1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 11658:2012Cardiovascular implantsand extracorporeal systems Blood/tissue contactsurface modifications forextracorporeal perfusionsystemsBS ISO 11658:2012 BRITISH STANDARDN
2、ational forewordThis British Standard is the UK implementation of ISO 11658:2012.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 publica
3、tion does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 71492 4ICS 11.040.40Compliance with a British Standard cannot confer immunity fro
4、mlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 May 2012.Amendments issued since publicationDate Text affectedBS ISO 11658:2012 ISO 2012Cardiovascular implants and extracorporeal systems Blood/tissue contact surface modif
5、ications for extracorporeal perfusion systemsImplants cardiovasculaires et systmes extracorporels Revtements pour lquipement au contact du sangINTERNATIONAL STANDARDISO11658First edition2012-05-15Reference numberISO 11658:2012(E)BS ISO 11658:2012ISO 11658:2012(E)ii ISO 2012 All rights reservedCOPYRI
6、GHT PROTECTED DOCUMENT ISO 2012All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
7、 ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 11658:2012ISO 11658:2012(E)ForewordISO (the International Organization for Standardiz
8、ation) 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 technical committee has been established has the right to be
9、 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 matters of electrotechnical standardization.International Standard
10、s are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Internat
11、ional Standard requires approval by at least 75 % of the member bodies casting a vote.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 such patent rights.ISO 11658 was pr
12、epared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems. ISO 2012 All rights reserved iiiBS ISO 11658:2012ISO 11658:2012(E)IntroductionThis International Standard is intended to ensure that devices that have surface modifi
13、ed blood-contacting surfaces are tested for their safety, integrity and function, and that extracorporeal device characteristics are appropriately disclosed when labelling the device. This International Standard also includes minimum reporting requirements, which will allow the user to compare prope
14、rties in a standard way.This International Standard therefore contains recommended procedures to be used for evaluation of modified surfaces. The requirements for determination of the surface coverage, leaching and biological activity, if claimed, of the surface modification are addressed, although
15、limits for these requirements are not specified.This International Standard makes reference to other International Standards in which methods for determination of characteristics common to medical devices can be found.Requirements for animal and clinical studies have not been included in this Intern
16、ational Standard.Additional requirements are covered by references to other International Standards listed in the normative references.iv ISO 2012 All rights reservedBS ISO 11658:2012Cardiovascular implants and extracorporeal systems Blood/tissue contact surface modifications for extracorporeal perf
17、usion systems1 ScopeThis International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart-lung bypass equipment and of extracorporeal life supp
18、ort equipment that carry blood and have modifications on the blood and tissue-contacting surfaces of the device. The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If hyperthermia (37 C) applications are indicated, then testing is performed over
19、 the indicated range.2 Normative referencesThe 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 document (including any amendments) applies.ISO 719
20、9, Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)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 residuals
21、ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicityISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-1, Sterilization o
22、f health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and ro
23、utine control of a sterilization process for medical devicesISO 15674, Cardiovascular implants and artificial organs Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bagsISO 15675, Cardiovascular implants and artificial organs Cardiopulmonary bypass syst
24、ems Arterial blood line filtersISO 15676, Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the develop
25、ment, 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 11658:2012(E) ISO 2012 All rights reserved 1BS ISO 11658:2012ISO 11658:2012(E)3.1surface m
26、odificationmodification that can be biologically derived or non-biologically derived and can be applied to blood-contacting surfaces or additives incorporated into a material as part of the manufacturing process3.2coverageextent to which a surface modification applied to a blood contact device effec
27、tively covers the blood or tissue-contacting surface of the device3.3leachingextent to which a surface modification applied to the surface of a blood contact device may elute from the surface of the device directly contacting the patient or into the fluid stream which in turn contacts the patient3.4
28、bioactivityquantification of any biological activity that a surface modification applied to the surface of a blood contact device imparts to the blood or tissues to which it is exposed4 Requirements4.1 Biological characteristics4.1.1 Sterility and non-pyrogenicityThe blood pathway shall be sterile a
29、nd non-pyrogenic. Compliance shall be verified in accordance with 5.2.1.4.1.2 BiocompatibilityParts of the blood pathway shall be biocompatible with respect to their intended use. Compliance shall be verified in accordance with 5.2.2.4.1.3 Biological activityIf any claims of biological activity are
