UNI EN 794-3 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
24-01-2024
28-10-2009
Foreword
Introduction
Section one. General
1 Scope
2 Normative references
3 Terminology and definitions
4 General requirements and general requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
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
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
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 ultra-sonics)
36 Electromagnetic compatibility
37 Locations and basic requirements
38 Marking, accompanying documents
39 Common requirements for Category AP and Category
APG equipment
40 Requirements and test for Category AP equipment, parts
and components thereof
41 Requirements and test for Category APG equipment, parts
and components thereof
42 Excessive temperatures
43 R) Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids,
cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to pressure
46 Not used
47 Not used
48 Biocompatibility
49 Interruption of the power supply
50 Accuracy of operating data
51 Protection against hazardous output
52 Abnormal operation and fault conditions
53 Environmental tests
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
Annex CC (informative) - Bibliography
Annex DD (normative) - Special national conditions
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Describes requirements for ventilators, driven by a power source and intended for emergency and transport use. Deals with 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. Also covers gas-powered resuscitators, which are generally used by first responders.
Committee |
CT 44
|
DocumentType |
Standard
|
PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
NF EN 794-3 : 1998 + A2 2009 | Identical |
NS EN 794-3 : 1998 + A2 2009 | Identical |
UNE-EN 794-3:1999 | Identical |
I.S. EN 794-3:1998 | Identical |
BS EN 794-3 : 1999 | Identical |
SN EN 794-3 : 1999 + A2 2010 | Identical |
EN 794-3:1998+A2:2009 | Identical |
DIN EN 794-3:2009-12 | Identical |
NEN EN 794-3 : 1998 + A2 2009 | Identical |
NBN EN 794-3 : 1998 + A2 2009 | Identical |
ONORM EN 794-3 : 2010 | Identical |
EN 794-1:1997+A2:2009 | Lung ventilators - Part 1: Particular requirements for critical care ventilators |
EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
EN 12342:1998+A1:2009 | Breathing tubes intended for use with anaesthetic apparatus and ventilators |
EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
EN 794-2 : 1997 | LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE |
EN 738-1:1997/A1:2002 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES |
EN 865 : 1997 | PULSE OXIMETERS - PARTICULAR REQUIREMENTS |
EN 475 : 1995 | MEDICAL DEVICES - ELECTRICALLY GENERATED ALARM SIGNALS |
EN 1820:2005+A1:2009 | Anaesthetic reservoir bags (ISO 5362:2000, modified) |
EN 737-1 : 1998 | MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM |
EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
EN 1281-2 : 1995 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS |
EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
ISO 32:1977 | Gas cylinders for medical use — Marking for identification of content |
EN 864 : 1996 | MEDICAL ELECTRICAL EQUIPMENT - CAPNOMETERS FOR USE WITH HUMANS - PARTICULAR REQUIREMENTS |
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 |
ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
EN 739:1998/A1:2002 | LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
NFPA 53M : 1990 | FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES |
IEC 60068-2-29:1987 | Environmental testing. Part 2: Tests. Test Eb and guidance: Bump |
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 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
EN ISO 4135:2001 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
EN ISO 8185:2009 | Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
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 |
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.