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I.S. EN 13544-3:2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

28-09-2009

Language(s)

English

Published date

03-11-2001

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
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Superseded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

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
EN 980:2008 Symbols for use in the labelling of medical devices

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