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  • BS 8404:2001

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for pharmaceutical products

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-01-2009

    Language(s):  English

    Published date:  21-12-2001

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Committees responsible
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
      4.1 General requirements
      4.2 Performance requirements
    5 Testing
      5.1 Principle
      5.2 Samples and sample preparation
      5.3 Procedure
      5.4 Evaluation
      5.5 Overall test result
    6 Test report
      6.1 General
      6.2 Child test
      6.3 Adult test
      6.4 Additional (optional) information to be
          recorded
      6.5 Overall test result
    Annex A (informative) Guidance for persons supervising
            tests with children
            A.1 Parental/guardian consent
            A.2 Surroundings and personnel
            A.3 Social circumstances of the children
            A.4 History of previous poisoning
            A.5 Avoidance of distractions
            A.6 Position of the children
            A.7 Behaviour of the supervisor during the test
    Annex B (normative) Test charts
    Annex C (informative) Suitability of the test procedures
            chosen
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides performance requirements and methods of test for non-reclosable packaging for pharmaceutical products that have been designated child-resistant.

    General Product Information - (Show below) - (Hide below)

    Committee PKW/0
    Development Note Reviewed and confirmed by BSI, February 2008. (01/2008) Inactive for the new design. (11/2008)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 45014 : 1998 GENERAL CRITERIA FOR SUPPLIER'S DECLARATION OF CONFORMITY
    EN 45010 : 1998 GENERAL REQUIREMENTS FOR ASSESSMENT AND ACCREDITATION OF CERTIFICATION/REGISTRATION BODIES
    BS EN ISO 9001:2015 Quality management systems. Requirements
    EN 45003 : 1995 CALIBRATION AND TESTING LABORATORY ACCREDITATION SYSTEM - GENERAL REQUIREMENTS FOR OPERATION AND RECOGNITION
    EN 45011:1998 General requirements for bodies operating product certification systems (ISO/IEC Guide 65:1996)
    EN 45002:1989 GENERAL CRITERIA FOR THE ASSESSMENT OF TESTING LABORATORIES
    EN 45011 : 1998 GENERAL REQUIREMENTS FOR BODIES OPERATING PRODUCT CERTIFICATION SYSTEMS
    BS EN 862:2005 Packaging. Child resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
    EN 45002:1989 GENERAL CRITERIA FOR THE ASSESSMENT OF TESTING LABORATORIES
    EN 45013 : 1989 GENERAL CRITERIA FOR CERTIFICATION BODIES OPERATING CERTIFICATION OF PERSONNEL
    EN 45012 : 1998 GENERAL REQUIREMENTS FOR BODIES OPERATING ASSESSMENT AND CERTIFICATION/REGISTRATION OF QUALITY SYSTEMS
    EN 45004 : 1995 GENERAL CRITERIA FOR THE OPERATION OF VARIOUS TYPES OF BODIES PERFORMING INSPECTION
    EN 45013:1989 GENERAL CRITERIA FOR CERTIFICATION BODIES OPERATING CERTIFICATION OF PERSONNEL
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