CAN CSA-Z900 2 4-2012 Ocular tissues for transplantation (Second Edition Update No 1 April 2013 Update No 2 August 2015 Reprinted August 2015).pdf

1、CAN/CSA-Z900.2.4-12A National Standard of CanadaOcular tissues for transplantationReprinted August 2015. This reprint is being issued to incorporate Updates into the original 2012 Standard. Changes are marked by the delta () symbol.Legal Notice for StandardsCanadian Standards Association (operating

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18、the latest edition from the SDO which publishes the standard.The responsibility for approving standards as National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en fran

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20、yStandards Council of CanadaTMA trade-mark of the Canadian Standards Association, operating as “CSA Group”National Standard of CanadaPublished in December 2012 by CSA GroupA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416

21、747-4044Visit our Online Store at shop.csa.caCAN/CSA-Z900.2.4-12Ocular tissues for transplantationPrepared byISBN 978-1-55491-941-3 2012 CSA Group. Reprinted with revisions August 2015.All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permis

22、sion of the publisher.To purchase standards and related publications, visit our Online Store at shop.csa.ca or call toll-free 1-800-463-6727 or 416-747-4044.December 2012 iiiContents 2012 CSA Group Ocular tissues for transplantationTechnical Committee on Safety of Cells, Tissues, and Organs for Tran

23、splantation and Assisted Reproduction viSubcommittee on Ocular Tissues viiiPreface ix1Scope 12 Reference publication 23 Definitions and abbreviations 23.1 Definitions 23.2 Abbreviations 24 Establishment requirements 24.1 Establishment identity 24.2 Personnel 24.2.1 General 24.2.2 Training 34.2.3 Med

24、ical and scientific directors 34.2.4 Technical staff 34.3 Quality management 44.4 Satellite laboratories 45 Facilities 45.1 General 45.2 Security 45.3 Equipment 45.4 Eye bank laboratory 56 Standard operating procedures (SOPs) 56.1 General 56.2 Format 56.3 Content 56.4 Approvals and reviews 66.5 Extr

25、a copies 66.6 Archives 67 Records and tracking 67.1 General 67.2 Donor identification 67.3 Recordkeeping 67.4 Tracking 67.5 Minimum information to be retained 77.5.1 Donor and recipient information 77.5.2 Recipient follow-up information 78 Infection control and safety 79 Disposal of tissues 8CAN/CSA

26、Z900.2.4-12 2012 CSA Groupiv December 201210 Consent 811 Compensation 812 Donor suitability assessment 812.1 General 812.2 Suitability of donors 812.2.1 General 812.2.2 Donor age 812.2.3 Assessment of living donors 812.3 Documentation 813 Donor screening 913.1 Contraindications or exclusion criteri

27、a 913.1.1 General 913.1.2 Use of contraindicated ocular tissues 913.1.3 Exclusion criteria for ocular tissues 913.1.4 Penetrating keratoplasty 913.1.5 Lamellar grafts 1013.1.6 Scleral tissue 1113.2 Physical examination 1113.3 West Nile virus 1114 Testing 1114.1 General 1114.2 Laboratory testing 1114

28、2.1 General 1114.2.2 Gross examination 1114.2.3 Slit-lamp examination 1114.2.4 Specular microscopy 1214.2.5 Microbiological culturing 1215 Retrieval, preservation, and storage 1215.1 General 1215.2 Reagents and supplies 1215.3 Retrieval 1315.3.1 General 1315.3.2 Time intervals 1315.3.3 Recording of

29、 time intervals 1315.3.4 Enucleation procedure 1315.3.5 In situ and laboratory removal of the corneal scleral rim 1315.4 Preparation and preservation 1415.4.1 General 1415.4.2 Short- and intermediate-term preservation 1415.4.3 Long-term preservation 1415.4.4 Whole globe preservation 1415.4.5 Scleral

30、 preservation 1415.5 Pooling 1515.6 Packaging and storage 1516 Labels, package inserts, and accompanying documentation 1516.1 General 1516.2 Documentation 1516.3 Label information 15 2012 CSA Group Ocular tissues for transplantationDecember 2012 v16.3.1 General 1516.3.2 Labels 1616.3.3 Package inser

31、ts 1616.4 Forms 1616.5 Nonsurgical donor tissue 1717 Quarantine and release 1718 Distribution 1718.1 General 1718.2 Transportation 1718.3 Receiver of ocular tissue 1818.4 Exceptional distribution 1819 Error, accident, and adverse reaction investigation and reporting 1820 Continuous improvement 18CAN

32、/CSA-Z900.2.4-12 2012 CSA Groupvi December 2012Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted ReproductionM. Germain Hma-Qubec,Sainte-Foy, QubecChairF. Agbanyo Health Canada, Centre for Blood and Tissues Evaluation,Ottawa, OntarioVice-ChairH. Messner The

