EN ISO 15883-1:2009/A1:2014
Current
Current
The latest, up-to-date edition.
WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
Published date
07-16-2014
Publisher
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical and process requirements
6 Testing for conformity
7 Documentation
8 Information to be supplied by the manufacturer
9 Marking, labelling and packaging
10 Information to be requested from the purchaser by the
supplier of the WD
Annex A (informative) - Test programme
Annex B (informative) - A[O] concept - Comparative lethality
of moist heat processes
Annex C (normative) - Test methods for the detection and
assessment of residual proteinaceous
contamination
Annex D (normative) - Microbiological recovery medium for
estimation of bacterial contamination
of water
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical
devices
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 |
CEN/TC 102
|
| DevelopmentNote |
Supersedes PREN ISO 15883-1. (06/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 15883-1:2006/Amd 1:2014 | Identical |
| UNI EN ISO 15883-1 : 2014 | Identical |
| DIN EN ISO 15883-1:2014-10 | Identical |
| PN EN ISO 15883-1 : 2010 AMD 1 2014 | Identical |
| NS EN ISO 15883-1 : 2009 AMD 1 2014 | Identical |
| BS EN ISO 15883-1:2009+A1:2014 | Identical |
| UNE-EN ISO 15883-1:2009 | Identical |
| UNE-EN ISO 15883-1:2009/A1:2014 | Identical |
| I.S. EN ISO 15883-1:2009&A1:2014 | Identical |
| SN EN ISO 15883-1 : 2009 AMD 1 2014 | Identical |
| BS EN ISO 15883-1 : 2009 | Identical |
| NF 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 |
| DIN EN ISO 15883-7 E : 2016 | WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016) |
| ISO 15883-7:2016 | Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment |
| PREN 285 : DRAFT 2013 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| VDI 5700 Blatt 1:2015-04 | Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control |
| 12/30248648 DC : DRAFT AUG 2012 | BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES |
| I.S. EN 285:2015 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| BS EN ISO 15883-7:2016 | Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment |
| 13/30278676 DC : 0 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| I.S. EN 13060:2014 | SMALL STEAM STERILIZERS |
| DIN EN 1639:2010-02 | Dentistry - Medical devices for dentistry - Instruments |
| BS EN 1639:2009 | Dentistry. Medical devices for dentistry. Instruments |
| I.S. EN 1639:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| VDI 2083 Blatt 18:2012-01 | Cleanroom technology - Biocontamination control |
| 08/30184602 DC : DRAFT SEP 2008 | BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| DIN EN 16442 E : 2015 | CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
| EN 13060:2014 | Small steam sterilizers |
| I.S. EN ISO 15883-7:2016 | WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016) |
| I.S. EN 16442:2015 | CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
| DIN EN 13060:2015-03 | SMALL STEAM STERILIZERS |
| DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
| UNI EN 1639 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| BS EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| DIN EN 16442:2015-05 | CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
| UNE-EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| BS EN 13060 : 2014 | SMALL STEAM STERILIZERS |
| BS EN 285:2015 | Sterilization. Steam sterilizers. Large sterilizers |
| EN ISO 15883-7:2016 | Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016) |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| EN 16442:2015 | Controlled environment storage cabinet for processed thermolabile endoscopes |
| DIN EN ISO 15883-7:2016-10 | WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016) |
| UNE-EN ISO 15883-7:2016 | Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016) |
| UNE-EN 13060:2015 | Small steam sterilizers |
| UNE-EN 285:2016 | Sterilization - Steam sterilizers - Large sterilizers |
| 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 |
| 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 |
| 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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