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
Annex ZA (informative) - Relationship between this European
Standard and the Essential
Requirements of EU Directive
93/42/EEC Medical devices
Bibliography