SIST EN 794-3:2000/kprA2:2009
(Amendment)Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
The scope given in clause 1 of EN 60601-1:1990 applies with the following addition:
1.101 R) This part of this European Standard specifies requirements for ventilators, driven by a power source and intended for emergency and transport use.
This covers a range of devices, from relatively simple ventilators intended, primarily, for use with a face mask and for limited periods (e.g. gas powered ventilators) through to devices for pre-planned longer term use. !This includes gas-powered resuscitators, which are generally used by first responders."
This part does not cover operator-powered ventilators (i.e. manual resuscitators).
Ventilators aboard aircraft are likely to be subject to additional requirements and national/international regulations.
Additional parts, e.g. concerning lung ventilators for critical care (see EN 794-1), home care ventilators (see EN 794-2), operator powered resuscitators and recent developments such as jet and very high frequency ventilation and oscillation are published or under consideration.
Lungenbeatmungsgeräte - Teil 3: Besondere Anforderungen an Notfall- und Transportbeatmungsgeräte
Ventilateurs pulmonaires - Partie 3: Règles particulières pour les ventilateurs d'urgence et de transport
Pljučni ventilatorji - 3. del: Posebne zahteve za ventilatorje za nujno medicinsko pomoč in prevoz
General Information
Relations
Overview
SIST EN 794-3:2000/kprA2:2009 is a European Standard published by CEN, specifically addressing lung ventilators for emergency and transport use. It defines the particular requirements for ventilators powered by an external energy source, such as gas-powered or electric ventilators, intended primarily for short-term use, including devices used by first responders. Unlike operator-powered devices (manual resuscitators), this standard focuses on mechanically-driven ventilators suitable for use in emergency scenarios and patient transport.
The standard is an amendment to the original EN 794-3:1998 and incorporates additional safety, usability, and documentation requirements to align with modern regulations and technology advances. It supports essential requirements under European medical device directives, especially Directive 93/42/EEC.
Key Topics
Scope and Application
The standard covers ventilators designed for emergency and transport applications, including gas-powered resuscitators mainly used by first responders. It excludes manual/operator-powered resuscitators and acknowledges that ventilators used aboard aircraft may be subject to further regulations.Safety and Performance Requirements
Amendments focus on manufacturer responsibilities such as clear labeling, risk disclosure-especially for single-use devices and substances like phthalates-and compliance with software development standards (EN 62304).Clinical Evaluation and Risk Management
The document mandates clinical evaluation as an integral part of risk management, requiring documented evidence to ensure safety and effectiveness in real-life use.Usability Engineering
Compliance with usability standards IEC 60601-1-6 and EN 62366 is enforced to minimize user error and improve device operability, which is critical in emergencies.Labeling and Documentation
Manufacturers must provide detailed instructions, including revision dates and risk information associated with material components, ensuring transparency regarding potential hazards.Regulatory Alignment
The standard aligns with EU regulations, providing a presumption of conformity to essential medical device requirements detailed in Directive 93/42/EEC. It also references compliance with machinery directive requirements where applicable.
Applications
Emergency Medical Services (EMS)
Portable ventilators certified to EN 794-3 are suitable for paramedics and first responders providing respiratory support during ambulance transport or at emergency scenes.Patient Transport
Devices meeting this standard can be safely used during intra-hospital patient transfers or transport between healthcare facilities, supporting respiratory function without compromising patient safety.Pre-Hospital and Field Settings
Gas-powered and electrically-driven transport ventilators certified under this standard are reliable in non-clinical environments where quick deployment is essential.Specialized Environments
Transport ventilators conforming to this standard are designed to meet auxiliary requirements for aviation or military medical operations, though additional regulations may apply.
Related Standards
- EN 794-1 – Lung Ventilators for Critical Care: Covers ventilators intended for prolonged and intensive therapy.
- EN 794-2 – Lung Ventilators for Home Care: Focuses on devices used in residential settings for chronic respiratory support.
- IEC 60601-1-6 – Medical Electrical Equipment Usability: Addresses usability engineering requirements.
- EN 62304 – Medical Device Software Life-cycle Processes: Specifies software development and maintenance requirements.
- EN 62366 – Application of Usability Engineering to Medical Devices: Ensures user interface design reduces risks.
