or pressure (P) is designated as follows: Check valve ISO 8536-12-CV-P 5 Materials The materials used
25、shall be chosen so that the check valves comply with the requirements specified in Clauses 6, 7 and 8. If rubber is used as a material, the requirements laid down in ISO 8871-1 and ISO 8871-2 shall apply. 6 Physical requirements 6.1 Particulate contamination The check valve shall be manufactured und
26、er conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the number of particles shall not exceed the contamination index. The requirements specified in ISO 8536-4 apply to built-in check valves. 6.2 Te
27、nsile strength When tested as specified in A.2, the check valve, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s. 6.3 Leakage There shall be no signs of air or water leakage in the test specified in A.3. 6.4 Connecting pieces having internal and/or ex
28、ternal connector Any connecting pieces shall have a fitting with an internal connector and/or a fitting with an external connector as specified in ISO 594-2. This applies to check valves with Luer lock connectors only. !Deleted text“ 6.5 Counterflow pressure resistance The check valve shall withstan
29、d a pressure of 200 kPa in the counterflow direction when it is tested as specified in A.5. DIN ISO 8536-12:2013-04 8 ISO 2007 All rights reserved6.6 Volumetric flow rate When the check valve is connected to the infusion equipment, the volumetric flow rate shall not be less than specified in accorda
30、nce with the test described in A.6. 6.7 Blocking performance The check valve shall close at a pressure of not more than 2 kPa in its counterflow direction valve when it is tested as specified in A.7. 6.8 Opening pressure The check valve shall open at a pressure of not more than 2 kPa when it is test
31、ed as specified in A.8.1. NOTE An opening pressure of 2 kPa does not apply to “high-pressure valves” such as anaesthesia valves. 6.9 Protective caps See ISO 8536-4. 7 Chemical requirements See ISO 8536-4. 8 Biological requirements 8.1 Sterility See ISO 8536-4. 8.2 Pyrogenicity See ISO 8536-4. 8.3 Bi
32、ocompatibility ISO 10993-1 shall be taken into account when assessing the biocompatibility of the check valve. 9 Packaging See ISO 8536-4. 10 Labelling 10.1 Unit container The unit container shall be labelled with the following minimum information: a) a textual description of the contents; b) indica
33、tion that the check valve is sterile, using the graphical symbol as given in !ISO 15223-1“; DIN ISO 8536-12:2013-04 ISO 2007 All rights reserved 9c) 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
34、for single use only, or equivalent wording, or using the graphical symbol according to !ISO 15223-1“; e) instructions for use, including warnings, e.g. about detached protective caps; NOTE Instructions for use can also take the form of an insert. f) the lot (batch) designation, prefixed by the word
35、LOT or using the graphical symbol according to !ISO 15223-1“; g) the wording “Safe for use with pressure infusion equipment“ !Deleted text“; h) identification block of designation according to Clause 4 (e.g. ISO 8536-12-CV-P); i) letter “P“ which stands for pressure and the type height which shall s
36、tand out clearly from surrounding text; j) name or logo and address of manufacturer or supplier; k) year and month of expiry, accompanied by appropriate wording or the graphical symbol according to !ISO 15223-1“. If the available space is too small to give all this information in legible characters
37、and/or symbols, the information may be reduced to f) and k). In this case the information as required in this subclause shall be given on the label of the next bigger shelf or multi-unit container. !NOTE The presence of substances of interest can be indicated by using symbol 2725 of ISO 7000 by repl
38、acing the “XXX” with the abbreviation of the substance. The absence of substances of interest can be indicated by crossing the respective symbol.“ 10.2 Shelf or multi-unit container The shelf or multi-unit container shall be labelled with the following minimum information: a) a textual description o
39、f the contents; b) the lot (batch) designation, prefixed by the word LOT or using the graphical symbol according to !ISO 15223-1“; c) the wording “Safe for use with pressure infusion equipment“ !Deleted text“; d) identification block of designation according to Clause 4 (e.g. ISO 8536-12-CV-P); e) l
40、etter “P“ which stands for pressure and the type height which shall stand out clearly from surrounding text; f) name or logo and address of manufacturer or supplier; g) year and month of expiry, accompanied by appropriate wording or the graphical symbol according to !ISO 15223-1“; h) storage note, i
41、f any. !NOTE The presence of substances of interest can be indicated by using symbol 2725 of ISO 7000 by replacing the “XXX” with the abbreviation of the substance. The absence of substances of interest can be indicated by crossing the respective symbol.“ DIN ISO 8536-12:2013-04 10 ISO 2007 All righ
42、ts reservedAnnex A (normative) Physical tests A.1 Test for particulate contamination The volume of the flushing liquid shall be equal to at least fifty times the internal volume of a test specimen. To determine the particulate contamination of a check valve, 20 specimens shall be treated with 100 ml
43、 of distilled water filtered through a membrane filter having a pore size of 0,2 m. The test shall be performed as specified in ISO 8536-4. A.2 Test for tensile strength Expose the check valve to be tested to a static tensile force of 15 N applied along the longitudinal axis for 15 s. Inspect whethe
44、r the check valve withstands the test force applied. ! A.3 Test for leakage of the valve housing A.3.1 At the beginning of the test the whole system shall be tempered at the test temperature. A.3.2 Immerse the check valve, with downstream end blocked, in water at 40 C and apply an internal air press
45、ure of 50 kPa for 15 s. Examine the check valve for air leakage. A.3.3 Subject the check valve, at both ends, to distilled water at an internal excess pressure of 200 kPa at 40 C for 15 min. Check for water leaks. A.3.4 Fill the built-in check valve with degassed distilled water at 40 C, connect the
46、 downstream opening, with the upstream opening sealed, to a vacuum device and subject it to an internal excess pressure of 20 kPa for 15 s. Inspect whether air enters the housing section of the check valve.“ !Deleted text“ A.4 Pressure resistance in counterflow direction !A.5 Volumetric flow rate Co
47、nnect the check valve to the infusion equipment and test as specified in ISO 8536-4:2004, 6.10. NOTE If the requirement in 6.6 is not met, the infusion equipment shall be tested without check valve. Subject the check valve to a water excess pressure of 200 kPa in the counterflow direction at 40 C fo
48、r 15 min in each case. Check for leakage through the check valve.“ DIN ISO 8536-12:2013-04 ISO 2007 All rights reserved 11A.6 Blocking performance Two tests shall be performed, one using distilled water and the other using a 40 % glucose solution. The tests shall be performed at least three times wi
49、th the check valve positioned horizontally and in the vertical position with upward and downward flow. The check valve shall be connected to the testing system as shown in the flow diagram in Figure A.1. In the case of permanently installed check valves, the lines shall be cut and a three-way stopcock with cannula inserted. Alternatively, the test liquid level may be lowered down into the line and marked. The entire system shall be filled with test liquids as specified, taking care to avo
