PD ISO/TR 15499:2016
Current
The latest, up-to-date edition.
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Hardcopy , PDF
English
31-01-2017
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Biological evaluation as a risk management
practice
5 Guidance on risk management
6 Guidance on specific aspects of biological
evaluation
Bibliography
Pertains to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.
| Committee |
CH/194
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This document is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO10993-1. It does not add to, or otherwise change, the requirements of ISO10993-1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
| Standards | Relationship |
| ISO/TR 15499:2016 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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