30、made by the manufacturer, then quantification of such claims shall be verified by the manufacturer in accordance with 5.2.3.4.2 Physical characteristics4.2.1 Blood pathway integrityWhen tested in accordance with 5.3.1, the blood pathway shall not leak.4.2.2 Blood pathway coverageThe surfaces which a
31、re covered by the surface modification shall be verified by the manufacturer in accordance with 5.3.2.4.2.3 Surface modification integrityThe integrity of the surface modification shall be verified by the manufacturer in accordance with 5.3.3.2 ISO 2012 All rights reservedBS ISO 11658:2012ISO 11658:
32、2012(E)4.3 Performance characteristics4.3.1 Blood cell damageWhen determined in accordance with 5.4.1, the percentage change (positive or negative) of plasma-free haemoglobin, platelets and white blood cells shall be within the range of values specified by the manufacturer.4.3.2 General performanceW
33、hen determined in accordance with 5.4.2, the ability of the device to perform its intended function with the biocompatible surface modification in place shall be verified by the manufacturer.4.3.3 Shelf lifeWhen tested in accordance with 5.4.3, test results shall demonstrate the rated shelf life.5 T
34、ests5.1 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 Operating variables shall be those specified by the manufacturer for intended clinical use, unles
35、s otherwise specified.5.1.3 The temperature of the test liquid(s) shall be representative of a range of the intended clinical temperatures during device use (e.g. hypothermic, normothermic and/or hyperthermic). Tests should be performed at multiple temperatures over the range of the intended clinica
36、l 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 If the relationship between variables is non-linear, sufficient determinations shall be made to permit valid interpolation between data point
37、s.5.1.5 The test or measurement procedures are to be regarded as reference procedures. Other procedures can be accepted, provided that the alternative procedure has been shown to be of comparable precision and reproducibility.5.2 Biological characteristics5.2.1 Sterility and non-pyrogenicityComplian
38、ce shall be verified by inspection of the manufacturers documentation on sterilization and pyrogen testing, in accordance with ISO 17665-1, ISO 11135-1, ISO 11137-1, ISO 14937 or ISO 10993-11, as applicable.5.2.2 BiocompatibilityCompliance shall be verified by test or by inspection of the manufactur
39、ers documentation on biocompatibility for the finished device, in accordance with ISO 10993-1 and ISO 10993-7, as applicable. ISO 2012 All rights reserved 3BS ISO 11658:2012ISO 11658:2012(E)5.2.3 Biological activityAny biological activity claims shall be verified using validated methodology performe
40、d according to the manufacturers protocol. This shall not apply to surface modifications for which biological activity is not claimed.EXAMPLE A claim of heparin activity can be verified with a test to evaluate the anticoagulant activity in terms of antithrombin uptake and the concomitant thrombin in
41、hibitory capacity of the heparin present in the surface modification.5.3 Physical characteristics5.3.1 Determination of blood pathway integrity (sterile final assembly)Devices that have established standards, such as oxygenators, reservoirs, tubing packs and arterial filters, shall use the prescribe
42、d methodology from their respective standard for testing.In the absence of an established standard, subject the blood pathway of the device, filled with water, to a negative or positive pressure of 1,5 times the manufacturers rated pressure, or, if none is given, to a pressure of 152 kPa (22 psi) ga
43、uge. Maintain this pressure for 6 h or for the intended use time specified by the manufacturer. Visually inspect the device for evidence of water leakage.5.3.2 Determination of surface modification coverageAny surface modification coverage claims shall be verified using validated methodology perform
44、ed according to the manufacturers protocol.EXAMPLE A claim of coverage for a heparin-containing surface modification can be verified by treating coated devices with the cationic dye, toluidine blue. The dye is absorbed onto the negatively charged surface inducing a metachromatic shift in the colour
45、of the dye (blue to purple). The coverage of the stained surface is then visually inspected for purple colour distribution.5.3.3 Determination of surface modification integrityThe integrity of the surface modification shall be verified using validated methodology performed according to the manufactu
46、rers protocol.Such testing shall be performed using an appropriate extraction media under conditions simulating the maximum rated conditions as specified for the device. These conditions shall include the temperature, flow rate, pressure, duration of testing (6 h or intended duration of use), and me
47、chanical stress (such as roller pump compression of tubing indicated for use in a roller pump) for the intended purpose of the device specified by the manufacturer.5.4 Performance characteristics5.4.1 Blood cell damageDevices that have established standards, such as oxygenators, reservoirs, tubing p
48、acks and arterial filters, shall use the prescribed methodology from their respective standard for testing.In the absence of an established standard, the manufacturer shall assess the blood cell trauma of the device according to the manufacturers internal procedures.5.4.2 General performanceDevice p
49、erformance that is expected to be affected by the surface modification shall be tested.Devices that have established standards, such as oxygenators, reservoirs, tubing packs and arterial filters, shall use the prescribed methodology from their standard for testing.In the absence of an established standard, the manufacturer shall assess the performance characteristics of the device as per the manufacturers internal procedures.4 ISO 2012 All rights reservedBS ISO 11658:2012ISO 11658:2012(E)5.4.3 Shelf lifeUsing a
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