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CSA Z21647 : 2007 : R2012 : FR

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
Available format(s)

Hardcopy , PDF

Superseded date

01-03-2014

Language(s)

English

Published date

01-01-2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and general requirements for tests
    4.101 Other test methods
    4.102 Acceptance criteria
5 Classification
6 Identification, marking and documents
    6.1 Marking on the outside of equipment or equipment parts
    6.3 Markings of controls and instruments
    6.8.2 Instructions for use
    6.101 Test for legibility
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
    10.1 Transport and storage
    10.2.2 Power supply
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
    21.101 Shock and vibration
    21.102 Shock and vibration for transport
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 radiat
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
    43.101 RGM used in conjunction with oxidants
44 Overflow, spillage, leakage, humidity, ingress of liquids,
    cleaning, sterilization, disinfection and compatibility
    44.3 Spillage
    44.7 Cleaning, sterilization and disinfection
    44.8 Compatibility with substances used with the equipment
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
    49.101 Power failure alarm conditions
    49.102 Settings and data storage following short
           interruptions or automatic switchover
    49.103 Reserve electrical power source
    49.104 Reserve electrical power source for use outside
           the healthcare facility
50 Accuracy of operating data
51 Protection against hazardous output
    51.101 Measurement accuracy
    51.102 Total system response time
    51.103 Indication of gas readings units of measure
    51.104 Indication of operating mode
52 Abnormal operation and fault conditions
53 Environmental tests
54 General
55 Enclosures and covers
56 Components and general assembly
    56.7 Batteries
57 Mains parts, components and layout
    57.3 Power supply cords
58 Protective earthing - terminals and connections
59 Construction and layout
101 Additional requirements specifically related to
    respiratory gas monitors
    101.1 Interfering gas and vapour effects
    101.2 Gas leakage
    101.3 Exhaust port connector for diverting respiratory
          gas monitor
    101.4 Minimum sampling flowrate
    101.5 Contamination of breathing systems
102 Alarm systems
    201.1.2 Alarm condition priority
    201.2 Disclosures for intelligent alarm system
    201.5 Alarm presets
    201.5.1 General requirements
    201.6.2 Adjustable alarm limit
    201.8 Alarm signal inactivation states
    201.8.3 Indication and access
103 Appendices of IEC 60601-1:1988
Annex A A - (informative) Rationale
Annex B B - (informative) Reference to the Essential
            Principles
Annex C C - (informative) Environmental aspects
Annex D D - (informative) Vocabulary - Index of defined
            terms
Bibliography

Specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) intended for continuous operation for use with humans.

DevelopmentNote
Supersedes CSA ISO 11196 & CSA ISO 7767. (01/2008) Supersedes CSA Z9918. (06/2008)
DocumentType
Standard
Pages
62
ProductNote
Reconfirmed F
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 21647:2004 Identical

ASTM F 1452 : 2001 Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors
IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 12598 : 1999 OXYGEN MONITORS FOR PATIENT BREATHING MIXTURES - PARTICULAR REQUIREMENTS
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 7767:1997 Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
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 9918:1993 Capnometers for use with humans Requirements
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
EN 864 : 1996 MEDICAL ELECTRICAL EQUIPMENT - CAPNOMETERS FOR USE WITH HUMANS - PARTICULAR REQUIREMENTS
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/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
IEC TR 60721-4-7:2001+AMD1:2003 CSV Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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