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ISO 23409:2011

Current
Current

The latest, up-to-date edition.

Male condoms Requirements and test methods for condoms made from synthetic materials
Available format(s)

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

Language(s)

English

Published date

03-02-2011

Publisher

International Organization for Standardization

ISO 23409:2011 specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.

DevelopmentNote
Supersedes ISO/DIS 23409. (02/2011)
DocumentType
Standard
Pages
44
PublisherName
International Organization for Standardization
Status
Current

Standards Relationship
SANS 23409 : 1ED 2011 Identical
BIS IS/ISO 23409 : 2015 Identical
BS ISO 23409:2011 Identical
GOST ISO 23409 : 2014 Identical
NEN ISO 23409 : 2011 Identical
SANS 23409:2011(R2017) Identical

15/30302532 DC : 0 BS ISO 19671 - ADDITIONAL LUBRICANTS FOR CONDOMS - EFFECT ON CONDOM STRENGTH
ISO 29943-1:2017 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
BS ISO 29943-1:2017 Condoms. Guidance on clinical studies Male condoms, clinical function studies based on self-reports
ASTM D 6324 : 2011 Standard Test Methods for Male Condoms Made from Polyurethane
ISO 16038:2017 Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
16/30346829 DC : 0 BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT 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
ASTM D 6324 : 2011 : R2017 Standard Specification for Male Condoms Made from Polyurethane

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 11346:2014 Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use
2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 188:2011 Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2230:2002 Rubber products — Guidelines for storage
ISO 16038:2005 Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
ISO 16037:2002 Rubber condoms for clinical trials Measurement of physical properties
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 29943-1:2017 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 980:2008 Symbols for use in the labelling of medical devices
ISO/IEC Guide 7:1994 Guidelines for drafting of standards suitable for use for conformity assessment

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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