1、BS ISO 18242:2016Cardiovascular implants andextracorporeal systems Centrifugal blood pumpsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 18242:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18242:2016.The UK partic
2、ipation 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 contract. Users are responsi
3、ble for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 81391 7ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Pol
4、icy 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 18242:2016 ISO 2016Cardiovascular implants and extracorporeal systems Centrifugal blood pumpsImplants cardiovasculaires et systmes extracorporels Pompes sanguines centrifuges
5、INTERNATIONAL STANDARDISO18242First edition2016-09-01Reference numberISO 18242:2016(E)BS ISO 18242:2016ISO 18242:2016(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 re
6、produced 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 from either ISO at the address below or ISOs member body in the country of the reques
7、ter.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 18242:2016ISO 18242:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 34.1 Biolo
8、gical 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 Connector integrity 34.3 Performance characteristics 34.3.1 Hydraulic performance 34.3.2 Blood cell damage . 34.3.3 Bear
9、ing durability . 44.3.4 Shelf life . 45 Tests and measurements to determine compliance with this document 45.1 General . 45.1.1 Tests and measurements 45.1.2 Operating variables . 45.1.3 Temperature 45.1.4 Relationship between variables 45.1.5 Procedures 55.1.6 Driver/console . 55.2 Biological chara
10、cteristics . 55.2.1 Sterility and non-pyrogenicity . 55.2.2 Biocompatibility . 55.3 Physical characteristics . 55.3.1 Blood pathway integrity 55.3.2 Prime volume 55.3.3 Connectors 55.4 Performance characteristics 65.4.1 Hydraulic performance 65.4.2 Blood cell damage . 65.4.3 Bearing wear . 75.4.4 Sh
11、elf life . 76 Information supplied by the manufacturer . 76.1 Information on the device . 76.2 Information on the packaging 86.2.1 Unit container . 86.2.2 Shipping container . 86.3 Information in the accompanying documents . 86.4 Information in the accompanying documents in a prominent form 97 Packa
12、ging . 9Bibliography .10 ISO 2016 All rights reserved iiiContents PageBS ISO 18242:2016ISO 18242:2016(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 normal
13、ly carried out through ISO 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
14、 work. ISO collaborates closely 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 d
15、ifferent approval criteria 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
16、 may be the subject of patent 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/pa
17、tents).Any trade name used 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 Trad
18、e Organization (WTO) principles 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
19、reservedBS ISO 18242:2016ISO 18242:2016(E)IntroductionThis document is intended to ensure that devices designed to provide continuous flow of blood in support of, or as a substitution for, the normal pumping function of the heart have been adequately tested for both their safety and function, and th
20、at extracorporeal device characteristics are appropriately disclosed when labelling the device.This document therefore contains procedures to be used for evaluation of extracorporeal centrifugal blood pumps. Test procedures for determination of the hydraulic performance, blood cell damage and other
21、performance characteristics are described, although limits for these characteristics are not specified. Ready identification of the performance characteristics should, however, assist the user in the selection of a centrifugal blood pump that will suit the needs of the patient.This document also inc
22、ludes minimum reporting requirements, which will allow the user to compare performance characteristics of centrifugal blood pumps of different designs in a standard way.This document makes reference to other International Standards in which methods for determination of characteristics common to medi
23、cal devices can be found.Requirements for animal 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 centrifugal blood pumps. Non-specific requirements are covered
24、 by references to other International Standards listed in Clause 2. ISO 2016 All rights reserved vBS ISO 18242:2016BS ISO 18242:2016Cardiovascular implants and extracorporeal systems Centrifugal blood pumps1 ScopeThis document specifies requirements for sterile, single-use, extracorporeal centrifuga
25、l blood pumps, whether coated, non-surface modified, or surface-modified, intended for producing blood flow during extracorporeal circulation. Such blood flow is most commonly used to provide systemic perfusion during cardiopulmonary bypass, but also has applications for veno-venous bypass, kinetic-
26、assisted venous drainage, or extracorporeal membrane oxygenation.This document does not apply to centrifugal pumps used as ventricular assist devices, and other components of extracorporeal circuits (e.g. blood tubing, pump console/driver).2 Normative referencesThe following documents are referred t
27、o 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 10993-1, Biological evaluation o
28、f medical devices Part 1: Evaluation and testing within a risk management processISO 10993-4, Biological evaluation of medical devices Part4: Selection of tests for interactions with bloodISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residualsISO 10993-11
