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
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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 |
| BIS IS/ISO 23409 : 2015 | Identical |
| BS ISO 23409:2011 | Identical |
| GOST ISO 23409 : 2014 | Identical |
| NEN ISO 23409 : 2011 | Identical |
| SS-ISO 23409:2024 | 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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