BS 5724-2.202(1997) : 1997 + A2 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS
10-31-2006
11-23-2012
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
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
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.
Committee |
CH/121/5
|
DevelopmentNote |
Supersedes BS 5724-2.12(1990) Also numbered as BS EN 794-1 (06/2001) Supersedes 92/57252 DC and 00/561217 DC. (06/2005) 1997 Edition Re-Issued in May 2010 & incorporates AMD 2 2009. (05/2010)
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DocumentType |
Standard
|
PublisherName |
British Standards Institution
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Status |
Superseded
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SupersededBy | |
Supersedes |
Standards | Relationship |
EN 794-1:1997+A2:2009 | Identical |
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 |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
EN 475 : 1995 | MEDICAL DEVICES - ELECTRICALLY GENERATED ALARM SIGNALS |
ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
EN 1281-2 : 1995 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS |
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 |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
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 |
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 |
IEC 60801-2:1991 | Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements |
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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