BS EN ISO 4074:2015
Current
The latest, up-to-date edition.
Natural rubber latex male condoms. Requirements and test methods
Hardcopy , PDF
English
11-30-2015
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Lot size
6 Biocompatibility
7 Microbial contamination
8 Product claims
9 Design
10 Bursting volume and pressure
11 Stability and shelf life
12 Freedom from holes
13 Visible defects
14 Package integrity of individual container
15 Packaging and labelling
16 Test report
Annex A (normative) - Sampling plans intended for assessing
compliance of a continuing series of lots of sufficient
number to allow the switching rules to be applied
Annex B (informative) - Sampling plans intended for
assessing 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 microbial
contamination
Annex H (normative) - Determination of bursting
volume and pressure
Annex I (normative) - Oven treatment for condoms
Annex J (informative) - Determination of force and
elongation at break of test pieces of condoms
Annex K (normative) - Determination of shelf life by
real-time stability studies
Annex L (informative) - Guidance on conducting and
analysing accelerated ageing studies
Annex M (normative) - Testing for holes
Annex N (normative) - Testing for package integrity
Annex O (informative) - Calibration of air inflation
equipment for determination of bursting volume
and pressure
Annex P (informative) - Recommendations for testing
condoms that fall outside of the size
ranges specified in ISO 4074
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices
Defines requirements and test methods for male condoms made from natural rubber latex.
| Committee |
CH/157
|
| DevelopmentNote |
Supersedes 99/565033 DC. (05/2002) Supersedes BS EN 600 and BS 3704(1996). (02/2005) 2002 Edition along with its amendment and corrigendum remains current and will be withdrawn on 11/11/2017. Supersedes 12/30251858 DC. (11/2015)
|
| DocumentType |
Standard
|
| Pages |
72
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard specifies requirements and test methods for male condoms made from natural rubber latex.
| Standards | Relationship |
| EN ISO 4074:2015 | Identical |
| I.S. EN ISO 4074:2015 | Identical |
| NS EN ISO 4074 : 2002 | Identical |
| UNE-EN ISO 4074:2016 | Identical |
| ISO 4074:2015 | Identical |
| DIN EN ISO 4074:2016-05 | Identical |
| SN EN ISO 4074 : 2016 | Identical |
| UNI EN ISO 4074 : 2002 | Identical |
| NBN EN ISO 4074 : 2015 | Identical |
| NF EN ISO 4074 : 2015 | Identical |
| NEN EN ISO 4074 : 2015 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| 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 |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| ISO 16038:2005 | Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 3534-2:2006 | Statistics — Vocabulary and symbols — Part 2: Applied statistics |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ASTM D 3492 : 2016 : REDLINE | Standard Specification for Rubber Contraceptives (Male Condoms) |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 5893:2002 | Rubber and plastics test equipment Tensile, flexural and compression types (constant rate of traverse) Specification |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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