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UNI EN ISO 15883-1 : 2014

Current
Current

The latest, up-to-date edition.

WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
Published date

10-09-2014

PREMESSA ALLA NORMA UNI EN ISO 15883-1
PREMESSA ALL'AGGIORNAMENTO A1
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 REQUISITI DI PRESTAZIONE
5 REQUISITI MECCANICI E DI PROCESSO
6 PROVE DI CONFORMITA
7 DOCUMENTAZIONE
8 INFORMAZIONI FORNITE DAL FABBRICANTE
9 MARCATURA, ETICHETTATURA E IMBALLAGGIO
10 INFORMAZIONI RICHIESTE ALL'ACQUIRENTE
   DA PARTE DEL FORNITORE DELL'APPARECCHIO
   DI LAVAGGIO E DISINFEZIONE
APPENDICE A (informativa) - PROGRAMMA DI PROVA
APPENDICE B (informativa) - CONCETTO A[0] - LETALITA
            COMPARATIVA DEI PROCESSI A CALORE UMIDO
APPENDICE C (normativa) - METODI DI PROVA PER LA
            RIVELAZIONE E VALUTAZIONE DELLA
            CONTAMINAZIONE PROTEICA RESIDUA
APPENDICE D (normativa) - TERRENO DI COLTURA PER LA
            STIMA DELLA CONTAMINAZIONE BATTERICA
            DELL'ACQUA
APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE
             NORMA EUROPEA E I REQUISITI ESSENZIALI
             DELLA DIRETTIVA UE 93/42/CEE
BIBLIOGRAFIA

Describes general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

Committee
CT 44
DevelopmentNote
Italian version issued in NOVEMBER 2014. (11/2014)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
IEC 60073:2002 Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
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 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 1717:2000 Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow
ISO 12100:2010 Safety of machinery — General principles for design — Risk assessment and risk reduction
ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
IEC 61010-2-045:2000 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields
ISO 13849-2:2012 Safety of machinery — Safety-related parts of control systems — Part 2: Validation
DIN 58955-3:1998-09 DECONTAMINATION-APPARATUS IN THE MEDICAL FIELD - EFFICIENCY TESTING
IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
DIN 10510:2013-10 FOOD HYGIENE - COMMERCIAL DISHWASHING WITH MULTITANK-TRANSPORTDISHWASHERS - HYGIENE REQUIREMENTS, PROCEDURE TESTING
IEC 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
ISO 228-1:2000 Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
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
1997/23/EC : 1997 DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT

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