BS ISO 16038:2017 – TC:2020 Edition
$186.33
Tracked Changes. Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 51 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 29 | National foreword |
| 33 | Foreword |
| 35 | Introduction |
| 38 | 1 Scope 2 Normative references 3 Terms and definitions 4 Quality of design 4.1 General |
| 40 | 4.2 Clinical investigation 4.3 Risk management 4.3.1 Risk analysis and risk management 4.3.2 Latex allergy |
| 41 | 4.3.3 Microbial contamination (bioburden) 4.3.4 Nitrosamines 5 Quality of manufacture 5.1 Quality management 5.2 Lot testing (finished product testing) |
| 42 | 5.3 Rounding-off values 6 Quality in procurement |
| 43 | 7 Quality in testing 8 Important parameters to consider when using ISO 4074 and ISO 23409 8.1 Application of ISO 4074 and ISO 23409 8.2 Dimensions |
| 44 | 8.3 Visibly open seals 8.4 Justification of additional claims 8.5 Compatibility of materials 8.6 Freedom from holes |
| 45 | 8.7 Shelf life and resistance to degradation |
| 46 | 8.8 Packaging and labelling 8.9 Type testing |
| 47 | 8.10 Lubricants 9 Sampling |
| 48 | Bibliography |
