Name: UNI EN ISO 11737-2 : 2010
Brand: UNI

UNI EN ISO 11737-2 : 2010

Superseded

STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS

Superseded date

30-08-2022

Published date

01-01-2010

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 DELLA QUALITA
5 SELEZIONE DEL PRODOTTO
6 METODI DI ESECUZIONE DELLE PROVE DI STERILITA
7 VALUTAZIONE DEL METODO DI ESECUZIONE DELLE PROVE DI
  STERILITA
8 MANTENIMENTO DEL METODO DI ESECUZIONE DELLE PROVE DI
  STERILITA
APPENDICE A (informativa) - GUIDA ALLE PROVE DI STERILITA
  ESEGUITE NELLA CONVALIDA E NEL MANTENIMENTO DI UN PROCESSO
  DI STERILIZZAZIONE
APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE NORMA
  EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE 90/385/CEE
  CONCERNENTE I DISPOSITIVI MEDICI IMPIANTABILI ATTIVI
APPENDICE ZB (informativa) - RAPPORTO FRA LA PRESENTE NORMA
  EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE 93/42/CEE
  CONCERNENTE I DISPOSITIVI MEDICI
APPENDICE ZC (informativa) - RAPPORTO FRA LA PRESENTE NORMA
  EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE 98/79/CEE
  CONCERNENTE I DISPOSITIVI MEDICO-DIAGNOSTICI IN VITRO
BIBLIOGRAFIA

Describes the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing.

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 11737-2:2021
Supersedes	UNI EN ISO 11737-2 : 2001

Standards	Relationship
NF EN ISO 11737-2 : 2010	Identical
SN EN ISO 11737-2 : 2010	Identical
BS EN ISO 11737-2:2009	Identical
UNE-EN ISO 11737-2:2010	Identical
EN ISO 11737-2:2009	Identical
DIN EN ISO 11737-2:2010-04	Identical
NBN EN ISO 11737-2 : 2010	Identical
NS EN ISO 11737-2 : 2009	Identical
ONORM EN ISO 11737-2 : 2010	Identical
ISO 11737-2:2009	Identical
NEN EN ISO 11737-2 : 2009	Identical
I.S. EN ISO 11737-2:2009	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 11737-1:2006	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 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 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/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 14644-7:2004	Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 14644-1:2015	Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14644-4:2001	Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
ISO/TS 11135-2:2008	Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
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 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