33、 Princess Margaret Hospital, Toronto, OntarioVice-ChairC. Beninger Southern Alberta Organ and Tissue Program,Calgary, AlbertaRepresenting the Canadian Society of TransplantationJ. Biemans Canadian Blood Services,Ottawa, OntarioAssociateP. Chaudhury McGill University Health Centre,Montral, QubecRepre

34、senting the Canadian Society of TransplantationAssociateM. Fortin Hpital Notre Dame du Centre Hospitalier Universit de Montral,Montral, QubecRepresenting BioethicistsL.A. Gillham-Eisen Health Canada,Office of Policy and International Collaboration,Ottawa, OntarioM. Gross Queen Elizabeth II Health Sc

35、iences Centre,Halifax, Nova ScotiaJ. Hanright Trillium Gift of Life Network,Toronto, OntarioY. Jalbert Ministre de la Sant et des Services Sociaux (MSSS),Qubec, QubecD. Kumar University of Alberta, Edmonton, AlbertaRepresenting the Association of Medical Microbiology and Infectious Disease Canada (A

36、MMI) 2012 CSA Group Ocular tissues for transplantationDecember 2012 viiM. Larivire Transplant Qubec, Montral, QubecA. Leader Ottawa Fertility Centre, Ottawa, OntarioR. Lundrigan Kidney Foundation of Canada,Spaniards Bay, Newfoundland and LabradorConsumer RepresentativeAssociateG. Nayeri Health Canad

37、a,Health Products and Food Branch,Ottawa, OntarioK. Peltekian Queen Elizabeth II Health Sciences Centre,Halifax, Nova ScotiaAssociateK. Reinhard Health Canada,Assisted Human Reproduction Implementation Office,Ottawa, OntarioAssociateS. Rmy Hma-Qubec, Saint-Laurent, QubecAssociateR. Rennie University

38、 of Alberta Hospital, Edmonton, AlbertaLiaison representing CSA TC Z252 and the Canadian Advisory Committee to ISO/TC212AssociateG. Rocha GRMC Vision Centre, Brandon, ManitobaK. Young Canadian Blood Services, Edmonton, AlbertaJ. Kraegel CSA Group,Mississauga, OntarioProject ManagerCAN/CSA-Z900.2.4-1

39、2 2012 CSA Groupviii December 2012Subcommittee on Ocular TissuesG. Rocha GRMC Vision Centre, Brandon, ManitobaChairT. Demong Demong Associate Eye Centre,Calgary, AlbertaP. Derksen Canadian Blood Services,Toronto, OntarioW. Dixon Sunnybrook Health Sciences Centre, Toronto, OntarioM. Ekins Winnipeg Cl

40、inic,Winnipeg, ManitobaM. Gatien New Brunswick Eye Bank,St. John, New BrunswickL.A. Gillham-Eisen Health Canada, Office of Policy and international Collaboration,Ottawa, OntarioP. Laughrea CHA, Hpital du Saint-Sacrement,Qubec, QubecC. Seamone Halifax, Nova ScotiaRepresenting the Canadian Ophthalmolo

41、gical SocietyA. Slomovic University Health Network Toronto, Western Hospital,Toronto, OntarioA. Vachon Hma-Qubec,St- Laurent, QubecJ. Kraegel CSA Group,Mississauga, OntarioProject Manager 2012 CSA Group Ocular tissues for transplantationDecember 2012 ixPrefaceThis is the second edition of CAN/CSA-Z9

42、00.2.4, Ocular tissues for transplantation. It supersedes the first edition published in 2003.This Standard is part of a series of management system standards related to the safety of cells, tissues, and organs for transplantation and assisted reproduction. It was developed from work initiated by He

43、alth Canadas Expert Working Group on Safety of Organs and Tissues for Transplantation.This Standard was prepared by the Subcommittee on Ocular Tissues, under the jurisdiction of the Technical Committee on Safety of Cells, Tissues, and Organs for Transplantation and Assisted Reproduction and the Stra

44、tegic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.Notes: (1) Use of the singular does not exclude the plural (and vice versa) when the sens

45、e allows.(2) Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.(3) This Standard was developed by consensus, which is defined

46、 by CSA Policy governing standardization Code of good practice for standardization as “substantial agreement. Consensus implies much more than a simple majority, but not necessarily unanimity”. It is consistent with this definition that a member may be included in the Technical Committee list and ye

47、t not be in full agreement with all clauses of this Standard.(4) To submit a request for interpretation of this Standard, please send the following information to inquiriescsagroup.org and include “Request for interpretation” in the subject line:(a) define the problem, making reference to the specif

48、ic clause, and, where appropriate, include an illustrative sketch;(b) provide an explanation of circumstances surrounding the actual field condition; and(c) where possible, phrase the request in such a way that a specific “yes” or “no” answer will address the issue.Committee interpretations are proc

49、essed in accordance with the CSA Directives and guidelines governing standardization and are available on the Current Standards Activities page at standardsactivities.csa.ca.(5) This Standard is subject to periodic review, and suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following inf