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BS EN ISO 8835-5:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Inhalational anaesthesia systems Anaesthesia ventilators
Available format(s)

Hardcopy , PDF

Superseded date

28-02-2013

Language(s)

English

Published date

31-07-2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms 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
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 Ultraviolet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
37 Locations and basic requirements
38 Marking and 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 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of
    liquids, cleaning, sterilization, disinfection and
    compatibility
45 Pressure vessels and parts subject to pressure
46 Human errors
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
101 Additional requirements for anaesthetic ventilators
102 Appendices of IEC 60601-1:1988
Annex AA (informative) - Rationale
Annex BB (normative) - Test for flammability of anaesthetic
         agents
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

Describes particular requirements for the essential performance of anaesthetic ventilators.

Committee
CH/121/1
DevelopmentNote
Supersedes 01/561641 DC. To be read in conjunction with BS EN 60601-1. (08/2004) Together with BS EN 60601-2-13, BS EN ISO 8835-2 and BS EN ISO 8835-4 supersedes BS EN 740 and BS 5724-2.204(1999). (12/2007)
DocumentType
Standard
Pages
34
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
ISO 5145:2014 Cylinder valve outlets for gases and gas mixtures Selection and dimensioning
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
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
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
IEC 60079-11:2011 Explosive atmospheres - Part 11: Equipment protection by intrinsic safety "i"
IEC 60601-2-13:2003+AMD1:2006 CSV Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
ISO 10524:1995 Pressure regulators and pressure regulators with flow-metering devices for medical gas systems
NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
ISO 5358:1992 Anaesthetic machines for use with humans
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 8835-2:2007 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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Including GST where applicable

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