BS ISO 16038:2017
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
Hardcopy , PDF
English
03-01-2018
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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.
| Committee |
CH/157
|
| DevelopmentNote |
Supersedes 16/30346829 DC. (01/2018)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| 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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