I.S. EN ISO 15883-1:2009/A1:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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/Amd 1:2014)
Hardcopy , PDF
English
06-08-2014
16-05-2025
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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) A0 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
This part of ISO 15883 specifies 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 |
TC 198
|
| DocumentType |
Standard
|
| Pages |
110
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO EN 285:1996, EN 1822-1:1998
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 15883-1:2006/Amd 1:2014 | Identical |
| 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 |
| EN 1717:2000 | Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow |
| ISO 10993-18:2005 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| ASTM E 2314 : 2003 | Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test) |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 13485:2003 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 9000:2000 | Quality management systems — Fundamentals and vocabulary |
| ISO 9001:2000 | Quality management systems — Requirements |
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