1、BS ISO 18241:2016Cardiovascular implants andextracorporeal systems Cardiopulmonary bypasssystems Venous bubbletrapsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 18241:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO
2、 18241:2016.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/2, Cardiovascular implants.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a con
3、tract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 81390 0ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the auth
4、ority of theStandards Policy and Strategy Committee on 31 August 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 18241:2016 ISO 2016Cardiovascular implants and extracorporeal systems Cardiopulmonary bypass systems Venous bubble trapsImplants cardiovasculaires et
5、 systmes extracorporels Systmes de pontage cardiopulmonaire Piges bulles veineusesINTERNATIONAL STANDARDISO18241First edition2016-08-15Reference numberISO 18241:2016(E)BS ISO 18241:2016ISO 18241:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll
6、rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested fro
7、m either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 18241:2016ISO 18241:2016(E)Foreword ivIntroduction v1 Sco
8、pe . 12 Normative references 13 Terms and definitions . 14 Requirements 34.1 Biological characteristics . 34.1.1 Sterility and non-pyrogenicity . 34.1.2 Biocompatibility . 34.2 Physical characteristics . 34.2.1 Blood pathway integrity 34.2.2 Prime volume 34.2.3 Connectors 34.3 Performance characteri
9、stics 34.3.1 Blood cell damage . 34.3.2 Air removal efficiency 34.3.3 Flow rate capacity . 34.3.4 Shelf life . 45 Tests and measurements to determine compliance with this document 45.1 General . 45.2 Biological characteristics . 45.2.1 Sterility and non-pyrogenicity . 45.2.2 Biocompatibility . 45.3
10、Physical characteristics . 45.3.1 Blood pathway integrity 45.3.2 Prime volume 45.3.3 Connectors 45.4 Performance characteristics 55.4.1 Blood cell damage . 55.4.2 Air removal efficiency 65.4.3 Flow rate and pressure drop . 65.4.4 Shelf life . 76 Information supplied by the manufacturer . 76.1 Inform
11、ation on the venous bubble trap 76.2 Information on the packaging 76.2.1 Information on the unit container 76.2.2 Information on the shipping container 76.3 Information in the accompanying documents . 86.4 Information in the accompanying documents in a prominent form 87 Packaging . 8Bibliography 9 I
12、SO 2016 All rights reserved iiiContents PageBS ISO 18241:2016ISO 18241:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
13、 technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates cl
14、osely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria
15、 needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of pat
16、ent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used
17、 in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) princ
18、iples in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.iv ISO 2016 All rights reservedBS ISO 18241:2016I
19、SO 18241:2016(E)IntroductionThis document is intended to ensure that devices designed to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support have been adequately tested for both their safety and function, and that extracorporeal device characte
20、ristics are appropriately disclosed when labeling the device.This document therefore contains procedures to be used for evaluation of extracorporeal venous bubble traps. Test procedures for determination of the air removal efficiency, blood cell damage and other performance characteristics are descr
21、ibed, although limits for these characteristics are not specified. Ready identification of the performance characteristics should, however, assist the user in the selection of a venous bubble trap that will suit the needs of the patient.This document also includes minimum reporting requirements, whi
22、ch will allow the user to compare performance characteristics of venous bubble traps of different designs in a standard way.This document makes reference to other International Standards in which methods for determination of characteristics common to medical devices can be found.Requirements for ani
23、mal and clinical studies have not been included in this document.Such studies may be part of a manufacturers quality system.This document contains only those requirements that are specific to venous bubble traps. Nonspecific requirements are covered by references to other International Standards lis
24、ted in the normative references section. ISO 2016 All rights reserved vBS ISO 18241:2016BS ISO 18241:2016Cardiovascular implants and extracorporeal systems Cardiopulmonary bypass systems Venous bubble traps1 ScopeThis document specifies requirements for sterile, single-use, venous bubble traps inten
25、ded to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support, which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or venovenous bypass for liver transplantation.2 Normative referencesThe following documents
26、 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 594-2, Conical fi
27、ttings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittingsISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 10993-4, Biological evaluation of medical devices Part 4: Selection of
28、tests for interaction with bloodISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residualsISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicityISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Req
29、uirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11607-1, Packagi