By adhering to SIST EN 794-3:2000/kprA2:2009, manufacturers ensure their emergency and transport ventilators meet stringent European safety, performance, and usability criteria, enabling effective and safe respiratory care in critical situations.
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2009
3OMXþQLYHQWLODWRUMLGHO 3RVHEQH]DKWHYH]DYHQWLODWRUMH]DQXMQRPHGLFLQVNR
SRPRþLQSUHYR]
Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Lungenbeatmungsgeräte - Teil 3: Besondere Anforderungen an Notfall- und
Transportbeatmungsgeräte
Ventilateurs pulmonaires - Partie 3: Règles particulières pour les ventilateurs d'urgence
et de transport
Ta slovenski standard je istoveten z: EN 794-3:1998/prA2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.160 3UYDSRPRþ First aid
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
FINAL DRAFT
EN 794-3:1998
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
January 2009
ICS 11.040.10; 11.160
English Version
Lung ventilators - Part 3: Particular requirements for emergency
and transport ventilators
Ventilateurs pulmonaires - Partie 3: Règles particulières Lungenbeatmungsgeräte - Teil 3: Besondere
pour les ventilateurs d'urgence et de transport Anforderungen an Notfall- und Transportbeatmungsgeräte
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 A2, if approved, will modify the European Standard EN 794-3:1998. 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
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 794-3:1998/prA2:2009: E
worldwide for CEN national Members.
Contents Page
Foreword . 3
1 Modification to Clause 2 . 4
2 Modification to 4.1 . 4
3 Modifications to Clause 6 . 4
4 Modification to Clause 48 . 5
5 Modification to Clause 54 . 5
6 Modifications to Annex ZA . 5
Foreword
This document (EN 794-3:1998/prA2:2009) 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 submitted to the Unique Acceptance Procedure.
This document has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements
of EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of
this document.
1 Modification to Clause 2
Add the following references:
"EN 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance – Collateral Standard: Usability
EN 62304, Medical device software - Software life-cycle processes
EN 62366, Medical devices - Application of usability engineering to medical devices".
2 Modification to 4.1
Add the following to clause 4.1:
"3.10 Clinical evaluation
A clinical evaluation shall be performed and documented in the risk management file.
Check compliance by inspection of the risk management file."
3 Modifications to Clause
...
Frequently Asked Questions
SIST EN 794-3:2000/kprA2:2009 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators". This standard covers: The scope given in clause 1 of EN 60601-1:1990 applies with the following addition: 1.101 R) This part of this European Standard specifies requirements for ventilators, driven by a power source and intended for emergency and transport use. This covers a range of devices, from relatively simple ventilators intended, primarily, for use with a face mask and for limited periods (e.g. gas powered ventilators) through to devices for pre-planned longer term use. !This includes gas-powered resuscitators, which are generally used by first responders." This part does not cover operator-powered ventilators (i.e. manual resuscitators). Ventilators aboard aircraft are likely to be subject to additional requirements and national/international regulations. Additional parts, e.g. concerning lung ventilators for critical care (see EN 794-1), home care ventilators (see EN 794-2), operator powered resuscitators and recent developments such as jet and very high frequency ventilation and oscillation are published or under consideration.
The scope given in clause 1 of EN 60601-1:1990 applies with the following addition: 1.101 R) This part of this European Standard specifies requirements for ventilators, driven by a power source and intended for emergency and transport use. This covers a range of devices, from relatively simple ventilators intended, primarily, for use with a face mask and for limited periods (e.g. gas powered ventilators) through to devices for pre-planned longer term use. !This includes gas-powered resuscitators, which are generally used by first responders." This part does not cover operator-powered ventilators (i.e. manual resuscitators). Ventilators aboard aircraft are likely to be subject to additional requirements and national/international regulations. Additional parts, e.g. concerning lung ventilators for critical care (see EN 794-1), home care ventilators (see EN 794-2), operator powered resuscitators and recent developments such as jet and very high frequency ventilation and oscillation are published or under consideration.
SIST EN 794-3:2000/kprA2:2009 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment; 11.160 - First aid. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 794-3:2000/kprA2:2009 has the following relationships with other standards: It is inter standard links to SIST EN 794-3:2000+A2:2009, SIST EN 794-3:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 794-3:2000/kprA2:2009 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.
You can purchase SIST EN 794-3:2000/kprA2:2009 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...