• There are no items in your cart

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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

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Superseded date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

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Superseded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

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

View more information
€37.00
Excluding VAT

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.