1、BS ISO 15676:2016Cardiovascular implantsand artificial organs Requirements for single-use tubing packs forcardiopulmonary bypass andextracorporeal membraneoxygenation (ECMO)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 15676:2016 BRITISH STANDARDNational for
2、ewordThis British Standard is the UK implementation of ISO 15676:2016.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 n
3、ot 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 88275 3ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obli
4、gations.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 15676:2016 ISO 2016Cardiovascular implants and artificial organs Requirements for single-us
5、e tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)Implants cardiovasculaires et organes artificiels Exigences pour les paquets de tubes usage unique pour pontage cardiopulmonaire et oxygnation des membranes extracorporellesINTERNATIONAL STANDARDISO15676Second ed
6、ition2016-08-15Reference numberISO 15676:2016(E)BS ISO 15676:2016ISO 15676:2016(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
7、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 requester.ISO copyright officeCh. de Blandon
8、net 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 15676:2016ISO 15676:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 Requirements 34.1 Biological characteristics . 34.1.1 Sterili
9、ty and non-pyrogenicity . 34.1.2 Biocompatibility . 34.2 Physical characteristics . 34.2.1 General 34.2.2 Dimensions . 34.2.3 Material properties 34.3 Performance characteristics 34.3.1 Priming volume . 34.3.2 Life to failure testing . 44.3.3 Spallation 44.3.4 Shelf life . 45 Tests and measurements
10、. 45.1 General . 45.2 Biological characteristics . 45.2.1 Sterility and non-pyrogenicity . 45.2.2 Biocompatibility . 45.3 Physical characteristics . 55.3.1 Blood pathway integrity 55.3.2 Connections 55.3.3 Tubing material property testing 55.4 Performance characteristics 55.4.1 Tubing life 55.4.2 Sp
11、allation in tubing used in roller pumps 55.4.3 Shelf life . 66 Information supplied by the manufacturer . 66.1 Information on the tubing pack 66.1.1 Information on the unit container 66.1.2 Information on the shipping container 66.2 Information on the accompanying documents . 76.3 Information in the
12、 accompanying documents in a prominent form 76.4 Information to be provided by manufacturer upon request . 77 Packaging . 7Bibliography 8 ISO 2016 All rights reserved iiiContents PageBS ISO 15676:2016ISO 15676:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide fed
13、eration 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 that comm
14、ittee. 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 document an
15、d 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 Directives, Par
16、t 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 development of th
17、e 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 specific term
18、s 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/TC 150, Im
19、plants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.This second edition cancels and replaces the first edition (ISO 15676:2005), which has been technically revised.iv ISO 2016 All rights reservedBS ISO 15676:2016ISO 15676:2016(E)IntroductionThe intent of this do
20、cument is to ensure that medical grade tubing in single-use tubing packs for the transfer of blood and fluid during the period of cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) is adequately tested for both safety and function. The user commonly provides the specificatio
21、ns for the tubing pack. Furthermore, the purpose of this document is to ensure that the tubing pack characteristics be appropriately disclosed in the labelling and manufacturing information package. Tubing performance characteristics are specifically addressed within the context of this document as
22、a component part of a single-use tubing pack.This document therefore contains recommended procedures to evaluate such medical grade tubing intended for use during CPB procedures and ECMO. Test procedures to determine the material characteristics, the useful life of the tubing when used in a roller p
23、ump, and cleanliness are described. The limits for these characteristics are not specified.This document also includes minimum reporting requirements. Ready identification of the performance characteristics should assist the user in the selection of such medical grade tubing for the procedure approp
24、riate to the patient and procedure. This information may be useful in a clinics quality control process that aims to improve the safety of CPB and ECMO procedures.This document makes reference to other International Standards, which references methods for the determination of characteristics common
25、to medical devices.Requirements for animal and clinical studies are not included in this document. Such studies, however, may be part of a manufacturers quality system.This document contains only those requirements that are specific to such medical grade tubing for use during CPB and ECMO. Non-speci
26、fic requirements are covered by reference to other International Standards listed in the Normative References section. ISO 2016 All rights reserved vBS ISO 15676:2016BS ISO 15676:2016Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and
