16/30346829 DC : 0

Superseded

View Superseded by

BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS

Available format(s)

Hardcopy , PDF

Superseded date

01-31-2018

Language(s)

English

Publisher

British Standards Institution

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 be considered
when using ISO 4074 and ISO 23409
9 Sampling
Bibliography

BS ISO 16038.

Committee	CH/157
DocumentType	Draft
Pages	20
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS ISO 16038:2005

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
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/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 23409:2011	Male condoms Requirements and test methods for condoms made from synthetic materials
ISO/TR 13425:2006	Guidelines for the selection of statistical methods in standardization and specification
ISO 29941:2010	Condoms — Determination of nitrosamines migrating from natural rubber latex 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 14971:2007	Medical devices Application of risk management to medical devices
EN 980:2008	Symbols for use in the labelling of medical devices
ISO 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied