ISO 16038:2017 Preview

Male condoms -- Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms

ISO 16038:2017 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.


General information

  • Status :  Published
    Publication date : 2017-11
  • Edition : 2
    Number of pages : 12
  • :
    ISO/TC 157
    Non-systemic contraceptives and STI barrier prophylactics
  • 11.200
    Birth control. Mechanical contraceptives

Buy this standard

Format Language
PDF + ePub
Paper
  • CHF58

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information

Subscribe