UNI EN ISO 10993-1 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
08-26-2022
01-01-2010
PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 PRINCIPI GENERALI DI APPLICAZIONE ALLA VALUTAZIONE
BIOLOGICA DEI DISPOSITIVI MEDICI
5 CATEGORIZZAZIONE DEI DISPOSITIVI MEDICI
6 PROCESSO DI VALUTAZIONE BIOLOGICA
7 INTERPRETAZIONE DEI DATI DELLA VALUTAZIONE BIOLOGICA
E DELLA VALUTAZIONE COMPLESSIVA SULLA SICUREZZA
BIOLOGICA
APPENDICE A (informativa) - PROVE SULLA VALUTAZIONE BIOLOGICA
APPENDICE B (informativa) - GUIDA AL PROCESSO DI GESTIONE DEL
RISCHIO
APPENDICE C (informativa) - PROCEDIMENTO CONSIGLIATO PER
L'ANALISI DELLA LETTERATURA
APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE NORMA
EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE
93/42/CEE CONCERNENTE I DISPOSITIVI MEDICI
APPENDICE ZB (informativa) - RAPPORTO FRA LA PRESENTE NORMA
EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE
90/385/CEE CONCERNENTE I DISPOSITIVI MEDICI IMPIANTABILI
ATTIVI
BIBLIOGRAFIA
Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device.
| DevelopmentNote |
Supersedes UNI EN 30993-1 (07/1999)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| SN EN ISO 10993-1 : 2010 CORR 2010 | Identical |
| BS EN ISO 10993-1 : 2009-10 | Identical |
| NS EN ISO 10993-1 : 2009 COR 2010 | Identical |
| EN ISO 10993-1:2009 | Identical |
| NEN EN ISO 10993-1 : 2009 C1 2010 | Identical |
| I.S. EN ISO 10993-1:2009+AC:2010 | Identical |
| ISO 10993-1:2009 | Identical |
| NBN EN ISO 10993-1 : 2009 COR 2010 | Identical |
| UNE-EN ISO 10993-1:2010 | Identical |
| NF EN ISO 10993-1 : 2010 | Identical |
| ONORM EN ISO 10993-1 : 2011 | Identical |
| DIN EN ISO 10993-1:2010-04 | Identical |
| UNI 11533 : 2014 | MASS-PRODUCED ORTHOPEDIC FOOTWEAR DESIGNED FOR FOOT ORTHOTIC - SAFETY AND PERFORMANCE REQUIREMENTS AND TEST METHODS |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| 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 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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