30、ng for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processesISO 14937, Sterilization of health
31、 care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and rou
32、tine control of a sterilization process for medical devices3 Terms and definitionsFor 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
33、at https:/www.iso.org/obp/ IEC Electropedia: available at http:/www.electropedia.org/INTERNATIONAL STANDARD ISO 18241:2016(E) ISO 2016 All rights reserved 1BS ISO 18241:2016ISO 18241:2016(E)3.1venous bubble trapdevice for removing air from the venous line of an extracorporeal circuit3.2blood pathway
34、blood-contacting surfaces of the venous bubble trap during its intended clinical use3.3blood cell damageloss or destruction of cellular components of the blood3.4platelet reductionpercentage reduction of platelets contained in a circuit incorporating a venous bubble trap, as a function of time3.5pla
35、sma-free hemoglobin leveldifference between the concentration of plasma-free hemoglobin in a circuit incorporating a venous bubble trap, as a function of time3.5.1normalized index of hemolysisNIHgrams of plasma-free hemoglobin released after pumping 100 l of bloodNIHg LfHb VHctQT/100100100100=wheref
36、Hb is the increase of plasma free hemoglobin concentration (g/L) over the sampling time interval;V is the circuit volume (L);Q is the flow rate (L/min);Hct is the hematocrit (%);T is the sampling time interval (min)3.6white blood cell reductionpercentage reduction of white blood cells contained in a
37、 circuit incorporating a venous bubble trap, as a function of time3.7air removal efficiencyability of the venous bubble trap to remove air from the blood, expressed as a percentage3.8blood analoguetest solution which simulates blood viscosity between 2,0 103Pas (2,0 cP), to 3,5 103Pas (3,5 cP)3.9pre
38、dicate venous bubble trapsimilar venous bubble trap to the test venous bubble trap that has previously been approved and used for the same intended clinical use2 ISO 2016 All rights reservedBS ISO 18241:2016ISO 18241:2016(E)4 Requirements4.1 Biological characteristics4.1.1 Sterility and non-pyrogeni
39、cityThe blood pathway shall be sterile and non-pyrogenic. Compliance shall be verified in accordance with 5.2.1.4.1.2 BiocompatibilityThe parts of the blood pathway shall be biocompatible with respect to their intended use. Compliance shall be verified in accordance with 5.2.2.4.2 Physical character
40、istics4.2.1 Blood pathway integrityWhen tested in accordance with 5.3.1, the blood pathway shall not leak.4.2.2 Prime volumeThe volume of the blood pathway shall be within the tolerances specified by the manufacturer (see 6.3).4.2.3 ConnectorsConnectors for connection to the blood pathway shall, whe
41、n tested in accordance with 5.3.3, allow a secure connection.NOTE 1 Connectors of a type that allows connection of tubes with an inside diameter of 4,8 mm, 6,3 mm, 9,5 mm or 12,7 mm, or a type that complies with ISO 8637:2010, Figure 1, or a type that complies with ISO 594-2, have been found satisfa
42、ctory.Connection for accessory ports shall meet the requirements of ISO 594-2.NOTE 2 Connectors corresponding to ISO 8637:2010, Figure 3, are considered as one way to comply with this requirement.4.3 Performance characteristics4.3.1 Blood cell damageWhen determined in accordance with 5.4.1, the perc
43、entage change (positive or negative) of plasma-free hemoglobin, platelets, and white blood cells, shall be within the range of values specified by the manufacturer.The hemolysis results shall be reported as mg/dL and NIH.4.3.2 Air removal efficiencyWhen tested in accordance with 5.4.2, the air remov
44、al efficiency shall be as expressed as a percentage. The manufacturer should specify the air challenge conditions. The test methodology should account for and measure gaseous microemboli for size and number and a second measurement of gross air volume.4.3.3 Flow rate capacityWhen tested in accordanc
45、e with 5.4.3, the test results shall demonstrate the flow rate and pressure limitation(s), as specified by the manufacturer. ISO 2016 All rights reserved 3BS ISO 18241:2016ISO 18241:2016(E)4.3.4 Shelf lifeWhen tested in accordance with 5.4.4, the test results shall demonstrate the rated shelf life,
46、as specified by the manufacturer.5 Tests and measurements to determine compliance with this document5.1 General5.1.1 Tests and measurements shall be performed with the device in its terminally sterilized form and prepared according to the manufacturers instructions for intended clinical use.5.1.2 Op
47、erating variables shall be those specified by the manufacturer for intended clinical use, unless otherwise specified.5.1.3 Unless otherwise stated, the temperature of test liquids shall be 37 C 1 C.5.1.4 If the relationship between variables is non-linear, sufficient determinations shall be made to
48、permit valid interpolation between data points.5.1.5 The test or measurement procedures shall be regarded as reference procedures. Other procedures can be accepted, provided that the alternative procedure has been shown to be of comparable precision.5.2 Biological characteristics5.2.1 Sterility and
49、non-pyrogenicityCompliance shall be verified by inspection of the manufacturers documentation on sterilization and pyrogen testing, in accordance with ISO 10993-11, ISO 11135-1, ISO 11137-1, ISO 14937 or ISO 17665-1, as applicable.5.2.2 BiocompatibilityCompliance shall be verified by test or by inspection of the manufacturers documentation on biocompatibility for the finished device, in accordance with ISO 10993-1 and ISO 10993-7, as applicable.5.3 Physical characteristics5.3.1 Blood
