Name: UNI EN ISO 14937 : 2009
Brand: UNI

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

Published date

11-26-2009

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 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	UNI EN ISO 14937 : 2002

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