I.S. EN 14180:2014
Current
The latest, up-to-date edition.
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
Hardcopy , PDF
English
01-01-2014
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 Technical requirements
5 Process control
6 Performance requirements
7 Sound power and vibration
8 Packaging, marking and labelling
9 Information to be supplied by the manufacturer
10 Service and local environment
Annex A (normative) - Test methods
Annex B (normative) - Sterilizer classification and testing
Annex C (normative) - Test equipment
Annex D (normative) - Determination of formaldehyde residuals
in a filter indicator
Annex E (informative) - Formaldehyde residues on medical devices
Annex F (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
Bibliography
Describes requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
| DocumentType |
Standard
|
| Pages |
64
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN 14180:2014-09 | Identical |
| NS EN 14180 : 2014 | Identical |
| EN 14180:2014 | Identical |
| BS EN 14180:2014 | Identical |
| NF EN 14180 : 2014 | Identical |
| NEN EN 14180 : 2014 | Identical |
| NBN EN 14180 : 2014 | Identical |
| UNE-EN 14180:2014 | Equivalent |
| DIN EN 14180:2003-10 | Identical |
| UNE-EN 14180:2004 | Identical |