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    • CAN/CSA-Z264.2-99 (R2014)
    Codes & Standards - Subscribe

    CAN/CSA-Z264.2-99 (R2014)

    Labelling of Drug Ampoules, Vials and Prefilled Syringes

    SKU: 2700773 Published by CSA Group Publication Year 1999 Reaffirmed in 2014 Withdrawn

    Product Details

    • Preface/Scope
    • Items Included

    Preface


    This is the first edition of CSA Standard 2264.2, Labelling of Drug Ampoules, Vials, and Prefilled Syringes. This Standard has been developed based on the Guidelines for Drug Packaging and Labelling for Manufacturers developed by the Canadian Society of Hospital Pharmacists (CSHP). This Standard is written in SI (metric) units.


    Patient safety with respect to drug administration is a major concern for everyone involved in the delivery of health care. Accurate selection of the correct drug product is necessary for safe drug administration. Label design can enhance the legibility of a label and increase product recognition, hereby supporting the goal of safe drug administration.


    This Standard was developed by the Subcommittee on Labelling and Packaging of Drug Ampoules and Vials under the jurisdiction of the Technical Committee on Drug-Related Standards and the Strategic Steering Committee on Health Care Technology, and was formally approved by the Technical Committee. it will be submitted to the Standards Council of Canada for approval as a National Standard of Canada.


    Scope


    1.1

    This Standard defines minimum design requirements for the presentation of critical information on inner labels for p arenteral drug products provided in ampoules, vials, or prefilled syringes, including those requiring reconstitution. These requirements are intended to facilitate the identification and safe administration of parenteral drug products for human use. This Standard complements the requirements contained in the Food and Drugs Act and Regulations; labels conforming to this Standard are also expected to conform to the Act and applicable Regulations.


    1.2

    This Standard does not provide requirements for packaging, outer labels, or medical inhalants, and does not provide specifications for the physical components of the container.


    1.3

    In this Standard, shall indicates a mandatory requirement; should indicates a recommendation or that which is advised but not mandatory; and may indicates an advisory or optional statement. Figures, tables, and accompanying legends are mandatory; the appendices and notes are not mandatory. The purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered to be part of the figure or table and are written as mandatory requirements.

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    CAN/CSA-Z264.2-99 (R2014)

    Labelling of Drug Ampoules, Vials and Prefilled Syringes

    Withdrawn
    English

    CAN/CSA-Z264.2-F99 (C2014)

    Étiquetage des ampoules, des fioles et des seringues à cartouches utilisées pour les médicaments

    Withdrawn
    French
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    GST REG No R119441681
    QST REG No R1006017360

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    Select the subscription format that is right for you. Table with 13 rows and 3 columns, identifies features available and not available for the two different subscription formats - CSA Advantage TM and CSA OnDemand TM
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    Offline access CSA AdvantageTM. feature available. Offline access CSA OnDemandTM. feature available. Offline access
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    Newest editions added automatically CSA AdvantageTM. feature available. Newest editions added automatically CSA OnDemandTM. feature available. Newest editions added automatically
    Includes all supported languages and archive versions CSA AdvantageTM. feature not available. Includes all supported languages and archive versions CSA OnDemandTM. feature available. Includes all supported languages and archive versions
    My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference CSA AdvantageTM. feature available. My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference CSA OnDemandTM. feature not available. My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference
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    Export personal notes to Excel CSA AdvantageTM. feature available. Export personal notes to Excel CSA OnDemandTM. feature not available. Export personal notes to Excel
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