UNI EN ISO 15883-1 : 2014
Current
The latest, up-to-date edition.
WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
09-10-2014
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 |
| Standards | Relationship |
| SN EN ISO 15883-1 : 2009 AMD 1 2014 | Identical |
| BS EN ISO 15883-1 : 2009 | Identical |
| DIN EN ISO 15883-1:2014-10 | Identical |
| NF EN ISO 15883-1 : 2009 AMD 1 2014 | Identical |
| NS EN ISO 15883-1 : 2009 AMD 1 2014 | Identical |
| I.S. EN ISO 15883-1:2009 | Identical |
| NBN EN ISO 15883-1 : 2009 AMD 1 2014 | Identical |
| NEN EN ISO 15883-1 : 2009 AMD 1 2014 | Identical |
| ISO 15883-1:2006 | Identical |
| UNE-EN ISO 15883-1:2009 | Identical |
| 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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