I.S. EN 13544-3:2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
Hardcopy , PDF
English
03-11-2001
28-09-2009
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
1 Scope
2 Normative references
3 Terms and definition
4 Oxygen supply
5 Connections
6 Delivered oxygen concentration
7 Marking and identification
8 Information supplied by the manufacturer
9 Usability
10 Clinical evaluation
Annex A (normative) - Method of test for delivered oxygen
concentration
Annex B (informative) - Rationale
Annex C (informative) - Colour coding
Annex ZA (informative) - Relationship between this European
Standard and the Essential
Requirements of EU Directive
93/42/EEC
Bibliography
Defines minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients.
| DevelopmentNote |
2001 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (10/2009)
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| BS EN 13544-3 : 2001 | Identical |
| NS EN 13544-3 : 2001 + A1 2009 | Identical |
| NBN EN 13544-3 : 2001 + A1 2009 | Identical |
| EN 13544-3:2001+A1:2009 | Identical |
| NEN EN 13544-3 : 2001 + A1 2009 | Identical |
| DIN EN 13544-3:2010-01 | Identical |
| NF EN 13544-3 : 2002 + A1 2009 | Identical |
| ONORM EN 13544-3 : 2010 | Identical |
| UNE-EN 13544-3:2001 | Identical |
| DIN EN 13544-3:2001-12 | Equivalent |
| EN 738-1:1997/A1:2002 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| BS 381C(1988) : LATEST | SPECIFICATION FOR COLOURS FOR IDENTIFICATION, CODING AND SPECIAL PURPOSES |
| EN ISO 4135:2001 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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