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I.S. EN ISO 4074:2015

Current
Current

The latest, up-to-date edition.

NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
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.

DevelopmentNote
Supersedes I.S. EN 600 (01/2003)
DocumentType
Standard
Pages
78
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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
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)
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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