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12/30251858 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Hardcopy , PDF

Superseded date

11-30-2015

Language(s)

English

Foreword
Introduction
1 Scope
2 Normative references
2 Terms and definitions
3 Quality verification
4 Lot size
5 Biocompatibility
6 Microbial contamination
7 Product claims
8 Design
9 Bursting volume and pressure
10 Stability and shelf life
11 Freedom from holes
12 Visible defects
13 Package integrity of individual container
14 Packaging and labelling
15 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) - Method for the 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
         International Standard and the Essential
         Requirements of EU Directives 93/42/EEC

BS ISO 4074

Committee
CH/157
DocumentType
Draft
Pages
69
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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 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 2230:2002 Rubber products — Guidelines for storage
ISO 16038:2005 Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
ISO 16037:2002 Rubber condoms for clinical trials Measurement of physical properties
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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9001:2015 Quality management systems — Requirements
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 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 14971:2007 Medical devices Application of risk management to medical devices
EN 980:2008 Symbols for use in the labelling of medical devices

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