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I.S. EN 14180:2014

Current
Current

The latest, up-to-date edition.

STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Preview

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.

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
UNI EN 14180 : 2014 Identical
SN EN 14180 : 2014 Identical
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
DIN EN 14180:2003-10 Identical
UNE-EN 14180:2004 Identical

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EN 60204-1 : 2006 COR 2010 SAFETY OF MACHINERY - ELECTRICAL EQUIPMENT OF MACHINES - PART 1: GENERAL REQUIREMENTS

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