Rubber condoms for clinical trials Measurement of physical properties

Amended by

ISO 16037:2002/Amd 1:2011

Available format(s)

PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Published date

30-05-2002

Publisher

International Organization for Standardization

This International Standard is intended as a guideline for clinical researchers working with condoms. It suggests a

series of laboratory tests to be conducted on the products to be used in any clinical investigation, so that it will be

easier to relate the clinical results to the design and quality of the condoms used.

This International Standard is not applicable to the design of clinical investigations.

DevelopmentNote	Supersedes ISO/FDIS 16037 (06/2002)
DocumentType	Standard
Pages	5
PublisherName	International Organization for Standardization
Status	Current

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ISO 16038:2017	Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
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BS ISO 16038:2017	Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
BS ISO 23409:2011	Male condoms. Requirements and test methods for condoms made from synthetic materials
ISO 29943-2:2017	Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports
ISO 23409:2011	Male condoms Requirements and test methods for condoms made from synthetic materials
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ISO 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 4074:2015	Natural rubber latex male condoms Requirements and test methods
ISO 37:2017	Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 14971:2007	Medical devices Application of risk management to medical devices

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ISO 16037:2002