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1、INTERNATIONAL STANDARD ISO 15676 First edition 2005-07-15 Reference number ISO 15676:2005(E) ISO 2005 Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) Implants cardiovasculaires et organes
2、 artificiels Exigences pour les paquets de tubes usage unique pour pontage cardiopulmonaire et oxygnation des membranes extracorporelles Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/2
3、1/2007 10:56:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15676:2005(E) ii ISO 2005 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edi
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6、dies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechani
7、cal, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.o
8、rg Published in Switzerland Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 10:56:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15676:2005(E) I
9、SO 2005 All rights reserved iii Foreword ISO (the International Organization for Standardization) 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 inter
10、ested 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 work. ISO collaborates closely with the International Electrotechnical
11、 Commission (IEC) on all matters of electrotechnical standardization. International Standards 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 te
12、chnical 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 document may be the subject of patent rights. IS
13、O shall not be held responsible for identifying any or all such patent rights. ISO 15676 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems. Copyright International Organization for Standardization Provided by I
14、HS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 10:56:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15676:2005(E) iv ISO 2005 All rights reserved Introduction The intent of this International Standard is to ensure
15、 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 specifications for the tubing p
16、ack. Furthermore, the purpose of this International Standard 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 International Sta
17、ndard as a component part of a single-use tubing pack. This International Standard 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
18、 when used in a roller pump, and cleanliness are described. The limits for these characteristics are not specified. This International Standard also includes minimum reporting requirements. Ready identification of the performance characteristics should assist the user in the selection of such medica
19、l grade tubing for the procedure appropriate 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 International Standard makes reference to other International Standards, which references me
20、thods for the determination of characteristics common to medical devices. Requirements for animal and clinical studies are not included in this International Standard. Such studies, however, may be part of a manufacturers quality system. This International Standard contains only those requirements t
21、hat are specific to such medical grade tubing for use during CPB and ECMO. Non-specific requirements are covered by reference to other International Standards listed in the Normative References section. Copyright International Organization for Standardization Provided by IHS under license with ISO L
22、icensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 10:56:00 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARDISO 15676:2005(E) ISO 2005 All rights reserved 1 Cardiovascular implants and artificial organs Requirements for single-use
23、 tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) 1Scope This International Standard specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This International Standard is applicable to all me
24、dical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short- term, i.e. duration) CPB surgery, or (long-term, i.e. ) ECMO procedures. The st
25、erility and non- pyrogenicity provisions of this International Standard are applicable to tubing packs labelled as “sterile”. This International Standard is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators),
26、 reservoirs, blood filters, defoamers, blood pumps, etc. 2Normative references The 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 (inclu
27、ding any amendments) applies. ISO 34-1, Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces ISO 527-1, Plastics Determination of tensile properties Part 1: General principles ISO 9352, Plastics Determination of resistance to wear by abra
28、sive wheels ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing 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,
29、 Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization ISO 11135, Sterilization of health care products Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices ISO 1
30、1137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose ISO 11607-1, Packaging
31、for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems 24 h Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 1
32、0:56:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15676:2005(E) 2 ISO 2005 All rights reserved ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Requirements for forming, sealing and assembly processes ISO 14937, Sterilization of health care
33、 products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ASTM D792-00, Standard test methods for density and specific gravity (relatively density) of plastics by displacement ASTM D10
34、44-99, Standard test method for resistance of transparent plastics to surface abrasion ASTM D2240-04, Standard test method for rubber property Durometer hardness 3Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 durometer hardness measure of har
35、dness of elastic materials by Shore A range 3.2 elongation increase in linear dimension 3.3 tensile strength force per unit of original cross section on elongation to rupture 3.4 tear strength measure of stress needed to continue rupturing a sheet of rubber or plastic, usually after an initial cut 3
36、.5 tubing pack consists of tubing sections joined by extracorporeal connectors and/or connected to extracorporeal devices intended for CPB or ECMO applications 3.6 specific gravity ratio of the mass of a body to the mass of an equal volume of water at 3.7 spallation phenomenon whereby particles disl
37、odge from a surface under cyclical stress 3.8 brittle point temperature at which of test samples exhibit cracking or breakage after linear impact at a specified speed 4 C 50 % Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Stan
38、dards 1/9972545001 Not for Resale, 04/21/2007 10:56:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15676:2005(E) ISO 2005 All rights reserved 3 4Requirements 4.1Biological characteristics 4.1.1Sterility and non-pyrogenicity The blood pathway shall be sterile and non
39、-pyrogenic. Compliance shall be verified in accordance with 5.2.1. 4.1.2Biocompatibility All 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. 4.2P
40、hysical characteristics 4.2.1General When tested in accordance with 5.3.1, the blood pathway shall not leak. 4.2.2Dimensions The dimensions of the tubing (e.g. inner diameter wall thickness, segment lengths) shall conform to the specifications of the user. 4.2.3Material properties The tubing shall b
41、e tested by the manufacturer or extruder to determine that the material properties listed in this subclause conform to the manufacturers specifications as reported in 6.4 b). These tests shall be conducted using standard test methods as provided in 5.3.3. Upon request, the manufacturer should make t
42、hem available in a technical data sheet. The material properties include: a)durometer hardness; b)ultimate elongation; c)tensile strength; d)brittle point; e)specific gravity; f)tear strength. 4.3Performance characteristics 4.3.1Priming volume The priming volume shall be measured or calculated and r
43、eported in 6.2 e). Results shall indicate the priming volume over the entire range of tubing size provided by the manufacturer. Testing shall be performed according to the manufacturers protocol. Some of these tests may be combined and performed at the same time. Copyright International Organization
44、 for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 10:56:00 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15676:2005(E) 4 ISO 2005 All rights reserved 4.3.2Life to failure testing The l
45、abelled anticipated lifetime of the roller pump boot tubing should be 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 thick
46、nesses of tubing. The results of these tests shall be reported as mean and standard deviation in 6.3 d). 4.3.3Spallation When 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 for an period
47、 in 6.4 c). A measurement shall be taken at , and again at , to model early and late onset of spallation. 5Tests and measurements 5.1General 5.1.1Tests and measurements shall be performed with the device under test prepared according to the manufacturers instructions for intended clinical use. 5.1.2
48、Operating variables shall be those specified by the manufacturer for intended clinical use unless otherwise specified. 5.1.3According to the intended use of the tubing, the temperature of test liquids shall be , and to reflect typical and extreme use conditions. 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 are to be regarded as reference procedures. Other