BS ISO 15675-2016 Cardiovascular implants and artificial organs Cardiopulmonary bypass systems Arterial blood line filters《心血管植入物和人造器官 心肺旁路系统 动脉血管路过滤器》.pdf

1、BS ISO 15675:2016Cardiovascular implantsand artificial organs Cardiopulmonary bypasssystems Arterial blood linefiltersBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 15675:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of

2、ISO 15675:2016. It supersedes BS ISO 15675:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/150/2, Cardiovascular implants.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does no

3、t purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 89877 8 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal

4、obligations.This British Standard was published under the authority of the Standards 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 15675:2016 ISO 2016Cardiovascular implants and artificial organs Cardiopulmonary bypas

5、s systems Arterial blood line filtersImplants cardiovasculaires et organes artificiels Systmes de pontage cardio-pulmonaire Filtres en ligne pour sang artrielINTERNATIONAL STANDARDISO15675Third edition2016-08-15Reference numberISO 15675:2016(E)BS ISO 15675:2016ISO 15675:2016(E)ii ISO 2016 All rights

6、 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 form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an

7、 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 Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.or

8、gwww.iso.orgBS ISO 15675:2016ISO 15675:2016(E)Foreword iv1 Scope . 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.

9、2.2 Blood volume 34.2.3 Connectors 34.3 Performance characteristics 34.3.1 Blood cell damage . 34.3.2 Filtration efficiency 34.3.3 Flow rate capacity . 44.3.4 Shelf life . 44.3.5 Air-handling capability . 45 Tests and measurements to determine compliance with this document 45.1 General . 45.2 Biolog

10、ical characteristics . 45.2.1 Sterility and non-pyrogenicity . 45.2.2 Biocompatibility . 45.3 Physical characteristics . 45.3.1 Blood pathway integrity (sterile final assembly) 45.3.2 Blood volume 55.3.3 Connectors 55.4 Performance characteristics 55.4.1 Blood cell damage . 55.4.2 Filtration efficie

11、ncy 65.4.3 Filter flow rate . 65.4.4 Shelf life . 65.4.5 Air-handling capability . 66 Information supplied by the manufacturer . 76.1 Information on the arterial blood line filter 76.2 Information on the packaging 76.2.1 Information on the unit container 76.2.2 Information on the shipping container

12、76.3 Information in the accompanying documents . 86.4 Information in the accompanying documents in a prominent form 87 Packaging . 8Bibliography 9 ISO 2016 All rights reserved iiiContents PageBS ISO 15675:2016ISO 15675:2016(E)ForewordISO (the International Organization for Standardization) is a worl

13、dwide 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 represented on

14、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.The procedures used to develop this do

15、cument 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 document was drafted in accordance with the editorial rules of the ISO/IEC Direct

16、ives, 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 such patent rights. Details of any patent rights identified during the developm

17、ent 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 not constitute an endorsement.For an explanation on the meaning of ISO spec

18、ific 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.iso.org/iso/foreword.html.The committee responsible for this document is ISO/T

19、C 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This third edition cancels and replaces the second edition (ISO 15675:2009), which has been technically revised.iv ISO 2016 All rights reservedBS ISO 15675:2016INTERNATIONAL STANDARD ISO 15675:2016(E)C

20、ardiovascular implants and artificial organs Cardiopulmonary bypass systems Arterial blood line filters1 ScopeThis document specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and

21、gaseous material from the blood of humans during cardiopulmonary bypass surgery.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. F

22、or undated references, the latest edition of the referenced document (including any amendments) applies.ISO 594-2, Conical fittings 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: Evalu

23、ation and testing within a risk management processISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interaction with bloodISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residualsISO 10993-11, Biological evaluation of medi

24、cal 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 products Radiation Part 1: Requirem

25、ents 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 for terminally sterilized medica

26、l 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 control of a sterilization process for medical devicesISO

27、 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 terms and definitions apply.ISO and IEC maintain t

28、erminological 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 15675:2016ISO 15675:2016(E)3.1arterial blood line filteracce

29、ssory device used as part of the cardiopulmonary bypass system in the arterial blood return line for filtering particles such as blood clots, debris and gas emboli from the blood3.2blood pathwaypaths of the arterial blood line filter (3.1) containing blood during its intended clinical use3.3blood ce

