EN 794-2 : 1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE
03-24-2022
01-12-2013
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; German version EN 794-3:1998+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) |
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