Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

15-06-2016

Publisher

Asociacion Espanola de Normalizacion

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	UNE-EN ISO 4074:2002 UNE-EN ISO 4074/AC:2004 UNE-EN ISO 4074:2002/AC:2008 UNE-EN 600:1996

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

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
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

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UNE-EN ISO 4074:2016

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Abstract

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