BS ISO 16038:2005:2006 Edition
$102.76
Rubber condoms. Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
| Published By | Publication Date | Number of Pages |
| BSI | 2006 | 20 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 3 | TitlePage – Rubber condoms�— Guidance on the use of ISO 4074 in the quality management of natural… |
| 5 | TableofContent – Contents Page |
| 6 | Foreword – Foreword |
| 7 | Introduction – Introduction |
| 9 | Scope – 1��� Scope NormativeReference – 2��� Normative references Clause1 – 4��� Quality of design Subclause2 – 4.1��� General |
| 10 | Subclause2 – 4.2��� Clinical investigation Subclause2 – 4.3��� Risk management Subclause3 – 4.3.1��� Risk analysis and risk management Subclause3 – 4.3.2��� Latex allergy |
| 11 | Subclause3 – 4.3.3��� Bioburden Clause1 – 5��� Quality of manufacture Subclause2 – 5.1��� Quality management Subclause2 – 5.2��� Lot testing (finished-product testing) Subclause2 – 5.3��� Rounding-off values Clause1 – 6��� Quality in procurement |
| 12 | Clause1 – 7��� Quality in testing Clause1 – 8��� Important parameters to be considered when using ISO�4074 Subclause2 – 8.1��� Size |
| 13 | Subclause2 – 8.2��� Resistance to breakage Subclause2 – 8.3��� Compatibility of materials Subclause2 – 8.4��� Shelf-life and resistance to degradation |
| 17 | Subclause2 – 8.5��� Packaging and labelling Subclause2 – 8.6��� Type testing |
| 18 | Subclause2 – 8.7��� Lubricants Clause1 – 9��� Sampling |
| 19 | Bibliography – Bibliography |
