16/30346829 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS
Hardcopy , PDF
01-31-2018
English
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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 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Superseded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 |
| 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 |
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