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BSI - BS ISO 16038 - TC

Tracked Changes (Redline) – Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms

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Organization: BSI
Publication Date: 26 February 2020
Status: active
Page Count: 51
ICS Code (Birth control. Mechanical contraceptives): 11.200
scope:

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.

Document History

BS ISO 16038 - TC
February 26, 2020
Tracked Changes (Redline) – Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
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...

References

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