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BS 8404:2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for pharmaceutical products
Available format(s)

Hardcopy , PDF

Superseded date

01-31-2009

Language(s)

English

Published date

12-21-2001

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

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

Committee
PKW/0
DevelopmentNote
Reviewed and confirmed by BSI, February 2008. (01/2008) Inactive for the new design. (11/2008)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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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