NOVITÀ SU STANDARD EUROPEI PER DISPOSITIVI MEDICI
Il 27 luglio 2019 è terminata la fase di pubblica consultazione del documento “Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746” pubblicato lo scorso 26 giugno 2019 dalla Commissione Europea.
Tale bozza contiene un elenco di standard relativi a dispositivi medici e dispositivi medico- diagnostici in vitro che dovranno essere da revisionati ed elaborati ex novo in accordo ai requisiti e alle specifiche tecniche presenti nei Regolamenti UE 2017/745 e UE 2017/746.
Infatti, in vista della piena implementazione dell’MDR, il CEN (il comitato europeo di normazione) e il CENELEC (comitato europeo per la normazione elettrotecnica) dovranno pertanto aggiornare gli standard armonizzati ed elaborarne altri nuovi entro le tempiste prefissate dalla Commissione Europea. I comitati sopra citati dovranno riferire lo stato di avanzamento del loro lavoro alla Commissione presentando periodicamente relazioni annuali.
L’ESO (European standardisation organisation) prevede di adottare la maggior parte degli standard relativi ai dispositivi medici e IVD entro il 27 maggio 2024, con alcune eccezioni.
Per i dispositivi medici e IVD, alcuni standard saranno adottati entro il 2020, come:
| Standard | Data di adozione | Valido per DM | Valido per IVD |
| EN ISO 13485:2016+AC:2018 Medical devices – Quality management systems -Requirements for regulatory purposes | 26/05/2020 | X | X |
| EN ISO 14155:2011+AC:2011 Clinical investigation of medical devices for human subjects – Good clinical practice | 26/05/2020 | X | |
| EN ISO 14971:2012 Medical devices – Application of risk management to medical devices | 26/05/2020 | X | X |
| EN ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements | 26/05/2020 | X | X |
| EN 15986:2011 Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates | 26/05/2020 | X |
Solo per gli IVD, entro il 2021 saranno applicati i seguenti standard:
| Standard | Data di adozione |
| EN ISO 18113-1:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements | 30/09/2021 |
| EN ISO 18113-2:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use | 30/09/2021 |
| EN ISO 18113-3:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use | 30/09/2021 |
| EN ISO 18113-4:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing | 30/09/2021 |
| EN ISO 18113-5:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing | 30/09/2021 |
Invece, entro il 2022 sarà adottato il nuovo standard:
| Standard | Data di adozione |
| In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916) | 26/05/2022 |
Qui di seguito sono riportati nel dettaglio gli standard che saranno revisionati e che saranno elaborati entro il 2024.
STANDARD EUROPEI PER DISPOSITIVI MEDICI
Elenco degli standard esistenti che devono essere rivisti:
| Standard | Data di adozione |
|---|---|
| EN 556-1:2001+AC:2006 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices | 27/05/2024 |
| EN 556-2:2015 Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices | 27/05/2024 |
| EN ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process | 27/05/2024 |
| EN ISO 10993-3:2014 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | 27/05/2024 |
| EN ISO 10993-4:2017 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood | 27/05/2024 |
| EN ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | 27/05/2024 |
| EN ISO 10993-6:2016 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation | 27/05/2024 |
| EN ISO 10993-7:2008+AC:2009 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals | 27/05/2024 |
| EN ISO 10993-9:2009 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products | 27/05/2024 |
| EN ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization | 27/05/2024 |
| EN ISO 10993-11:2018 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity | 27/05/2024 |
| EN ISO 10993-12:2012 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials | 27/05/2024 |
| EN ISO 10993-13:2010 Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices | 27/05/2024 |
| EN ISO 10993-14:2009 Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics | 27/05/2024 |
| EN ISO 10993-15:2009 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys | 27/05/2024 |
| EN ISO 10993-16:2017 Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables | 27/05/2024 |
| EN ISO 10993-17:2009 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances | 27/05/2024 |
| EN ISO 10993-18:2009 Biological evaluation of medical devices – Part 18: Chemical characterization of materials | 27/05/2024 |
| EN ISO 11135:2014 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN ISO 11137-1:2015 Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose | 27/05/2024 |
| EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems | 27/05/2024 |
| EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes | 27/05/2024 |
| EN ISO 11737-1:2018 Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products | 27/05/2024 |
| EN ISO 11737-2:2009 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | 27/05/2024 |
| EN ISO 13408-1:2015 Aseptic processing of health care products – Part 1: General requirements | 27/05/2024 |
| EN ISO 13408-2:2018 Aseptic processing of health care products – Part 2: Filtration | 27/05/2024 |
| EN ISO 13408-3:2011 Aseptic processing of health care products – Part 3: Lyophilization | 27/05/2024 |
| EN ISO 13408-4:2011 Aseptic processing of health care products – Part 4: Clean-in-place technologies | 27/05/2024 |
| EN ISO 13408-6:2011+A1:2013 Aseptic processing of health care products – Part 6: Isolator systems | 27/05/2024 |
| EN ISO 13408-7:2015 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products | 27/05/2024 |
| EN ISO 14160:2011 Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN ISO 14630:2012 Non-active surgical implants – General requirements | 27/05/2024 |
