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SIST EN 794-3:2000/A1:2005

(Amendment)

Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

To amend EN 794-3 so as to include requirements for use with nitric oxide/ nitrogen mixtures

Lungenbeatmungsgeräte - Teil 3: Besondere Anforderungen an Notfall- und Transportbeatmungsgeräte

Ventilateurs pulmonaires - Partie 3 : Regles particulieres pour les ventilateurs d'urgence et de transport

Pljučni ventilatorji - 3. del: Posebne zahteve za ventilatorje za nujno medicinsko pomoč in prevoz

General Information

Status
Withdrawn
Publication Date
31-Aug-2005
Withdrawal Date
24-Aug-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
11.160 - First aid
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
25-Aug-2009
Due Date
17-Sep-2009
Completion Date
25-Aug-2009
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 794-3:1998/A1:2005 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

Relations

Consolidated By
SIST EN 794-3:2000+A2:2009 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
18-Jan-2023
Consolidated By
SIST EN 794-3:2000+A2:2009 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
19-Jan-2023
Consolidated By
SIST EN 794-3:2000+A2:2009 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
01-Oct-2009
Amends
SIST EN 794-3:2000 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
22-Dec-2008

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EN 794-3:2000/A1:2005
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 794-3:2000/A1:2005
01-september-2005
3OMXþQLYHQWLODWRUMLGHO3RVHEQH]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 : Regles particulieres pour les ventilateurs d'urgence
et de transport
Ta slovenski standard je istoveten z: EN 794-3:1998/A1:2005
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.160 3UYDSRPRþ First aid
SIST EN 794-3:2000/A1:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 794-3:2000/A1:2005

---------------------- Page: 2 ----------------------

SIST EN 794-3:2000/A1:2005
EUROPEAN STANDARD
EN 794-3:1998/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2005
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 amendment A1 modifies the European Standard EN 794-3:1998; it was approved by CEN on 25 May 2005.
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. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the Central Secretariat or to any CEN member.
This amendment exists 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 Central Secretariat has the same stat
...

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This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
–   intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
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–   intended for use in the EMS environment; and
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This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
–   intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
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–   intended for use in the EMS environment; and
–   intended for invasive or non-invasive ventilation.
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This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
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This document does not specify the requirements for the following:
–   ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
–   ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72[3].
–   ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‐2‐13[4].
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–   obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70[7].
–   operator-powered resuscitators, which are given in ISO 10651‐4[8].
–   gas-powered emergency resuscitators, which are given in ISO 10651‐5[9].
–   continuous positive airway pressure (CPAP) ME equipment .
–   high‐frequency jet ventilators (HFJVs), which are given ISO 80601-2-87[11].
–   high‐frequency oscillatory ventilators (HFOVs)[10], which are given ISO 80601-2-87[11].
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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."
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