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SIST EN 794-3:2000

(Main)

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 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

Abschnitt 1 von EN 60601-1:1990 gilt in Verbindung mit folgender Ergänzung: 1.101 R) Dieser Teil dieser Europäischen Norm legt Anforderungen an Beatmungsgeräte fest, die energetisch betrieben werden und für Notfälle und Transport vorgesehen sind. Dieser Teil umfaßt eine Reihe von Geräten, angefangen von relativ einfachen Beatmungsgeräten, die in erster Linie mit einer Gesichtsmaske benutzt werden und für einen begrenzten Zeitraum vorgesehen sind (z.B. gasbetriebene Beatmungsgeräte), bis hin zu Geräten für den längerfristigen Gebrauch.

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

Le domaine d'application indiqué a l'article 1 de l'EN 60601-1:1990 s'applique, avec l'ajout suivant: 1.101 R) La présente partie de cette norme européenne spécifie les exigences relatives aux ventilateurs pulmonaires d'urgence et de transport, reliés a une source d'énergie. Elle couvre une gamme d'appareils allant des ventilateurs relativement simples, destinés essentiellement a etre utilisés avec un masque facial et pour des périodes limitées (par ex. avec des ventilateurs a énergie pneumatique) aux appareils prévus pour etre utilisés a plus long terme.

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

General Information

Status
Withdrawn
Publication Date
31-Dec-1999
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 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

Relations

Amended By
SIST EN 794-3:2000/A1:2005 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
22-Dec-2008
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
Amended By
SIST EN 794-3:2000/kprA2:2009 - Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
Effective Date
01-Apr-2009
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

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 794-3:2000
01-januar-2000
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 ventilat
...

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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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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.
NOTE 2 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
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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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FprEN ISO 80601-2-84

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;
–   intended to be operated by a healthcare professional operator;
–   intended for use in the EMS environment; and
–   intended for invasive or non-invasive ventilation.
NOTE 1 An EMS ventilator can also be used for transport within a professional healthcare facility.
* An EMS ventilator is not considered to utilize physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
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.
NOTE 2 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.
NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
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].
–   ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79[5] and ISO 80601-2-80[6] 1.
–   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].
–   NOTE 4 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
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