1、BS ISO 15674:2016Cardiovascular implants andartificial organs Hard-shellcardiotomy/venous reservoirsystems (with/without filter)and soft venous reservoir bagsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 15674:2016 BRITISH STANDARDNational forewordThis Briti
2、sh Standard is the UK implementation of ISO 15674:2016.It supersedes BS ISO 15674:2009 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/2, Cardiovascular implants.A list of organizations represented on this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 i
3、ts secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 89876 1ICS 11.040.40Compliance with a British Standard c
4、annot confer immunity fromlegal obligations.This British Standard was published under the authority 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 15674:2016 ISO 2016Cardiovascular implants and artifici
5、al organs Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bagsImplants cardiovasculaires et organes artificiels Systmes rservoirs de cardiotomie/veineux paroi dure (avec/sans filtre) et sacs rservoirs veineux mousINTERNATIONAL STANDARDISO15674Third edit
6、ion2016-08-15Reference numberISO 15674:2016(E)BS ISO 15674:2016ISO 15674:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any fo
7、rm 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 from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonne
8、t 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 15674:2016ISO 15674:2016(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 34.1 Biological characteristics . 34.1.1 Sterility and non-pyrog
9、enicity . 34.1.2 Biocompatibility . 34.2 Physical characteristics . 34.2.1 General 34.2.2 Blood volumes 44.2.3 Connectors 44.3 Performance characteristics 44.3.1 Blood cell damage . 44.3.2 Air-handling capacity . 44.3.3 Priming volume of the reservoirs in accordance with the manufacturers quality co
10、ntrol management system 44.3.4 Defoaming characteristics . 44.3.5 Volume calibration . 44.3.6 Filtration efficiency 54.3.7 Break-through volume 54.3.8 Dynamic priming volume . 54.3.9 Minimum and maximum volumes 54.3.10 Shelf life . 55 Tests and measurements to determine compliance with this document
11、 55.1 General . 55.2 Biological characteristics . 55.2.1 Sterility and non-pyrogenicity . 55.2.2 Biocompatibility . 65.3 Physical characteristics . 65.3.1 Blood pathway integrity for soft venous reservoir bags . 65.3.2 Blood pathway integrity for sealed hard-shell reservoirs . 65.3.3 Connectors 65.3
12、.4 Blood cell damage . 65.3.5 Filtration efficiency 75.3.6 Shelf life . 76 Information supplied by the manufacturer . 76.1 Information on the reservoir (labelling) 76.2 Information on the packaging 86.2.1 Information on the unit container 86.2.2 Information on the shipping container 86.3 Information
13、 in the accompanying documents . 86.4 Information in the accompanying documents in a prominent form 97 Packaging . 9Annex A (normative) Factors to be considered in evaluating performance characteristics .10Bibliography .11 ISO 2016 All rights reserved iiiContents PageBS ISO 15674:2016ISO 15674:2016(
14、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 technical committees. Each member body interested in a subject for which a
15、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 closely with the International Electrotechnical Commission (IEC) on all matter
16、s 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 needed for the different types of ISO documents should be noted. This docum
17、ent 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 patent rights. ISO shall not be held responsible for identifying any or all suc
18、h 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 in this document is information given for the convenience of users and does
19、 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) principles in the Technical Barriers to Trade (TBT) see the following URL: www.is
20、o.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.This third edition cancels and replaces the second edition (ISO 15674:2009), which has been technically revised.iv ISO 2016 A
21、ll rights reservedBS ISO 15674:2016INTERNATIONAL STANDARD ISO 15674:2016(E)Cardiovascular implants and artificial organs Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags1 ScopeThis document specifies requirements for sterile, single-use, extracorpor
22、eal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.This document applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas ex
23、changers (oxygenators), blood filters, defoamers, blood pumps, etc.2 Normative referencesThe 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 re
24、ferences, the latest edition of the referenced document (including any amendments) applies.ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization r
25、esidualsISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicityISO 11135, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 11137-1, Sterilization
26、 of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO
27、11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processesISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine contro
28、l of a sterilization process for medical devicesISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices3 Terms and definitionsFor the purposes of this document, the following
29、 terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at http:/www.iso.org/obp IEC Electropedia: available at http:/www.electropedia.org/ ISO 2016 All rights reserved 1BS ISO 15674:201
30、6ISO 15674:2016(E)3.1hard-shell cardiotomy reservoirextracorporeal device consisting of rigid walls designed to collect, defoam and filter suctioned blood3.2hard-shell venous reservoirextracorporeal device consisting of rigid walls designed to collect and defoam venous blood3.3soft-bag venous reserv
