Foreword
Introduction
1 Scope
2 Terms and definitions
3 Method
3.1 Principle
3.2 Test conditions
3.3 Apparatus
3.4 Conditioning of BSF
3.5 Sample size
3.6 Procedure
4 Calculation and expression of test results
5 Test report
Annex A (normative) Conditioning of BSF
Annex B (informative) Aerosol particle size distribution
Annex C (informative) Rationale for chosen test method
Annex D (informative) Clauses of this part of ISO 23328
addressing the essential principles of ISO/TR 16142
Requirements of EU Directive 93/42/EEC Medical devices
Annex ZA (informative) Relationship between this European
Standard and the Essential
Bibliography
National Annex NA (informative) Bibliography