CAN CSA-Z264 2-1999 Labelling of Drug Ampoules Vials and Prefilled Syringes (First Edition General Instruction No 1 January 1999 General Instruction No 2 October 1999).pdf

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1、Z264.2-99(reaffirmed 2014)Labelling of Drug Ampoules, Vials, and Prefilled SyringesLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the Standards Council of Canada. This process brings

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13、.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA Group shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity o

14、f any such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA Group for informational and non-commercial use only. The user of this document is authorized to do only the following:If this document is in electronic form:sLOADTHISDO

15、CUMENTONTOACOMPUTERFORTHESOLEPURPOSEOFREVIEWINGITsSEARCHANDBROWSETHISDOCUMENTANDsPRINTTHISDOCUMENTIFITISIN0$ and Cover, title page, and copyright page dated October 1999. Update your copy by inserting these revised pages. 0 Keep the pages you remove for reference. CAN/CSA-Z264.2-99 Labelling of Drug

16、 Ampoules, Vials, and Preplled Syringes A National Standard of Canada (approved October 1999) The Canadian Standards Association, which opemtes under the name CSA International (a), under whose auspices this National Standard has been produced, was chartered in 191 9 and accredited by the Standards

17、Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged in standards development and certification activities. CSA standards reRect a national consensus of producers and users - including manufacturers, consumers, ret

18、ailers, unions and professional organizations, and governmental agencies. The standards are used widely by industry and commerce and often adopted by municipal, provincial, and federal governments in their regulations, partiCula* in the fields of health, safety, building and consttuction, and the en

19、vironment. Individuals, companies, and associations across Canada indicate their support for CSAs standards development by volunteering their time and skills to CSA Committee work and supporting the Associations objectives through sustaining memberships. The more than 7000 committee volunteers and t

20、he 2000 sustaining memberships together form CSAs total membership from which its Directors are chosen. Sustaining memberships represent a major source of income for CSAs standards development activities. the Association regularly and continually audits and inspects products that bear the CSA Mark c

21、ountries. Since 191 9, the Association has developed the necessary expertise to meet its corporate mission: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards,

22、certification and related services to meet national and international needs. LArrociation CaMdienne de nomiagsation, maintenant connue SOUS le nom Intemational (CSA), sous les auspices de laquelle cette Norme nationale a t prpare, a regu ses lettres patentes en 191 9 et son accrditation au sein du S

23、ystme de normes nationales par le Conseil canadien des normes en 1973. Association daffiliation libre, sans but lucratif ni pouvoir de rglementation, elle se consacre llaboration de normes et la ceitification. Les normes CSA refltent le consensus de producteurs et dusagers de partout au pays, au nom

24、bre desquels se trouvent des fabricants, des consommateurs, des dtaillants et des reprsentants de syndicab, de corps professionnels et dagences gouvernementales. Lutilisation des normes CSA est trs rpandue dans lindustrie et le commerce, et leur adoption divers ordres de lgislation, tant municipal e

25、t provincial que fdral, est chose courante, particulirement dans les domaines de la sant, de la scurit, du btiment, de la construction et de lenvironnement. Les Canadiens dun bout lautre du pays tmoignent de leur appui au travail de normaliition men par la CSA en participant bnvolement aux travaux d

26、es comits de la CSA et en appuyant ses objectifs par leurs cotisations de membres de soutien. Les quelque 7000 volontaires faisant partie des comits et les 2000 membres de soutien constituent lensemble des membres de la CSA parmi lesquels ses administrateurs sont choisis. Les cotisations des membres

27、 de soutien reprsentent une source importante de revenu pour les services de soutien la normalisation volontaire. LAssociation offre des services de certification et de mise lessai qui appuient et compltent ses activits dans le domaine de llaboration de normes. De manire ascurer lintgrit de son proc

28、essus de certification, lAssociation procde de faon rgulire et continue lexamen et linspection des produits portant la maque CSA Outre son sige social et ses laboratoires Toronto, la CSA possde des bureaux rgionaux dans des centres vitaux partout au Canada, de mme que des agences dinspection et dess

29、ai dans huit pays. Depuis 191 9, lAssociation a parfait les connaksances techniques qui lui permettent de remplir sa mission dentreprise, savoir la CSA est un organisme de services indpendant dont la mission est doffrir une tribune libre et efficace pour la ralisation dactivits facilitant lchange de

30、 biens et de services par lintermdiaire de seMces de normalisation de certification et autres, pour rpondre aux besoins de nos clients, tant lchelle nationale quinternationale. The Association offers certification and testing services in support of and as an extension to its standards development ac

31、tivities. To ensure the integrity of its certification process, In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspection and testing agencies in eight CSA INTERNATIONAL .- Y For futher information on CSA services,

32、 write to Pour plus amples renseignements sur les services de la CSA, sadresser CSA International 178 Rexdale Boulevard 178. boulevard Rexdale Toronto, Ontario, M9W 1 R3 Canada The Standards Council of CaMda is the coordinating body of the National Standards system, a federation of independent, auto

33、nomous organizations working towards the further development and improvement of voluntary standardization in the national interest. of the public, assisting and protecting the consumer, facilitating domestic and international trade, and furthering intemational cooperation in the field of standards.

