《BS-ISO-15674-2001.pdf》由会员分享，可在线阅读，更多相关《BS-ISO-15674-2001.pdf（16页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS ISO 15674:2001 Cardiovascular implants and artificial organs Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags ICS 11.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffie
2、ldun, na, Sun Nov 26 02:51:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15674:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Commit
3、tee on 26 November 2001 BSI 26 November 2001 ISBN 0 580 38424 1 National foreword This British Standard reproduces verbatim ISO 15674:2001 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/23, Cardiovascular implants, dialy
4、sis systems and oxygenators, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in
5、the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are
6、responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and
7、 keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to iv, pages 1 to 9, and a back cover. The BSI copyright date displayed
8、in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISO 15674 First edition 2001-11-01 Reference numbe
9、r ISO 15674:2001(E) Cardiovascular implants and artificial organs Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags Implants cardiovasculaires et organes artificiels Systmes rservoirs de cardiotomie/veineux paroi dure (avec/sans filtre) et sacs rserv
10、oirs veineux mous Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15674:2001(E) ii This FDP feli amy ctnonia ededdebm tyfep.seca In aroccecnad tiwh Asebod gnisnecil ycilop, thsi feli may be pritnde ro eivwde but sllah ton eb tideed sseln
11、u teh tyfepseca hwich are mededdeb era licdesne to dna tsniladel on teh moctupre epfrromign the ideti.gn In odgnidaolnw this file, raptise ccatpe trehien teh serilibisnopty fo ton fnirignign sebodA gnisnecil ilopcy. The ISO tneCral Sceterarita catpecs no libaility in this aera. ebodA si a trmedarak
12、of Adebo Stsysme Irocntarop.de teDails of teh fostware prtcudos desu to crtaee tsih PFD feli nac be fdnuo ni the Glarene Info talerive to the f;eli teh PDF-taercnoi rapmateers weer tpodezimi for pritn.gni vErey cera sah eebn tkane to rusnee ttah the feli is tiusbael for ues by ISO mrebme seidob. In
13、teh kilnuley evtne ttah a pborlme talerign to ti si f,dnuo saelpe ifnrom teh tneClar Stercearita ta the serddas givne olebw. ISO 1002 llA rithgs rresev.de Unless torehiwse sficep,dei on rapt of tihs buptacilion may be rperdecudo ro tuilidez in any form ro by nay m,snae ele-c trinoc or m,lacinahce gn
14、idulcni tohppocoyign dna cimrfo,mli tiwtuoh repminoiss ni rwitgni fmor eitreh ISO at teh serddas olebw ro ISOs mme- reb ydob in the cuotnry fo the rtseuqeer. ISO cporythgi fofiec esaC tsopael 65 1121-HC Geneva 02 Te.l + 41 22 947 10 11 Fax + 14 22 479 09 47 E-liam copyrightsio.ch Web wwwsi.oc.h Prde
15、tni in Sztiwerldna Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15674:2001(E) diii ContentsPage 1Scope .1 2Normative references .1 3Terms and definitions 2 4Requirements .3 4.1Biological characteristics .3 4.2Physical characteristics
16、.3 4.3Performance characteristics 3 5Tests and measurements to determine compliance with this International Standard .4 5.1General 4 5.2Biological characteristics .5 5.3Physical characteristics .5 6Information supplied by the manufacturer 5 6.1Information to be given on the reservoir (labelling) .5
17、6.2Information to be given on the packaging 6 6.3Information to be given in the accompanying documents 6 6.4Information to be given in the accompanying documents in a prominent form 7 7Packaging .7 Annex AFactors to be considered in evaluating performance characteristics 8 Bibliography.9 Licensed Co
18、py: sheffieldun sheffieldun, na, Sun Nov 26 02:51:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15674:2001(E) iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Stand
19、ards 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 committee. International organizations, governmental and non-governmental, in liaison with ISO, also ta
20、ke part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted b
21、y the technical committees are circulated to the member bodies for voting. Publication as an International 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 International Standard may be the subjec
22、t of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 15674 was prepared by Technical Committee ISO/TC 150,Implants for surgery, Subcommittee SC 2,Cardiovascular implants. Annex A of this International Standard is for informat
23、ion only. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARDISO 15674:2001(E) d1 Cardiovascular implants and artificial organs Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir
24、 bags 1Scope ThisInternationalStandardspecifiesrequirementsforsterile,single-use,extracorporealhard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery. This International Standard applies only to
25、the blood reservoir aspects for multifunctional systems which may have integral components such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc. 2Normative references The following normative documents contain provisions which, through reference in this text, constit
26、ute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editio
27、ns of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 10993-1,Biological evaluation of medical devices Part 1: Evaluation and t
28、esting. ISO 10993-7,Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals. ISO 10993-11,Biological evaluation of medical devices Part 11: Tests for systemic toxicity. ISO 11134,Sterilization of health care products Requirements for validation and routine control Ind
29、ustrial moist heat sterilization. ISO 11135,Medical devices Validation and routine control of ethylene oxide sterilization. ISO 11137,Sterilization of health care products Requirements for validation and routine control Radiation sterilization. ISO 11607,Packaging for terminally sterilized medical d