27、 extracorporeal membrane oxygenation (ECMO)1 ScopeThis document specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorpor
28、eal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. 24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as “sterile”.Thi
29、s document is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.2 Normative referencesThe following documents are referred to in the text in such a way
30、 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 34-1, Rubber, vulcanized or thermoplastic Determination of
31、tear strength Part 1: Trouser, angle and crescent test piecesISO 527-1, Plastics Determination of tensile properties Part 1: General principlesISO 9352, Plastics Determination of resistance to wear by abrasive wheelsISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing
32、 within a risk management processISO 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 17665-1, Sterilization of health care products Moist heat Part 1: Requir
33、ements for the development, validation and routine control of a sterilization process for medical devicesISO 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, Sterili
34、zation of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization doseISO 11607-1, Packaging for terminally st
35、erilized 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 processesINTERNATIONAL STANDARD ISO 15676:2016(E) ISO 2016 All
36、rights reserved 1BS ISO 15676:2016ISO 15676:2016(E)ISO 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 devicesASTM D792-00, Standard test methods f
37、or density and specific gravity (relatively density) of plastics by displacementASTM D2240-04, Standard test method for rubber property Durometer hardness3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.ISO and IEC maintain terminological databases
38、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/3.1durometer hardnessmeasure of hardness of elastic materials by Shore A range3.2elongationincrease in linear dimension3.3
39、tensile strengthforce per unit of original cross section on elongation (3.2) to rupture3.4tear strengthmeasure of stress needed to continue rupturing a sheet of rubber or plastic, usually after an initial cut3.5tubing packconsists of tubing sections joined by extracorporeal connectors and/or connect
40、ed to extracorporeal devices intended for CPB or ECMO applications3.6specific gravityratio of the mass of a body to the mass of an equal volume of water at 4 C3.7spallationphenomenon whereby particles dislodge from a surface under cyclical stress3.8brittle pointtemperature at which 50 % of test samp
41、les exhibit cracking or breakage after linear impact at a specified speed3.9blood analoguetest solution which simulates blood viscosity between 2,0 103Pas (2,0 cP) to 5,0 103Pas (5,0 cP)Note 1 to entry: The higher viscosity specified addresses conditions encountered during a range of clinical proced
42、ures specific to the tubing pack.2 ISO 2016 All rights reservedBS ISO 15676:2016ISO 15676:2016(E)4 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 Biocompat
43、ibilityAll parts of the tubing pack that may come in direct contact with the patients 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 GeneralWhen tested in accordance with 5.3.1, the blood
44、 pathway shall not leak.4.2.2 DimensionsThe dimensions of the tubing (e.g. inner diameter, wall thickness, segment lengths) shall conform to the specifications of the user.4.2.3 Material propertiesThe tubing material shall be tested or specified by the manufacturer or extruder to determine that the
45、material properties listed in this subclause conform to the manufacturers specifications as reported in 6.4 b). Upon request, the manufacturer should make them available in a technical data sheet. The material properties include the following:a) durometer hardness;b) ultimate elongation;c) tensile s
46、trength;d) brittle point;e) specific gravity;f) tear strength.4.3 Performance characteristics4.3.1 Priming volumeThe priming volume shall be measured or calculated and reported in 6.2 e). Results shall indicate the priming volume over the entire range of tubing size provided by the manufacturer. Tes
47、ting shall be performed according to the manufacturers protocol.Some of these tests may be combined and performed at the same time. ISO 2016 All rights reserved 3BS ISO 15676:2016ISO 15676:2016(E)4.3.2 Life to failure testingThe labelled anticipated lifetime of the roller pump boot tubing should be
48、a figure not exceeding the lifetime of tubing as determined using the test specified in 5.4.1. The tubing shall be tested under the operating variables specified by the manufacturer in 6.2 c) for each available size and wall thicknesses of tubing. The results of these tests shall be reported as mean
49、 and standard deviation in 6.3 d).4.3.3 SpallationWhen tubing intended for use in a peristaltic pump is tested in accordance with 5.4.2, the spalled particles shall not exceed the level specified by the manufacturer.4.3.4 Shelf lifeWhen tested in accordance with 5.4.3, test results shall demonstrate the rated shelf life as specified by the manufacturer.5 Tests and measurements5.1 General5.1.1 Tests and measurements shall be performed with the device under test prepared according to the manufac
