ISO 19001 INTERNATIONAL STANDARD Second edition 2013-03-15 In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology Dispositifsmedicauxdediagnosticinvitro-Informationsfournies par le fabricant avec les réactifsde coloration dediagnostic in vitro utilisés en biologie ERIE SO ISORebwence o43(ey Copyright Intermational Organization for Standardizatior Notfor @IS02013 IS019001:2013(E) COPYRIGHTPROTECTEDDOCUMENT @IS0 2013 AHbyghty raeansedlalestronicotherwipemifiedlaniclaindfiutdisgpplbbicatbpyimgyoltqnstihgintprndtioedntnttiaet) otimeamyisewithout prior written permission. Permission can be requested from either ISO at the address below or Iso's member body in the country of the requester. SSeostltght officeCH-1211 Geneva 20 Tel. + 4f22749 01 11 Fax + 4122 749 09 47 [email protected] Published in Switzerland Copyrightntemafinal OrganizationforStandardization University of Alt 4001, User=sharabiani, shahramfs No reproductio networking permited without license from IHS IS0 19001:2013(E) Contents Page Foreword iv Iptroduction. Scope 1 2 Normative references 1 3 Terms anddefinitions 1 4 Requirements for information supplied by the manufacturer 3 4.1 Generalrequirements 4.2 Additional requirements for specific kinds of reagent. Annex (informative) biologicalinformationprocedures Bibliography 13 Copyright Intemational Organization for Standardization IHS under lic iii IS0 19001:2013(E) Foreword Iso (the International Organizationfor Standardization) is a worldwide federation of national standards thudiegh(IsO tectmicet boabiasjtahsewofkf ptepbreingbodyInitteresitedailhStandebjdsti sonowhidhycarrtiechaital committeehas been established has the rightto 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 electrotechnical standardization. International Electrotechnical Commission (IEC) on all matters of International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. 3tanmainstaak pfedbechnical terhnifabescommitteesprepare Intirsidetetal Starfthar aembarBrafernatfon xpting. Publication as an International Standard requires approval by atleast 75 % of the member bodies casting a vote. Aatentionrights.tfawrtshthf hetpeksibilflyaespfsibltherelaerAitsifgangltisichdeatereht mayrights.the subject of IS019001waspreparedbyTechnicalCommitteeIS0/TC212,Clinical laboratorytestingand invitro diagnostictestsystems. This second editioncancels andreplaces thefirst edition (I019001:2002), whichhas been technically revised. Copyright Intem hational Organization for Standardizatio lotforR IS019001:2013(E) Introduction with it. intendedconstitutethemanufacturersjustificationand requirements stains, chromogenic reagentsinformationis Covriahbiylemalinal Orgenizatin for Standardization No reproduction or networking perited without license from IHS ot for Resale, 11/30/2013 22:26:57 MST This International Standard relates to IS0 18113-1 and IS0 18113-2, which can be used in conjunction The use of reagents required for staining in biology as well as the specific examples of information supplied by the manufacturer for two staining procedures as provided in Annex A are based ona European consensus; they suppliersforthevendors of dyes,listed Clause 4. This assist scientific and other reagents used for staining in biology in complying with the required specific product data. V @ IS0 2013 - All rights reserved S6844001, User=sharabiani, shahramfs Noreroductionrnetwoking eitedwhou icenefrmH