30、evices. ISO 13485,Quality systems Medical devices Particular requirements for the application of ISO 9001. ISO 13488,Quality systems Medical devices Particular requirements for the application of ISO 9002. ISO 14937,Sterilization of health care products General requirements for characterization of a
31、 sterilizing agent and the development, validation and routine control of a sterilization process for medical devices. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15674:2001(E) 2 3Terms and definitions For the purposes of this Intern
32、ational Standard, the following terms and definitions apply. 3.1 hard-shell cardiotomy reservoir extracorporeal device consisting of rigid walls designed to collect, defoam and filter suctioned blood 3.2 hard-shell venous reservoir extracorporeal device consisting of rigid walls designed to collect
33、and defoam venous blood 3.3 soft-bag venous reservoir extracorporeal device consisting of collapsible, pliable walls designed to collect venous blood 3.4 hard-shell cardiotomy/venous reservoir system extracorporeal device designed to function simultaneously as both a venous reservoir and cardiotomy
34、reservoir 3.5 blood-gas exchanger oxygenator extracorporeal device designed to supplement, or be a substitute for, the respiratory function of the lung 3.6 blood ?referring to a fluid used in testing? heparinized human or bovine blood, whole or diluted with physiological saline solution 3.7 integral
35、 part part that is connected to the reservoir or is part of the reservoir system and that cannot normally be separated by the user 3.8 operating variable setting of controls which affects the function of the device 3.9 hold-up volume volume present in the device during passage of fluid through the d
36、evice NOTEThis volume may vary with the flow rate and other factors. 3.10 break-through volume volume 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 device 3.11 sealed hard-shell reservoir hard
37、-shell reservoir that may be operated at either positive or negative pressure 3.12 priming volume volume of fluid required to fill the filter Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15674:2001(E) d3 4Requirements 4.1Biological ch
38、aracteristics 4.1.1Sterility and non-pyrogenicity The blood pathway shall be sterile and non-pyrogenic. Compliance shall be verified in accordance with 5.2.1. 4.1.2Biocompatibility Parts of the blood pathway shall be biocompatible with respect to their intended use. Compliance shall be verified in a
39、ccordance with 5.2.2. 4.2Physical characteristics 4.2.1General When tested in accordance with 5.3.1 and 5.3.2, the blood pathway shall not leak. 4.2.2Blood volumes The volume of the blood pathway shall be within the tolerance specified by the manufacturer see 6.3 k). 4.2.3Connectors Connectors for c
40、onnection to the blood pathway shall, when tested in accordance with 5.3.4, allow a secure connection. NOTE 1Connectors of a type that allows connection of tubes with an inside diameter of,or, or a type that complies with Figure 1 of ISO 8637:1989, or a type that complies with ISO 594-2 have been us
41、ed. NOTE 2Connectors corresponding to Figure 3 of ISO 8637:1989 are considered as one way to comply with this requirement. 4.3Performance characteristics 4.3.1Cell damage Testing to determine the amount of cell damage generated during use of the device shall be conducted at maximum flowrates and the
42、 results presented in accordance with item 6.3 p). Testing shall be over the specified time of operation or. The testing shall be conducted according to the manufacturers protocols. 4.3.2Air-handling capacity Testing to demonstrate the air-handling characteristics shall be conducted at various flowr
43、ates and the results presented as in 6.3 p). The test shall be conducted according to the manufacturers protocols. 4,8 mm 6,3 mm 9,5 mm12,7 mm 6 h Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 15674:2001(E) 4 4.3.3Priming volume of the
44、 filters (where applicable) The volume of the filter(s) shall be determined and the results presented as in 6.3 o). Testing shall be conducted according to the manufacturers protocols. 4.3.4Defoaming characteristics Where applicable the defoaming characteristics shall be determined and reported as i
45、n 6.3 p). The testing shall be conducted according to the manufacturers protocols. 4.3.5Volume calibration The accuracy of the volume markings shall be measured and tolerances shall be presented as required in 6.3 n). 4.3.6Filtration efficiency The efficiency of the filter shall be determined by the
46、 manufacturer according to their protocol. The filter efficiency shall be reported as in 6.3 p). The testing shall be performed around the anticipated flow range of the filter. 4.3.7Break-through volume The break-through volume shall be measured and reported as in 6.3 p). The testing shall be perfor
47、med according to the manufacturers protocol. 4.3.8Dynamic priming volume The dynamic priming volume shall be measured and reported as in 6.3 k). Results shall indicate the priming volume over the entire range of flows specified by the manufacturer. Testing shall be performed according to the manufac
48、turers protocol. NOTE 1Guidance for testing is given in annex A. NOTE 2Some of these tests may be combined and performed at the same time. 5Tests and measurements to determine compliance with this International Standard 5.1General 5.1.1Tests and measurements shall be performed with the device under
49、test prepared according to the manufacturers instructions for intended clinical use. 5.1.2Operating variables shall be those specified by the manufacturer for intended clinical use unless otherwise specified. 5.1.3Unless otherwise stated, the temperature of test liquids shall be. 5.1.4If the relationship between variables is non-linear, sufficient determinations shall be made to permit valid interpolation between data points. 5.1.5The test or measurement procedures shall be regarded as reference procedures. Other procedures can be a