30、ll damageloss or destruction of cellular components of the blood components3.4platelet reductionpercentage reduction of platelets contained in a circuit, as a function of time3.5plasma-free haemoglobin leveldifference between the concentration of plasma-free haemoglobin in a circuit, as a function o

31、f time3.5.1normalized index of hemolysisNIHgrams of plasma-free hemoglobin released after pumping 100 l of bloodNIHg LfHb VHctQT/100100100100=wherefHb 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);

32、Hct is the hematocrit (%);T is the sampling time interval (min)3.6white blood cell reductionpercentage reduction of white blood cells contained in a circuit, as a function of time3.7filtration efficiencyability of the filter to remove particles from the simulated blood suspension test fluid, express

33、ed as a percentage3.8blood analoguetest solution which simulates blood viscosity between 2,0 103Pas (2,0 cP), to 3,5 103Pas (3,5 cP)3.9bubble eliminatordevice that can remove bubbles2 ISO 2016 All rights reservedBS ISO 15675:2016ISO 15675:2016(E)3.10predicate arterial filtersimilar arterial filter t

34、o the test arterial filter that has previously been approved and used for the 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 Bi

35、ocompatibilityThe 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 characteristics4.2.1 Blood pathway integrityWhen tested in accordance with 5.3.1, the blood pathway shall not leak.4.2.2 Blood vo

36、lumeThe 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, when tested in accordance with 5.3.3, allow a secure connection. Connection for accessory ports shall meet the requirements

37、 of ISO 594-2.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 satisfactory.NOTE 2 Connectors corresponding to ISO 86

38、37:2010, 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 percentage change (positive or negative) of plasma-free haemoglobin, platelets, and white blood cells, shall be within the r

39、ange of values specified by the manufacturer.The hemolysis results shall be reported as mg/dL and NIH.4.3.2 Filtration efficiencyWhen tested in accordance with 5.4.2, the filtration efficiency of any individual filter shall be at least 80 % when tested with particles that are 20 % larger than the no

40、minal pore size of the filter. ISO 2016 All rights reserved 3BS ISO 15675:2016ISO 15675:2016(E)4.3.3 Flow rate capacityWhen tested in accordance with 5.4.3, test results will demonstrate the flow rate and pressure limitation(s) to ensure safe and effective performance, as specified by the manufactur

41、er.4.3.4 Shelf lifeWhen tested in accordance with 5.4.4, test results shall demonstrate the rated shelf life, as specified by the manufacturer.4.3.5 Air-handling capabilityWhen tested in accordance with 5.4.5, test results shall demonstrate the air-handling capability, as specified by the manufactur

42、er.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 Operating variables shall be tho

43、se 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 nonlinear, sufficient determinations shall be made to permit valid interpolation betw

44、een 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 non-pyrogenicityCompliance shal

45、l be verified by inspection of the manufacturers documentation on sterilization and pyrogen testing, in accordance with ISO 17665-1, ISO 11135, 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 manufacturers docum

46、entation 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 pathway integrity (sterile final assembly)Fill the blood pathway of the device with water and subject it to a positive pressure of 1,5 the manuf

47、acturers rated pressure or, if none is given, to a pressure of 152 kPa (22 psi) gauge and maintain the pressure for 6 h or for the intended time of use specified by the manufacturer. Visually inspect the device for evidence of water leakage.4 ISO 2016 All rights reservedBS ISO 15675:2016ISO 15675:20

48、16(E)5.3.2 Blood volumeThe test liquid shall be anticoagulated whole blood or water.The volume of the blood pathway shall be determined as specified by the manufacturer.5.3.3 ConnectorsThe connection shall be made in accordance with the manufacturers instructions for use.The connection shall withsta

49、nd a pull force of 15 N for 15 s without separating.5.4 Performance characteristics5.4.1 Blood cell damage5.4.1.1 Test mediaThe test liquid for the blood pathway shall be heparinized blood.5.4.1.2 ProcedureTwo sets of appropriate, identical circuit components, including a pump, connecting tubing, a reservoir (as specified by the manufacturer and of suitable size relative to the device under test), and a heat exchanger, shall be assembled. The device under test shall be placed in one