BS 8404:2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for pharmaceutical products
Hardcopy , PDF
01-31-2009
English
12-21-2001
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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Superseded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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