29、, 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 of health care prod
30、ucts 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 11607-2, Packaging f
31、or terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processesISO 11658, Cardiovascular implants and extracorporeal systems Blood/tissue contact surface modifications for extracorporeal perfusion systemsISO 17665-1, Sterilization of health care p
32、roducts 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 terms and definitions apply.INTERNATIONAL STANDARD ISO 18242:2016(E) ISO 2016 All rights r
33、eserved 1BS ISO 18242:2016ISO 18242:2016(E)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/3.1centrifugal blood pumpextracor
34、poreal device designed to produce rotational flow by means of radial force3.2blood pathwaypaths of the pump containing blood during intended clinical use3.3operating variablessettings of controls that affect the function of the device3.4blood cell damageloss or destruction of cellular components of
35、the blood3.5platelet reductionpercentage reduction of platelets contained in a circuit incorporating a centrifugal pump as a function of time3.6plasma-free hemoglobin levelconcentration of plasma-free hemoglobin in a circuit incorporating a pump, as a function of time3.6.1normalized index of hemolys
36、isNIHgrams of plasma-free hemoglobin released after pumping 100 L of bloodNIHg LfHb VHctQT/100100100100= (1)wherefHb is the increase of plasma free hemoglobin concentration (g/L) over the sampling time interval;V is circuit volume (L);Q is flow rate (L/min);Hct is hematocrit (%);T is sampling time i
37、nterval (min).3.7white blood cell reductionpercentage reduction of white blood cells contained in a circuit incorporating a centrifugal pump as a function of time2 ISO 2016 All rights reservedBS ISO 18242:2016ISO 18242:2016(E)3.8blood analoguetest solution which simulates blood viscosity between 2,0
38、 103Pas (2,0 cP), to 3,5 103Pas (3,5 cP) or defined by the manufacturer based on appropriate haematocrit and temperature of the circulating blood during intended clinical use (i.e. hypothermic conditions)3.9predicate pumpsimilar pump to the test pump that has previously been approved and used for th
39、e same intended clinical use4 Requirements4.1 Biological characteristics4.1.1 Sterility and non-pyrogenicityThe 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 res
40、pect to their intended use. Compliance shall be verified in accordance with 5.2.2.4.2 Physical characteristics4.2.1 Blood pathway integrityWhen determined in accordance with 5.3.1, the blood pathway shall not leak.4.2.2 Prime volumeWhen determined in accordance with 5.3.2, the volume of the blood pa
41、thway shall be within the tolerances specified by the manufacturer (see 6.3).4.2.3 Connector integrityWhen determined in accordance with 5.3.3, the inlet and outlet ports shall allow a secure connection.NOTE Connectors of a type that allow connection of tubes with an inner diameter of 4,8 mm, 6,3 mm
42、, 9,5 mm, or 12,7 mm, or a type that complies with ISO 7199.4.3 Performance characteristics4.3.1 Hydraulic performanceWhen determined in accordance with 5.4.1, the flow rates, pressure, and revolutions per minute (r/min) shall be within the range of values specified by the manufacturer (see 6.3).4.3
43、.2 Blood cell damageNOTE Testing performed at the maximum rated flow specified by the manufacturer and using appropriate circuit blood volume, backpressure, pump r/min, and temperature is one way to comply with this requirement. ISO 2016 All rights reserved 3BS ISO 18242:2016ISO 18242:2016(E)4.3.2.1
44、 Plasma-free hemoglobinWhen determined in accordance with 5.4.2, the rate of generation of plasma-free hemoglobin shall be within the range of values specified by the manufacturer.The hemolysis results shall be reported as mg/dL and NIH.4.3.2.2 Platelet reductionWhen determined in accordance with 5.
45、4.2, the percentage reduction of platelets shall be within the range of values specified by the manufacturer.4.3.2.3 White blood cell reductionWhen determined in accordance with 5.4.2, the percentage reduction of white blood cells shall be within the range of values specified by the manufacturer.4.3
46、.3 Bearing durabilityWhen determined in accordance with 5.4.4, the bearing shall remain functional over the duration of the testing specified by the manufacturer, unless the device is bearingless.4.3.4 Shelf lifeWhen tested in accordance with 5.4.4, test results shall demonstrate the rated shelf lif
47、e, as specified by the manufacturer.5 Tests and measurements to determine compliance with this document5.1 General5.1.1 Tests and measurementsTests and measurements shall be performed with the device under test prepared according to the manufacturers instructions for intended clinical use and in acc
48、ordance with the manufacturers specified test methodology.5.1.2 Operating variablesOperating variables shall be those specified by the manufacturer for intended clinical use, unless otherwise specified.5.1.3 TemperatureThe temperature of the test liquid(s) shall be representative of a range of the i
49、ntended temperatures during clinical use of the device (e.g. hypothermic, normothermic, and/or hyperthermic). Tests should be performed at multiple temperatures over the range of the intended clinical use, or justification for testing at a single temperature should be provided (e.g. why this temperature is representative of the worst case condition).5.1.4 Relationship between variablesIf the relationship between variables is non-linear, sufficient determinations shall be made to permit valid interpola
