EN 13544-3:2001/prA1
(Amendment)Respiratory therapy equipment - Part 3: Air entrainment devices
Respiratory therapy equipment - Part 3: Air entrainment devices
Atemtherapiegeräte - Teil 3: Luftbeimischgeräte
Appareils de thérapie respiratoire - Partie 3 : Dispositifs d'entrainement d'air
Dihalna oprema za zdravljenje - 3. del: Vhodne naprave za zrak
General Information
- Status
- Not Published
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 2 - Lung ventilators
- Current Stage
- 5060 - Closure of Vote - Formal Approval
- Start Date
- 29-Jun-2009
- Completion Date
- 29-Jun-2009
Relations
- Merged Into
EN 13544-3:2001+A1:2009 - Respiratory therapy equipment - Part 3: Air entrainment devices - Effective Date
- 04-Jul-2009
- Effective Date
- 22-Dec-2008
Overview
EN 13544-3:2001/prA1 (CEN draft amendment, Jan 2009) updates the European standard for respiratory therapy equipment - Part 3: air entrainment devices. Prepared by CEN/TC 215, this prA1 amendment modifies the original EN 13544-3:2001 to add regulatory, usability and clinical evaluation requirements, and to align the standard with relevant medical device directives. The amendment supports compliance with the Essential Requirements of Directive 93/42/EEC for medical devices when adopted by CEN members.
Key topics and technical requirements
This amendment focuses on documentation, safety information and processes that manufacturers and assessors must address for air entrainment devices (used in respiratory therapy):
- Standards references: Adds applicability of usability and human factors standards - EN 60601-1-6 and EN 62366 - for usability engineering of medical devices.
- Manufacturer identification and labelling:
- Require name/address of authorized representative if manufacturer has no EU registered place of business.
- For single-use devices, manufacturers must disclose risks of reuse in the instructions for use.
- Instructions for use:
- Must include date of issue or latest revision.
- Label parts that contain phthalates when they contact the patient; if intended for children or pregnant/nursing women, residual risks must be stated.
- Notes cautioning about substances classified as carcinogenic, mutagenic or toxic to reproduction.
- New Clauses:
- Clause 9 - Usability: Manufacturers must perform a usability engineering process to address risks from poor usability (referencing IEC/EN usability standards). Compliance checked via usability engineering file inspection.
- Clause 10 - Clinical evaluation: A clinical evaluation must be performed and documented in the risk management file; compliance checked by inspection.
- Regulatory alignment: Modifies Annex ZA to map standard clauses to the Essential Requirements of Directive 93/42/EEC and warns other directives may apply.
Applications and users
This amendment is relevant to:
- Manufacturers of air entrainment devices and other respiratory therapy equipment seeking CE conformity.
- Regulatory affairs and compliance teams preparing technical documentation for the EU market.
- Notified bodies and test laboratories assessing conformity to EN 13544-3 and Directive 93/42/EEC.
- Design and usability engineers implementing usability engineering and clinical evaluation in device development.
Related standards
- EN 13544-3:2001 (original)
- EN 60601-1-6 / IEC 60601-1-6 (usability/human factors)
- EN 62366 (application of usability engineering to medical devices)
- Directive 93/42/EEC (Medical Devices Directive) - essential requirements mapping
Keywords: EN 13544-3, air entrainment devices, respiratory therapy equipment, medical device standard, usability engineering, clinical evaluation, phthalates labelling, Directive 93/42/EEC, CEN/TC 215.
Frequently Asked Questions
EN 13544-3:2001/prA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Respiratory therapy equipment - Part 3: Air entrainment devices". This standard covers: Respiratory therapy equipment - Part 3: Air entrainment devices
Respiratory therapy equipment - Part 3: Air entrainment devices
EN 13544-3:2001/prA1 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13544-3:2001/prA1 has the following relationships with other standards: It is inter standard links to EN 13544-3:2001+A1:2009, EN 13544-3:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13544-3:2001/prA1 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 13544-3:2001/prA1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2009
Dihalna oprema za zdravljenje - 3. del: Vhodne naprave za zrak
Respiratory therapy equipment - Part 3: Air entrainment devices
Atemtherapiegeräte - Teil 3: Luftbeimischgeräte
Appareils de thérapie respiratoire - Partie 3 : Dispositifs d'entrainement d'air
Ta slovenski standard je istoveten z: EN 13544-3:2001/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
FINAL DRAFT
EN 13544-3:2001
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
January 2009
ICS 11.040.10
English Version
Respiratory therapy equipment - Part 3: Air entrainment devices
Appareils de thérapie respiratoire - Partie 3 : Dispositifs Atemtherapiegeräte - Teil 3: Luftbeimischgeräte
d'entrainement d'air
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 215.
This draft amendment A1, if approved, will modify the European Standard EN 13544-3:2001. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other language made
by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
: This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
Warning
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13544-3:2001/prA1:2009: E
worldwide for CEN national Members.
Contents Page
Foreword . 3
1 Modification to Clause 2 . 4
2 Modifications to Clause 7 . 4
3 Modifications to Clause 8 . 4
4 Addition of Clauses 9 and 10 . 4
5 Modifications to Annex ZA . 5
Foreword
This document (EN 13544-3:2001/prA1:2009) has been prepared by Technical Committee
CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI.
This document is currently submitte
...
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