BS ISO 23409:2011
Current
The latest, up-to-date edition.
Male condoms. Requirements and test methods for condoms made from synthetic materials
Hardcopy , PDF
English
31-03-2011
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Lot size
6 Biocompatibility
7 Product claims
8 Design
9 Preclinical evaluation
10 Clinical (human use) investigations
11 Bursting volume and pressure
12 Freedom from holes
13 Stability and shelf-life
14 Visible defects
15 Package integrity for individual container
16 Packaging and labelling
17 Data sheet and test report
Annex A (normative) - Sampling plans intended for assessing
compliance of a continuing series of lots with
sufficient number to allow the switching rules
to be applied
Annex B (informative) - Sampling plans that are intended
for assessing the compliance of isolated lots
Annex C (normative) - Determination of total lubricant for
condoms in individual containers
Annex D (normative) - Determination of length
Annex E (normative) - Determination of width
Annex F (normative) - Determination of thickness
Annex G (informative) - Determination of barrier properties
using the bacteriophage method
Annex H (normative) - Determination of the bursting volume
and pressure
Annex I (informative) - Calibration of air inflation
equipment for determination of burst volume
volume and pressure
Annex J (normative) - Testing for holes
Annex K (normative) - Determination of shelf-life by
real-time stability tests
Annex L (informative) - Guidance on conducting and
analysing ageing studies
Annex M (normative) - Tests for individual container
integrity
Annex N (informative) - Oven treatment for condoms made
from synthetic materials
Bibliography
Describes 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.
| Committee |
CH/157
|
| DevelopmentNote |
Supersedes 08/30133979 DC. (03/2011)
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard 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.
| Standards | Relationship |
| ISO 23409:2011 | Identical |
| 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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