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UNI EN ISO 11737-1 : 2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date

30-08-2022

Published date

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)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

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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