34、number of capable individuals whose collective interests provide to the greatest practicable extent a balance of representation of producers, users, consumers, and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a sig

35、nificant and timely contribution to the national interest Approval of a standard as a National Standard of Canada indicates that a standard conforms to the criteria and procedures established by the Standards Council of Canada. Approval does not refer to the technical content of the standard; this r

36、emains the continuing responsibility of the accredited standardsdevelopment organmtion. Those who have a need to apply standards are encouraged to use National Standards of Canada whenever practicable. These standards are subject to periodic reviy; therefore, usen are cautioned to obtain the latest

37、edition from the organization preparing the standard. Le Conseil CaMdjen des nonnes est lorganisme de coordination du Systme de normes nationales, une fdration dorganismes indpendants et autonomes qui travaillent au dveloppement et lamlioration de la normaliition volontaire dans lintrt national. le

38、bien+* du public, daider et de protger le consommateur, de faciliter le commerce national et international et de favoriser la coopration internationale dans le domaine de la normalisation. de personnes comptentes dont les intrts runis forment, au degr le plus lev possible, une reprsentation quilibre

39、 des producteurs, utiliiteurs, consommateurs et autres personnes intresses, selon le domaine envisag. II sagit gnralement dune nome qui peut apporter une contribution apprciable, en temps opportun, lintrt national. Lapprobation ne porte pas sur laspect technique de la norme ; cet aspect demeure la r

40、esponsabilit de lorganisme rdacteur de normes accrdit. priodiques ; cest pourquoi il est recommand aux utiliiateun de se procurer ldition la plus rcente de la norme auprs de lorganisme qui la prpare. The principal objects of the Council are to foster and promote voluntary standardization as a means

41、of advancing the national economy, benefiting the health, safety, and welfare A National Standard of Canada is a standard which has been approved by the Standards Council of Canada and one which reflects a reasonable agreement among the views of a Les principaux buts du Conseil sont dencourager et d

42、e promouvoir la normalisation volontaire comme moyen damliorer lconomie nationale, damliorer la sant, la scurit et Une Nome nationale du Canada est une norme, approuve par le Conseil canadien des normes, qui reflte une entente raisonnable parmi les points de vue dun certain nombre Lapprobation dune

43、norme en tant que Norme nationale du Canada indique quelle est conforme aux mthodes et critres tablis par le Conseil canadien des normes. II est recommand aux personnes qui ont besoin de normes de se servir des Normes nationales du Canada loque la chose est possible. Ces norme font lobjet dexamens T

44、he responsibiliifor approving National Standards of Canada rests with the La responsabilit dapprouver les Normes nationales du Canada incombe au Standards Council of Canada Conseil canadien des normes 45 OConnor Street, Suite 1200 45, rue OConnor, Bureau 1200 Ottawa, Ontario, K1 P 6N7 Canada Nationa

45、l Standards of Canada are published in Engliih and French. Les normes nationales du Canada sont publies en versions franaise et anglaise. Although the intended primary application of this Standard is stated in its Scope, it is imprtant to note that it remains the mpnsibility of the user to judge its

46、 suitability for their particulor purpose. Bien que le but premier vis par cette nome soit nonc sous sa mbrique Domaine dapplication, il est important de retenir quil incombe O lutilisateur de juger si la norme convent ses besoins particulier. National Standard of Canada CAN/CSA-Z264.2-99 (approved

47、October 1999) Labelling of Dru. Ampoules, Vials, and Prefllled Syringes Prepared by Canadian Standards Association CSA I N T E R N AT I O N AL Approved by Standards Council of Canada ISSN 03 17-5669 Published in january 1999 by Canadian Standards Association 7 78 Rexdale Boulevard, Etobicoke, Ontari

48、o, Canada M9W 7 R3 Technical Editor: Grant Gillis Managing Editor: Gary Burford Senior Project Editor: Ann Martin Editors: Maria Adragna/Sandra Hawryn Publishing System Coordinators: O Canadian Standards Association - 1999 All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. Kelly Coram/Ursula Das/Grace Da Silva/Seetha Rajagopalan (Copyright page replaced October 7 999) General Instruction No. 1Z264.2-99January 1