17/30344601 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation
of medical devices
5 Categorization of medical devices
6 Biocompatibility evaluation process
7 Interpretation of biological evaluation data and
overall biological safety assessment
Annex A (informative) - Endpoints to be addressed
in a biological risk assessment
Annex B (informative) - Guidance on the conduct of
biological evaluation within a risk management
process
Annex C (informative) - Suggested procedure for
literature review
Annex ZA (informative) - Relationship between this
European Standard and the essential requirements
of Directive 93/42/EEC [OJ L 169] aimed to be covered
Annex ZB (informative) - Relationship between this
European Standard and the essential requirements
of Directive 90/385/EEC [OJ L 189] aimed to be covered
Bibliography
BS EN ISO 10993-1.
| Committee |
CH/194
|
| DocumentType |
Draft
|
| Pages |
53
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO/TR 10993-22:2017 | Biological evaluation of medical devices — Part 22: Guidance on nanomaterials |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
| 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/TR 10993-33:2015 | Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3 |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 7405:2008 | Dentistry — Evaluation of biocompatibility of medical devices used in dentistry |
| 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 10993-10:2010 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization |
| ISO 9004:2009 | Managing for the sustained success of an organization — A quality management approach |
| 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 9001:2015 | Quality management systems — Requirements |
| ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
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