31、oirextracorporeal device consisting of collapsible, pliable walls designed to collect venous blood3.4hard-shell cardiotomy/venous reservoir systemextracorporeal device designed to function simultaneously as both a venous reservoir and cardiotomy reservoir3.5blood-gas exchangeroxygenatorextracorporea
32、l device designed to supplement, or be a substitute for, the respiratory function of the lungs3.6integral partpart that is connected to the reservoir or is part of the reservoir system that cannot normally be separated by the user3.7operating variablesetting of controls which affects the function of
33、 the device3.8static volumepriming volume present in the device at zero flow3.9break-through volumevolume of fluid that, when added during the initial priming of the dry device (as received from the manufacturer), must be exceeded before fluid first exits the device3.10sealed hard-shell reservoirhar
34、d-shell reservoir that may be operated at either positive or negative pressure3.12dynamic priming volumeamount of fluid volume that is contained inside the defoamer/filter compartment at a specified flow rate and, for soft bag reservoir, depending on the head pressure and the position of the compres
35、sion mechanismNote 1 to entry: The dynamic priming volume can be affected by negative pressure applied to a hard-shell reservoir.3.13platelet reductionpercentage reduction of platelets contained in a circuit as a function of time3.14plasma-free haemoglobin levelconcentration of plasma-free haemoglob
36、in in a circuit as a function of time2 ISO 2016 All rights reservedBS ISO 15674:2016ISO 15674:2016(E)3.14.1normalized index of hemolysisNIHgrams of plasma-free hemoglobin released after pumping 100 L of bloodNIHfHb VHctQTgL/100100100100()=wherefHb increase of plasma free hemoglobin concentration (g/
37、L) over the sampling time interval;V circuit volume (L);Q flow rate (L/min);Hct hematocrit (%);T sampling time interval (min)3.15white blood cell reductionpercentage reduction of white blood cells contained in a circuit as a function of time3.16predicate reservoirsimilar reservoir to the test reserv
38、oir that has previously been approved and used for the same intended clinical use3.17filtration efficiencyability of the filter to remove particles from the simulated blood suspension test fluid, expressed as a percentage4 Requirements4.1 Biological characteristics4.1.1 Sterility and non-pyrogenicit
39、yThe blood pathway shall be sterile and non-pyrogenic.Compliance shall be verified in accordance with 5.2.1.4.1.2 BiocompatibilityAll 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 characteristic
40、s4.2.1 GeneralWhen tested in accordance with 5.3.1 and 5.3.2, the blood pathway shall not leak. ISO 2016 All rights reserved 3BS ISO 15674:2016ISO 15674:2016(E)4.2.2 Blood volumesThe volume of the blood pathway shall be within the tolerances specified by the manufacturer see 6.3 k).4.2.3 ConnectorsC
41、onnectors for connection to the blood pathway shall, when tested in accordance with 5.3.4, allow a secure connection.NOTE 1 Connectors of a type that allows connection of tubes with an inner 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 typ
42、e that complies with ISO 594-2, have been used.NOTE 2 Connectors corresponding to ISO 8637:2010, Figure 3 are considered as one way to comply with this requirement.4.3 Performance characteristicsNOTE 1 Guidance for testing is given in Annex A.NOTE 2 Some of these tests can be combined and performed
43、at the same time.4.3.1 Blood cell damage4.3.1.1 Plasma-free haemoglobinWhen determined in accordance with 5.3.4, the increased concentration of plasma-free haemoglobin shall be within the range of values specified by the manufacturer.The hemolysis results shall be reported as mg/dL and NIH.4.3.1.2 P
44、latelet reduction and white blood cell reductionWhen determined in accordance with 5.3.4, the percentage reduction of platelets and the percentage reduction of white blood cells shall be within the range of values specified by the manufacturer.4.3.2 Air-handling capacityTesting to demonstrate the ai
45、r-handling characteristics shall be conducted at various flow rates and the results shall be recorded see 6.3 p). The test shall be conducted according to the manufacturers protocols.4.3.3 Priming volume of the reservoirs in accordance with the manufacturers quality control management systemThe volu
46、me of the reservoir(s) shall be determined and the results presented in accordance with 6.3 o). Testing shall be conducted according to the manufacturers protocols.4.3.4 Defoaming characteristicsWhere applicable, the defoaming characteristics shall be determined and the results shall be recorded see
47、 6.3 p). The testing shall be conducted according to the manufacturers protocols.4.3.5 Volume calibrationWhere applicable, the accuracy of the volume markings shall be measured and tolerances shall be presented as required in 6.3 n). The testing shall be conducted according to the manufacturers prot
48、ocols.4 ISO 2016 All rights reservedBS ISO 15674:2016ISO 15674:2016(E)4.3.6 Filtration efficiencyThe efficiency of the filter shall be determined by the manufacturer according to their protocol. The filter efficiency results shall be recorded see 6.3 p). The testing shall be performed around the ant
49、icipated flow range of the filter.4.3.7 Break-through volumeWhere applicable, the break-through volume shall be measured and the results shall be recorded see 6.3 p). The testing shall be performed according to the manufacturers protocols.4.3.8 Dynamic priming volumeWhere applicable, the dynamic priming volume applies to hard-shell cardiotomy/venous reservoir systems (with/without filter) and shall be measured and reported as in 6.3 k). Results shall indicate the priming volume over the entire
