I.S. EN 794-1:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS
Hardcopy , PDF
05-05-2011
English
01-01-1997
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
Introduction
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
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 ultrasonics)
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 tests for Category AP equipment, parts and
components thereof
41 Requirements and tests 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 and compatibility
45 Pressure vessels and parts subject to pressure
46 Not used
47 Electrostatic charges
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 of visual
indications
Annex CC (informative) Typical ventilator arrangements
Annex DD (informative) Bibliography
Annex EE (informative) Auditory components of alarms
Annex FF (normative) Special national conditions
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC
Defines requirements for lung ventilators for medical use.
| DevelopmentNote |
1997 Edition Re-issued in June 2009 & incorporates AMD 2 2009. (06/2009)
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| Standards | Relationship |
| EN 794-1:1997+A2:2009 | Identical |
| DIN EN 794-1:2001-02 | Identical |
| UNE-EN 794-1:1997 | Identical |
| UNI EN 794-1 : 2009 | Identical |
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