ISO 16037:2002

Current

Current The latest, up-to-date edition.

Rubber condoms for clinical trials Measurement of physical properties

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Published date: 30-05-2002

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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.

Development Note	Supersedes ISO/FDIS 16037 (06/2002)
Document Type	Standard
ISBN
Pages
Published
Publisher	International Organization for Standardization
Status	Current

08/30133979 DC : DRAFT MAY 2008	BS ISO 23409 - MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
ISO 29943-1:2017	Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
16/30346829 DC : 0	BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
BS ISO 29943-1:2017	Condoms. Guidance on clinical studies Male condoms, clinical function studies based on self-reports
ISO 16038:2017	Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
14/30296392 DC : 0	BS ISO 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
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
12/30251858 DC : 0	BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
BS ISO 29943-2:2017	Condoms. Guidance on clinical studies Female condoms, clinical function studies based on self-reports

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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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.

Development Note	Supersedes ISO/FDIS 16037 (06/2002)
Document Type	Standard
ISBN
Pages
Published
Publisher	International Organization for Standardization
Status	Current

08/30133979 DC : DRAFT MAY 2008	BS ISO 23409 - MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS
ISO 29943-1:2017	Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
16/30346829 DC : 0	BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
BS ISO 29943-1:2017	Condoms. Guidance on clinical studies Male condoms, clinical function studies based on self-reports
ISO 16038:2017	Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
14/30296392 DC : 0	BS ISO 29943-1 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS
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
12/30251858 DC : 0	BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
BS ISO 29943-2:2017	Condoms. Guidance on clinical studies Female condoms, clinical function studies based on self-reports

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