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ISO 16038:2017-ed.2.0
Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
Translate name
STANDARD published on 6.12.2017
The information about the standard:
Designation standards: ISO 16038:2017-ed.2.0
Publication date standards: 6.12.2017
SKU: NS-803316
The number of pages: 12
Approximate weight : 36 g (0.08 lbs)
Country: International technical standard
Category: Technical standards ISO
The category - similar standards:
Annotation of standard text ISO 16038:2017-ed.2.0 :
Description / Abstract: 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.
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