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ISO 4074

Natural rubber latex male condoms - Requirements and test methods

active, Most Current
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Organization: ISO
Publication Date: 15 October 2015
Status: active
Page Count: 66
ICS Code (Birth control. Mechanical contraceptives): 11.200
scope:

This International Standard specifies requirements and test methods for male condoms made from natural rubber latex.

Document History

ISO 4074
October 15, 2015
Natural rubber latex male condoms - Requirements and test methods
This International Standard specifies requirements and test methods for male condoms made from natural rubber latex.
ISO 4074
August 15, 2014
Natural rubber latex male condoms - Requirements and test methods
This International Standard specifies requirements and test methods for male condoms made from natural rubber latex.
ISO 4074
April 15, 2008
Natural latex rubber condoms — Requirements and test methods TECHNICAL CORRIGENDUM 2
A description is not available for this item.
ISO 4074
November 1, 2003
Natural latex rubber condoms — Requirements and test methods
A description is not available for this item.
ISO 4074
February 15, 2002
Natural latex rubber condoms - Requirements and test methods
This International Standard specifies the minimum requirements and the test methods to be used for condoms made from natural rubber latex which are supplied to consumers for contraceptive purposes...

References

This document references:
ASTM D3492 - Standard Specification for Rubber Contraceptives (Male Condoms)
Published by ASTM on July 1, 2016
This specification covers the minimum requirements for individually packaged male condoms made from natural rubber latex and intended for single use. This specification does not cover the...
This document references:
ISO 16038 - Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
Published by ISO on November 1, 2017
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...
This document references:
ASTM D3492 - Standard Specification for Rubber Contraceptives (Male Condoms)
Published by ASTM on July 1, 2016
This specification covers the minimum requirements for individually packaged male condoms made from natural rubber latex and intended for single use. This specification does not cover the...
This document references:
EN 1041 - Information supplied by the manufacturer of medical devices
Published by CEN on August 1, 2008
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
This document references:
ISO 11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
Published by ISO on January 1, 2018
This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw...
This document references:
ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
Published by ISO on March 1, 2016
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
ISO 16038 - Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
Published by ISO on November 1, 2017
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...
This document is referenced by:
ISO 25841 - Female condoms — Requirements and test methods AMENDMENT 1
Published by ISO on April 1, 2020
A description is not available for this item.
This document is referenced by:
D7160 - Standard Practice for Determination of Expiration Dating for Medical Gloves
June 1, 2016
This practice covers all surgeon’s and examination gloves made from either synthetic or natural rubber latex. The purpose of this practice is to establish methods for testing medical gloves and...
This document is referenced by:
ISO 29943-1 - Condoms - Guidance on clinical studies - Part 1: Male condoms, clinical function studies based on self-reports
Published by ISO on July 1, 2017
This document is intended to help in the design, execution, analysis and interpretation of clinical function studies conducted in accordance with the requirements of ISO 23409 for male synthetic...
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