UNE-EN ISO 4074:2016
Current
The latest, up-to-date edition.
Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
Hardcopy , PDF
Spanish, Castilian, English
06-15-2016
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1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
5 Design
6 Burst volume and pressure
7 Tests for stability and shelf life
8 Freedom from holes
9 Visible defects
10 Package integrity
11 Packaging and labelling
12 Test report
Annexes
A Sampling plans intended for accessing compliance of a
continuing series of lots of sufficient number to allow the
switching rules to be applied
B Sampling plans intended for accessing compliance of isolated
lots
C Determination of total lubricant for condoms in individual
containers
D Determination of length
E Determination of width
F Determination of thickness
G Determination of bursting volume and pressure
H Oven treatment for condoms
I Determination of force and elongation at break of test pieces of
condoms
J Determination of shelf life by real-time stability studies
K Guidance on conducting and analysing accelerated ageing
studies
L Testing for holes
M Test for package integrity
N Calibration of air inflation equipment for determination of
burst volume and pressure
P Rationale
Bibliography
Defines the minimum requirements and the test methods to be used for condoms made from natural rubber latex which are supplied to consumers for contraceptive purposes and to assist in the prevention of sexually transmitted infections.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 600. (09/2005)
|
| DocumentType |
Standard
|
| Pages |
72
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 4074 : 2015 | Identical |
| ISO 4074:2015 | Identical |
| NBN EN ISO 4074 : 2015 | Identical |
| NEN EN ISO 4074 : 2015 | Identical |
| NS EN ISO 4074 : 2002 | Identical |
| I.S. EN ISO 4074:2015 | Identical |
| SN EN ISO 4074 : 2016 | Identical |
| UNI EN ISO 4074 : 2002 | Identical |
| BS EN ISO 4074:2015 | Identical |
| EN ISO 4074:2015 | Identical |
| DIN EN ISO 4074:2016-05 | Identical |
| BS 4026-4:1969 | 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 |
| 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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