Dansk standard DS/ISO 15675 2. udgave 2009-06-02 Kardiovaskulære implantater og kunstige organer Systemer til kardiopulmonær bypass Filtre til arterielt blod Cardiovascular implants and artificial organs Cardiopulmonary bypass systems Arterial blood line filters
DS/ISO 15675 København DS projekt: M229621 ICS: 11.040.40 Første del af denne publikations betegnelse er: DS/ISO, hvilket betyder, at det er en international standard, der har status som dansk standard Denne publikations overensstemmelse er: IDT med: ISO 15675:2009. DS-publikationen er på engelsk. Denne publikation erstatter: DS/ISO 15675:2002. DS-publikationstyper Dansk Standard udgiver forskellige publikationstyper. Typen på denne publikation fremgår af forsiden. Der kan være tale om: Dansk standard standard, der er udarbejdet på nationalt niveau, eller som er baseret på et andet lands nationale standard, eller standard, der er udarbejdet på internationalt og/eller europæisk niveau, og som har fået status som dansk standard DS-information publikation, der er udarbejdet på nationalt niveau, og som ikke har opnået status som standard, eller publikation, der er udarbejdet på internationalt og/eller europæisk niveau, og som ikke har fået status som standard, fx en teknisk rapport, eller europæisk præstandard DS-håndbog samling af standarder, eventuelt suppleret med informativt materiale DS-hæfte publikation med informativt materiale Til disse publikationstyper kan endvidere udgives tillæg og rettelsesblade DS-publikationsform Publikationstyperne udgives i forskellig form som henholdsvis fuldtekstpublikation (publikationen er trykt i sin helhed) godkendelsesblad (publikationen leveres i kopi med et trykt DS-omslag) elektronisk (publikationen leveres på et elektronisk medie) DS-betegnelse Alle DS-publikationers betegnelse begynder med DS efterfulgt af et eller flere præfikser og et nr., fx DS 383, DS/EN 5414 osv. Hvis der efter nr. er angivet et A eller Cor, betyder det, enten at det er et tillæg eller et rettelsesblad til hovedstandarden, eller at det er indført i hovedstandarden. DS-betegnelse angives på forsiden. Overensstemmelse med anden publikation: Overensstemmelse kan enten være IDT, EQV, NEQ eller MOD IDT: Når publikationen er identisk med en given publikation. EQV: Når publikationen teknisk er i overensstemmelse med en given publikation, men præsentationen er ændret. NEQ: Når publikationen teknisk eller præsentationsmæssigt ikke er i overensstemmelse med en given standard, men udarbejdet på baggrund af denne. MOD: Når publikationen er modificeret i forhold til en given publikation.
INTERNATIONAL STANDARD ISO 15675 Second edition 2009-04-15 Cardiovascular implants and artificial organs Cardiopulmonary bypass systems Arterial blood line filters Implants cardiovasculaires et organes artificiels Systèmes de pontage cardio-pulmonaire Filtres en ligne pour sang artériel Reference number ISO 15675:2009(E) ISO 2009
ISO 15675:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2009 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 mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's 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 copyright@iso.org Web www.iso.org Published in Switzerland ii ISO 2009 All rights reserved
ISO 15675:2009(E) Contents Page Foreword... iv 1 Scope... 1 2 Normative references... 1 3 Terms and definitions... 1 4 Requirements... 2 4.1 Biological characteristics... 2 4.2 Physical characteristics... 2 4.3 Performance characteristics... 3 5 Tests and measurements to determine compliance with this International Standard... 3 5.1 General... 3 5.2 Biological characteristics... 4 5.3 Physical characteristics... 4 5.4 Performance characteristics... 4 6 Information supplied by the manufacturer... 6 6.1 Information to be given on the arterial blood line filter... 6 6.2 Information to be given on the packaging... 6 6.3 Information to be given in the accompanying documents... 7 6.4 Information to be given in the accompanying documents in a prominent form... 8 7 Packaging... 8 Bibliography... 9 ISO 2009 All rights reserved iii
ISO 15675:2009(E) 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 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 take 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 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 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. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15675 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems. This second edition cancels and replaces the first edition (ISO 15675:2001), which has been technically revised. iv ISO 2009 All rights reserved
INTERNATIONAL STANDARD ISO 15675:2009(E) Cardiovascular implants and artificial organs Cardiopulmonary bypass systems Arterial blood line filters 1 Scope This International Standard 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 gaseous material from the blood of humans during cardiopulmonary bypass surgery. 2 Normative 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 (including any amendments) applies. ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings 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 11135:1994, Medical devices Validation and routine control of ethylene oxide sterilization ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes 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 ISO 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 devices 3 Terms and definitions For the purposes of this document, the following terms and definitions apply: 3.1 arterial blood line filter accessory 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 blood ISO 2009 All rights reserved 1