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UNI/TR 11408 : 2011

UNI/TR 11408 : 2011

Current

Current

The latest, up-to-date edition.

GUIDE TO DESIGN, DEVELOPMENT AND CONTROL OF A RECONDITION PROCESS FOR REUSABLE MEDICAL DEVICES THAT SHALL BE STERILIZED BY STEAM

Published date

03-03-2011

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 PROCESSO DI RICONDIZIONAMENTO DI DM RIUTILIZZABILI
   STERILIZZABILI A VAPORE
5 DECONTAMINAZIONE
6 LAVAGGIO
7 DISINFEZIONE
8 ASCIUGATURA
9 MONTAGGIO E CONTROLLO DEL DM
10 RICOMPOSIZIONE DEL KIT
11 CONFEZIONAMENTO
14 RILASCIO DEL DM RICONDIZIONATO
15 MOVIMENTAZIONE E STOCCAGGIO DEI DM STERILI
16 PERSONALE
17 RESPONSABILITA CHIAVE
18 FORMAZIONE E COMPETENZE
19 AMBIENTI
20 MANUTENZIONE DELLE APPARECCHIATURE E DEI DM
21 CONTROLLI E VERIFICHE PERIODICHE
22 CONVALIDE
23 DOCUMENTAZIONE
25 RIESAME DEL PROCESSO
26 TRACCIABILITA
APPENDICE A (informativa) - CRITERI DI CONFIGURAZIONE E
   DIMENSIONAMENTO STRUTTURALE E TECNOLOGICO DI UN IMPIANTO
   DI RICONDIZIONAMENTO
APPENDICE B (informativa) - NORME COMPORTAMENTALI

Committee
CT 44
DocumentType
Technical Report
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current

UNI EN ISO 14644-3 : 2006 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
UNI EN 556-1 : 2002 Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Requirements for terminally sterilized medical devices
UNI EN ISO 11607-2 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
UNI EN 13060 : 2010 SMALL STEAM STERILIZERS
UNI EN ISO 14644-1 : 2001 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - CLASSIFICATION OF AIR CLEANLINESS
UNI EN ISO 14644-2 : 2001 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: MONITORING TO PROVIDE EVIDENCE OF CLEANROOM PERFORMANCE RELATED TO AIR CLEANLINESS BY PARTICLE CONCENTRATION
UNI EN ISO 17665-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
UNI EN ISO 13485 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
UNI EN ISO 15882 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
UNI EN 285 : 2009 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
UNI EN ISO 11140-1 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
UNI EN 14971 : 2006 TEXTILES - KNITTED FABRICS - DETERMINATION OF NUMBER OF STITCHES PER UNIT LENGTH AND UNIT AREA
UNI EN ISO 11607-1 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

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