UNI EN ISO 11737-1 : 2006

Name: UNI EN ISO 11737-1 : 2006
Brand: UNI

Superseded

View Superseded by

STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS

Superseded date

08-30-2022

Published date

01-01-2006

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 11737-1:2018
Supersedes	UNI EN 1174-1 : 1996 UNI EN 1174-2 : 1998 UNI EN 1174-3 : 1998

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
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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
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ISO/TR 7871:1997	Cumulative sum charts Guidance on quality control and data analysis using CUSUM techniques
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