UNI EN ISO 11737-1 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
30-08-2022
01-01-2006
PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 ELEMENTI DEL SISTEMA DI GESTIONE PER LA QUALITA
5 SELEZIONE DEL PRODOTTO
6 METODI PER LA DETERMINAZIONE E LA CARATTERIZZAZIONE
MICROBICA DELLA CARICA MICROBIOLOGICA
7 CONVALIDA DEL METODO PER LA DETERMINAZIONE DELLA
CARICA MICROBIOLOGICA
8 DETERMINAZIONE SISTEMATICA DELLA CARICA
MICROBIOLOGICA E INTERPRETAZIONE DEI DATI
9 MANTENIMENTO DELLA VALIDITA DEL METODO DI
DETERMINAZIONE DELLA CARICA MICROBIOLOGICA
APPENDICE A (informativa) - GUIDA PER LA DETERMINAZIONE DI
UNA POPOLAZIONE DI MICRORGANISMI SUL PRODOTTO
APPENDICE B (informativa) - GUIDA SUI METODI DI DETERMINAZIONE
DELLA CARICA MICROBIOLOGICA
APPENDICE C (informativa) - CONVALIDA DEI METODI PER LA CARICA
MICROBIOLOGICA
APPENDICE ZA (informativa) - RAPPORTO TRA LA PRESENTE NORMA
EUROPEA E I REQUISITI ESSENZIALI DELLE DIRETTIVE
UE 90/385/CEE CONCERNENTE I DISPOSITIVI MEDICI
IMPIANTABILI ATTIVI, 93/42/CEE CONCERNENTE I
DISPOSITIVI MEDICI E 98/79/CEE CONCERNENTE I
DISPOSITIVI MEDICO-DIAGNOSTICI IN VITRO
BIBLIOGRAFIA
Describes requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package.
| DevelopmentNote |
Supersedes UNI EN 1174-1, UNI EN 1174-2 and UNI EN 1174-3. (07/2006)
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| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 11737-1:2018 | Identical |
| NBN EN ISO 11737-1 : 2006 COR 2009 | Identical |
| BS EN ISO 11737-1:2006 | Identical |
| DIN EN ISO 11737-1:2009-09 | Identical |
| I.S. EN ISO 11737-1:2006 | Identical |
| ISO 11737-1:2006 | Identical |
| UNE-EN ISO 11737-1:2007 | Identical |
| ONORM EN ISO 11737-1 : 2011 | Identical |
| SN EN ISO 11737-1 : 2006 CORR 2009 | Identical |
| NS EN ISO 11737-1 : 2018 | Identical |
| NEN EN ISO 11737-1 : 2018 | Identical |
| I.S. EN ISO 11737-1:2018&LC:2018 | Identical |
| NF EN ISO 11737-1 : 2018 | Identical |
| 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 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 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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 |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO/TR 7871:1997 | Cumulative sum charts Guidance on quality control and data analysis using CUSUM techniques |
| 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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