ISO 16038:2005
Rubber condoms — Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
ISO 16038:2005 provides guidance on using ISO 4074 and addresses quality issues to be considered during the development, manufacture, quality verification and procurement of condoms. It encompasses the aspects of quality management systems in design, manufacture and delivery of condoms with emphasis on performance, safety and reliability of condoms.
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TitlePage - Rubber condoms— Guidance on the use of ISO 4074 in the quality management of natural...
TableofContent - Contents Page
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 4 Quality of design
Subclause2 - 4.1 General
Subclause2 - 4.2 Clinical investigation
Subclause2 - 4.3 Risk management
Subclause3 - 4.3.1 Risk analysis and risk management
Subclause3 - 4.3.2 Latex allergy
Subclause3 - 4.3.3 Bioburden
Clause1 - 5 Quality of manufacture
Subclause2 - 5.1 Quality management
Subclause2 - 5.2 Lot testing (finished-product testing)
Subclause2 - 5.3 Rounding-off values
Clause1 - 6 Quality in procurement
Clause1 - 7 Quality in testing
Clause1 - 8 Important parameters to be considered when using ISO4074
Subclause2 - 8.1 Size
Subclause2 - 8.2 Resistance to breakage
Subclause2 - 8.3 Compatibility of materials
Subclause2 - 8.4 Shelf-life and resistance to degradation
Subclause2 - 8.5 Packaging and labelling
Subclause2 - 8.6 Type testing
Subclause2 - 8.7 Lubricants
Clause1 - 9 Sampling
Bibliography - Bibliography
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TitlePage - Rubber condoms— Guidance on the use of ISO 4074 in the quality management of natural...
TableofContent - Contents Page
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 4 Quality of design
Subclause2 - 4.1 General
Subclause2 - 4.2 Clinical investigation
Subclause2 - 4.3 Risk management
Subclause3 - 4.3.1 Risk analysis and risk management
Subclause3 - 4.3.2 Latex allergy
Subclause3 - 4.3.3 Bioburden
Clause1 - 5 Quality of manufacture
Subclause2 - 5.1 Quality management
Subclause2 - 5.2 Lot testing (finished-product testing)
Subclause2 - 5.3 Rounding-off values
Clause1 - 6 Quality in procurement
Clause1 - 7 Quality in testing
Clause1 - 8 Important parameters to be considered when using ISO4074
Subclause2 - 8.1 Size
Subclause2 - 8.2 Resistance to breakage
Subclause2 - 8.3 Compatibility of materials
Subclause2 - 8.4 Shelf-life and resistance to degradation
Subclause2 - 8.5 Packaging and labelling
Subclause2 - 8.6 Type testing
Subclause2 - 8.7 Lubricants
Clause1 - 9 Sampling
Bibliography - Bibliography