ISO 25841:2017
Current
Current
The latest, up-to-date edition.
Female condoms — Requirements and test methods
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English
Published date
08-14-2017
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ISO 25841:2017 specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).
| Committee |
ISO/TC 157
|
| DevelopmentNote |
Supersedes ISO/DIS 25841. (08/2017) NEW CHILD AMD 1 IS ADDED
|
| DocumentType |
Standard
|
| Pages |
54
|
| ProductNote |
NEW CHILD AMD 1 IS ADDED
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IS 17962 : 2022 | Identical |
| NEN ISO 25841 : 2017 | Identical |
| BS ISO 25841:2017 | Identical |
| 14/30296035 DC : 0 | BS ISO 29943-2 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS |
| ISO 29943-2:2017 | Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports |
| BS ISO 29943-2:2017 | Condoms. Guidance on clinical studies Female condoms, clinical function studies based on self-reports |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 11346:2014 | Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| 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 |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| 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/IEC 17007:2009 | Conformity assessment — Guidance for drafting normative documents suitable for use for conformity assessment |
| ISO/TR 8550-1:2007 | Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 1: Acceptance sampling |
| ISO/TR 8550-2:2007 | Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 2: Sampling by attributes |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 29943-2:2017 | Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports |
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