BS ISO 16038:2017:2018 Edition
$142.49
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 | 2018 | 24 |
This document provides guidance on using ISO 4074 and ISO 23409 and addresses quality issues to be considered during the development, manufacture, quality verification and procurement of condoms. It encompasses the aspects of quality management systems in the design, manufacture and delivery of condoms with an emphasis on performance, safety and reliability.
Male condoms are either made from essentially natural rubber latex, in which case the requirements of ISO 4074 are applicable, or from synthetic materials and/or blends of synthetic materials and natural rubber latex, in which case the requirements of ISO 23409 are applicable. This document outlines the aspects applicable to both types of condoms with specific clarifications where appropriate.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 6 | Foreword |
| 8 | Introduction |
| 11 | 1 Scope 2 Normative references 3 Terms and definitions 4 Quality of design 4.1 General |
| 13 | 4.2 Clinical investigation 4.3 Risk management 4.3.1 Risk analysis and risk management 4.3.2 Latex allergy |
| 14 | 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) |
| 15 | 5.3 Rounding-off values 6 Quality in procurement |
| 16 | 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 |
| 17 | 8.3 Visibly open seals 8.4 Justification of additional claims 8.5 Compatibility of materials 8.6 Freedom from holes |
| 18 | 8.7 Shelf life and resistance to degradation |
| 19 | 8.8 Packaging and labelling 8.9 Type testing |
| 20 | 8.10 Lubricants 9 Sampling |
| 21 | Bibliography |
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