BS EN ISO 15883-1 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
29-08-2020
01-01-2009
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 |
LBI/35
|
| DevelopmentNote |
Supersedes BS 2745-1(1993) (05/2006) Supersedes 99/124125 DC. (06/2006) 2009 Editon Re-issued in September 2014 & incorporates AMD 1 2014. Supersedes 12/30252545 DC. (09/2014)
|
| DocumentType |
Standard
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| SN EN ISO 15883-1 : 2009 AMD 1 2014 | Identical |
| UNI EN ISO 15883-1 : 2014 | 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 |
| 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 |
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