UNI EN ISO 14937 : 2009
Current
The latest, up-to-date edition.
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
11-26-2009
PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 ELEMENTI DEL SISTEMA DI GESTIONE DELLA QUALITA
5 CARATTERIZZAZIONE DELL'AGENTE STERILIZZANTE
6 CARATTERIZZAZIONE DI PROCESSO E APPARECCHIATURE
7 DEFINIZIONE DEL PRODOTTO
8 DEFINIZIONE DEL PROCESSO
9 CONVALIDA
10 MONITORAGGIO E CONTROLLO SISTEMATICO
11 RILASCIO DEL PRODOTTO DALLA STERILIZZAZIONE
12 MANTENIMENTO DELL'EFFICACIA DEL PROCESSO
APPENDICE A (normativa) - FATTORI DA CONSIDERARE NELLA
SELEZIONE DEI MICRORGANISMI PER LA DIMOSTRAZIONE
DELL'EFFICACIA MICROBICIDA
APPENDICE B (normativa) - APPROCCIO 1 - DEFINIZIONE DEL
PROCESSO BASATA SULL'INATTIVAZIONE DELLA
POPOLAZIONE MICROBICA NEL SUO STATO NATURALE
APPENDICE C (normativa) - APPROCCIO 2 - DEFINIZIONE DEL
PROCESSO BASATA SULL'INATTIVAZIONE DI MICRORGANISMI
DI RIFERIMENTO E SULLE CONOSCENZE DELLA CARICA
MICROBIOLOGICA
APPENDICE D (normativa) - APPROCCIO 3 - DEFINIZIONE DEL
PROCESSO CONSERVATIVO BASATO SULL'INATTIVAZIONE
DEI MICRORGANISMI DI RIFERIMENTO
APPENDICE E (informativa) - GUIDA ALL'APPLICAZIONE DELLA
PRESENTE NORMA INTERNAZIONALE
APPENDICE ZA (informativa) - RAPPORTO TRA LA PRESENTE NORMA
EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA
UE 90/385/CEE CONCERNENTE I DISPOSITIVI MEDICI
IMPIANTABILI ATTIVI
APPENDICE ZB (informativa) - RAPPORTO TRA LA PRESENTE NORMA
EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA
UE 93/42/CEE CONCERNENTE I DISPOSITIVI MEDICI
APPENDICE ZC (informativa) - RAPPORTO TRA LA PRESENTE NORMA
EUROPEA E I REQUISITI ESSENZIAL I DELLA DIRETTIVA
UE 98/79/CEE CONCERNENTE I DISPOSITIVI MEDICI
DIAGNOSTICI IN VITRO
BIBLIOGRAFIA
Describes general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| UNE-EN ISO 14937:2010 | Identical |
| SN EN ISO 14937:2010 | Identical |
| ISO 14937:2009 | Identical |
| NBN EN ISO 14937 : 2009 | Identical |
| NEN EN ISO 14937 : 2009 | Identical |
| EN ISO 14937:2009 | Identical |
| NF EN ISO 14937 : 2009 | Identical |
| BS EN ISO 14937:2009 | Identical |
| I.S. EN ISO 14937:2009 | Identical |
| NS EN ISO 14937 : 2009 | Identical |
| DIN EN ISO 14937:2010-03 | Identical |
| IEC 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| 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 |
| 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 |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| 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 (TSE) agents |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 14040:2006 | Environmental management Life cycle assessment Principles and framework |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| 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 |
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