| EN 14885:2018 Chemical disinfectants and antiseptics – Application of European standards for chemical disinfectants and antiseptics | 27/05/2024 |
| EN ISO 14937:2009 Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN ISO 20857:2013 Sterilization of health care products – Dry heat – Requirements for the development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management | 27/05/2024 |
| EN ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling | 27/05/2024 |
| EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy | 27/05/2024 |
| EN ISO 25424:2011 Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN 60601-1:2006 + AC:2010 + A1:2013+A12:2014 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | 27/05/2024 |
| EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests | 27/05/2024 |
| EN 60601-1-3:2008+AC:2010+A11:2016 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment | 27/05/2024 |
| EN 60601-1-6:2010+A1:2015 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability | 27/05/2024 |
| EN 60601-1-8:2007+AC:2010+A11:2017+prA2 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | 27/05/2024 |
| EN 60601-1-10:2008+A1:2015 Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controller | 27/05/2024 |
| EN 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | 27/05/2024 |
| EN 60601-1-12:2015 Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment | 27/05/2024 |
| EN 62304:2018 Medical device software – Software life-cycle processes | 27/05/2024 |
| EN 62366-1:2015+AC:2016 Medical devices – Application of usability engineering to medical devices | 27/05/2024 |
Elenco di nuovi standard che dovranno essere elaborati:
| Standard | Adozione |
| prEN ISO 10993-23 Biological evaluation of medical devices – Part 23: Determination of skin irritation of medical device extracts using Reconstructed human Epidermis (RhE) (ISO 10993-23) | 27/05/2024 |
| Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (ISO 14708-1) | 27/05/2024 |
| Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664-1) | 27/05/2024 |
| Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Medical devices not intended for direct patient contact (ISO 17664-2) | 27/05/2024 |
| prEN ISO 20417 Medical devices – Information to be provided by manufacturer (ISO 20417) | 27/05/2024 |
| Sharps injury protection – Requirements and test methods – Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908) | 27/05/2024 |
STANDARD EUROPEI PER DISPOSITIVI MEDICO-DIAGNOSTICO IN VITRO
Elenco degli standard esistenti che dovranno essere rivisti
| Standard | Data di adozione |
|---|---|
| EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes | 27/05/2024 |
| EN ISO 11737-1:2018 Sterilization of medical devices – Microbiological 27/5/2024 EN 10 EN methods – Part 1: Determination of a population of microorganisms on products | 27/05/2024 |
| EN ISO 11737-2:2009 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | 27/05/2024 |
| EN ISO 13408-1:2015 Aseptic processing of health care products – Part 1: General requirements | 27/05/2024 |
| EN ISO 13408-2:2018 Aseptic processing of health care products – Part 2: Filtration | 27/05/2024 |
| EN ISO 13408-3:2011 Aseptic processing of health care products – Part 3: Lyophilization | 27/05/2024 |
| EN ISO 13408-4:2011 Aseptic processing of health care products – Part 4: Clean-in-place technologies | 27/05/2024 |
| EN ISO 13408-5:2011 Aseptic processing of health care products – Part 5: Sterilization in place | 27/05/2024 |
| EN ISO 13408-6:2011+A1:2013 Aseptic processing of health care products – Part 6: Isolator systems | 27/05/2024 |
| EN ISO 13408-7:2015 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products | 27/05/2024 |
| EN 13532:2002 EN 11 EN General requirements for in vitro diagnostic medical devices for self-testing | 27/5/2024 |
| EN 13612:2002+AC:2002 Performance evaluation of in vitro diagnostic medical devices | 27/05/2024 |
| EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents | 27/05/2024 |
| EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices – Statistical aspects | 27/05/2024 |
| EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures | 27/05/2024 |
| EN ISO 14937:2009 Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN ISO 15193:2009 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for content and presentation of reference measurement procedures | 27/05/2024 |
| EN ISO 15194:2009 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for certified reference materials and the content of supporting documentation | 27/05/2024 |
| EN ISO 15197:2015 27/5/2024 EN 12 EN In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus | 27/05/2024 |
| EN ISO 17511:2003 In vitro diagnostic medical devices – requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples | 27/05/2024 |
| EN ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN ISO 20857:2013 Sterilization of health care products – Dry heat – Requirements for the development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN ISO 23640:2015 In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents | 27/05/2024 |
| EN ISO 25424:2011 Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices | 27/05/2024 |
| EN 62304:2018 Medical device software – Software life-cycle processes | 27/05/2024 |
| EN 62366-1:2015+AC:2016 Medical devices – Application of usability engineering to medical devices | 27/05/2024 |
Elenco di nuovi standard che dovranno essere elaborati:
| Standard | Data di adozione |
| Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664-1) | 27/05/2024 |
| Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Medical devices not intended for direct patient contact (ISO 17664-2) | 27/05/2024 |
| prEN ISO 20417 Medical devices – Information to be provided by manufacturer (ISO 20417) | 27/05/2024 |
Fonti
https://ec.europa.eu/docsroom/documents/36104?locale=en
