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BS ISO 16038:2017

Current
Current

The latest, up-to-date edition.

Male condoms. Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-01-2018

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality of design
5 Quality of manufacture
6 Quality in procurement
7 Quality in testing
8 Important parameters to consider when using
  ISO 4074 and ISO 23409
9 Sampling
Bibliography

Gives guidance on using ISO 4074 and ISO 23409 and addresses quality issues to be considered during the development, manufacture, quality verification and procurement of condoms.

This document provides guidance on using ISO4074 and ISO23409 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 the design, manufacture and delivery of condoms with an emphasis on performance, safety and reliability.

Male condoms are either made from essentially natural rubber latex, in which case the requirements of ISO4074 are applicable, or from synthetic materials and/or blends of synthetic materials and natural rubber latex, in which case the requirements of ISO23409 are applicable. This document outlines the aspects applicable to both types of condoms with specific clarifications where appropriate.

Committee
CH/157
DevelopmentNote
Supersedes 16/30346829 DC. (01/2018)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 16038:2017 Identical

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 11346:2014 Rubber, vulcanized or thermoplastic — Estimation of life-time and maximum temperature of use
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
ASTM D 5712 : 2015 : REDLINE Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
ISO 16037:2002 Rubber condoms for clinical trials Measurement of physical properties
ISO 23409:2011 Male condoms Requirements and test methods for condoms made from synthetic materials
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 29941:2010 Condoms — Determination of nitrosamines migrating from natural rubber latex condoms
ASTM D 3492 : 2016 : REDLINE Standard Specification for Rubber Contraceptives (Male Condoms)
ISO 2859-10:2006 Sampling procedures for inspection by attributes Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 4074:2015 Natural rubber latex male condoms Requirements and test methods
ISO 80000-1:2009 Quantities and units — Part 1: General
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 29943-1:2017 Condoms — Guidance on clinical studies — Part 1: Male condoms, clinical function studies based on self-reports
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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