• There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

EN 794-2 : 1997

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE
Superseded date

24-03-2022

Published date

12-01-2013

Foreword
Introduction
Section one. General
1 Scope
2 Normative references
3 Terminology and definitions
4 General requirements and general requirements for test
5 Classification
6 Identification, marking and documents
7 Power input
Section two. Environment conditions
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
Section three. Protection against electric shock hazards
13 General
14 Requirements related to classification
15 Limitation of voltage and/or energy
16 Enclosures and protective covers
17 Separation
18 Protective earthing, functional earthing and
    potential equalization
19 Continuous leakage currents and patient auxiliary
    currents
20 Dielectric strength
Section four. Protection against mechanical hazards
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
Section five. Protection against hazards from unwanted or
excessive radiation
29 X-radiation
30 Alpha, beta, gamma, neutron radiation and other
    particle radiation
31 Microwave radiation
32 Light radiation (including lasers)
33 Infra-red radiation
34 Ultra-violet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
Section six. Protection against hazards of ignition of
flammable anaesthetic mixtures
37 Locations and basic requirements
38 Marking and accompanying documents
39 Common requirements for Category AP and Category AGP
    equipment
40 Requirements and tests for Category AP equipment,
    parts and components thereof
41 Requirements and tests for category APG equipment,
    parts and components thereof
Section seven. Protection against excessive temperature
and other safety hazards
42 Excessive temperatures
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of
    liquids, cleaning, sterilization, disinfection and
    compatibility
45 Pressure vessels and parts subject to pressure
46 Not used
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
Section eight. Accuracy of operating data and protection
against hazardous output
50 Accuracy of operating data
51 Protection against hazardous output
Section nine. Abnormal operation and fault conditions:
environmental tests
52 Abnormal operation and fault conditions
53 Environmental tests
Section ten. Constructional requirements
54 General
55 Enclosures and covers
56 Components and general assembly
57 Mains parts, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
Annex AA (informative) Rationale
Annex BB (normative) Legibility and visibility of visual
indication
Annex CC (informative) Typical ventilator arrangements
Annex DD (informative) Special national conditions
Annex EE (normative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other Provisions of
EU Directives

Defines requirements for lung ventilators largely for home care use for patients, but in certain circumstances could be used in hospital. ALSO NUMBERED AS BS 5724-2.203(1997)

Committee
TC 215
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
BS 5724-2.203(1997) : 1997 Identical
NS EN 794-2 : 1ED 1997 Identical
SN EN 794-2 : 1998 Identical
DIN EN 794-2:1997-09 Identical
I.S. EN 794-2:1997 Identical
UNI EN 794-2 : 2000 Identical
UNE-EN 794-2:1997 Identical
NEN EN 794-2 : 1997 Identical
BS EN 794-2:1997 Identical
NF EN 794-2 : 1997 Identical
NBN EN 794-2 : 1997 Identical

I.S. EN 794-3:1998 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
UNI EN 794-3 : 2009 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
BS EN 794-3 : 1999 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
DIN EN 794-3:2009-12 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators (includes Amendment A2:2009)
UNE-EN 794-3:1999 LUNG VENTILATORS. PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS.

EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN 738-1:1997/A1:2002 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES
EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
EN 1281-2 : 1995 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS
ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
ISO 9360:1992 Anaesthetic and respiratory equipment — Heat and moisture exchangers for use in humidifying respired gases in humans
EN 1281-1:1997/A1:1998 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 980:2008 Symbols for use in the labelling of medical devices
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
EN 60801-2 : 1993 ELECTROMAGNETIC COMPATIBILITY FOR INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL EQUIPMENT - PART 2: ELECTROSTATIC DISCHARGE REQUIREMENTS (IEC 801-2:1991)

View more information
Sorry this product is not available in your region.

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.