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CSA ISO 11196 : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ANAESTHETIC GAS MONITORS
Available format(s)

Hardcopy , PDF

Superseded date

09-01-2007

Language(s)

English

Section 1 General
1.1 Scope
1.2 Normative references
1.3 Definitions
1.4 General requirements and general requirements for
     tests
1.5 Classification
1.6 Identification, marking and documents
1.7 Power input
Section 2 Environmental conditions
2.1 Basic safety categories
2.2 Removable protective means
2.3 Environmental conditions
Section 3 Protection against electric shock hazards
3.1 General
3.2 Requirements related to classification
3.3 Limitation of voltage and/or energy
3.4 Enclosures and protective covers
3.5 Separation
3.6 Protective earthing, functional earthing and
     potential equalization
3.7 Continuous leakage current and patient auxiliary
     currents
3.8 Dielectric strength
Section 4 Protection against mechanical hazards
4.1 Mechanical strength
4.2 Moving parts
4.3 Surface, corners and edges
4.4 Stability in normal use
4.5 Expelled parts
4.6 Vibration and noise
4.7 Pneumatic and hydraulic power
4.8 Suspended masses
Section 5 Protection against hazards from unwanted or
          excessive radiation
5.1 X-radiation
5.2 Alpha, beta, gamma, neutron radiation and other
     particle radiation
5.3 Microwave radiation
5.4 Light radiation (including lasers)
5.5 Infrared radiation
5.6 Ultraviolet radiation
5.7 Acoustical energy (including ultrasonics)
5.8 Electromagnetic compatibility
Section 6 Protection against hazards of ignition of
          flammable anaesthetic mixtures
6.1 Locations and basic requirements
6.2 Marking, accompanying documents
6.3 Common requirements for categories AP and APG
     equipment
6.4 Requirements and tests for category AP equipment,
     parts and components
6.5 Requirements and tests for category APG equipment,
     parts and components
Section 7 Protection against excessive temperatures
          and other safety hazards
7.1 Excessive temperatures
7.2 Fire prevention
7.3 Overflow, spillage, leakage, humidity, ingress of
     liquids, cleaning, sterilization and disinfection
7.4 Pressure vessels and parts subject to pressure
7.5 Human errors
7.6 Electrostatic charges
7.7 Materials in applied parts in contact with body of
     patient
7.8 Interruption of power supply
Section 8 Accuracy of operating data and protection
          against hazardous output
8.1 Accuracy of operating data
8.2 Protection against hazardous output
Section 9 Abnormal operation and fault conditions,
          environment tests
9.1 Abnormal operation and fault conditions
9.2 Environmental tests
Section 10 Constructional requirements
10.1 General
10.2 Enclosures and covers
10.3 Components and general assembly
10.4 Main parts, components and layout
10.5 Protective earthing - Terminals and connections
10.6 Construction and layout
Section 11 Additional requirements specific to
           anaesthetic gas monitors
11.1 Interfering gas and vapour effects (other than
     water vapour)
11.2 Obstruction of sampling tube
11.3 Breathing system connections
11.4 Contamination of breathing systems
Annexes
A to L
M Test of anaesthetic agents for non-flammability
N Rationale
P Bibliography

Defines requirements for anaesthetic gas monitors intended for use in determining the anaesthetic vapour and/or gas level(s) in breathing gas mixtures and/or fresh gas mixtures. Both diverting and non-diverting anaesthetic gas monitors are covered, irrespective of the measuring technology used.

DocumentType
Standard
Pages
46
PublisherName
Canadian Standards Association
Status
Superseded

CSA C22.2 No. 601.2.13 : 0 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC MACHINES

ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
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
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
IEC 60079-3:1990 Electrical apparatus for explosive gas atmospheres - Part 3: Spark-test apparatus for intrinsically-safe circuits
ISO 6142:2001 Gas analysis Preparation of calibration gas mixtures Gravimetric method
NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
ISO 7504:2015 Gas analysis Vocabulary
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
IEC 60801-2:1991 Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements

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