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CSA C22.2 No. 60601.2.12 : 2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
Available format(s)

Hardcopy , PDF

Superseded date

01-11-2012

Language(s)

English

Published date

01-01-2003

Foreword
Introduction
Section One - General
1 Scope And Object
2 Terminology And Definitions
3 General Requirements
4 General Requirements For Tests
5 Classification
6 Identification, Marking And Documents
7 Power Input
Section Two - Environmental Conditions
8 Basic Safety Requirements
9 Removable Protective Means
10 Environmental Conditions
Section Three - Protection Against Electric Shock
                Hazards
13 General
14 Requirements Related To Classification
15 Limitation Of Voltage And/Or Energy
16 Enclosures And Protective Covers
17 Insulation And Protective Impedances
18 Earthing And Potential Equalization
19 Continuous Leakage Currents And Patient Auxiliary
   Currents
20 Dielectric Strength
Section Four - Protection Against Mechanical Hazards
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
Section Five - Protection Against Hazards From Unwanted
               Or Excessive Radiation
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 Ultrasonic)
36 Electromagnetic Compatibility
Section Six - Protection Against Hazards Of Ignition
              Of Flammable Anesthetic Mixtures
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
Section Seven - Protection Against Excessive Temperatures
                And Other Safety Hazards
42 Excessive Temperatures
43 Fire Prevention
44 Overflow, Spillage, Leakage, Humidity, Ingress Of
   Liquids, Cleaning, Sterilization And Disinfection
45 Pressure Vessels And Parts Subject To Pressure
46 Human Errors
47 Electrostatic Charges
48 Biocompatibility
49 Interruption Of The Power Supply
Section Eight - Accuracy Of Operating Data And
                Protection Against Hazardous Output
50 Accuracy Of Operating Data
51 Protection Against Hazardous Output
Section Nine - Abnormal Operation And Fault Conditions;
               Environmental Tests
52 Abnormal Operation And Fault Conditions
53 Environmental Tests
Section Ten - Constructional Requirements
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
Appendix L - References - Publications mentioned in this
             standard
Annex AA (informative) - Rationale
Annex BB (normative) - Legibility and visibility of visual
                         indications
Annex CC (informative) - Intelligent alarm systems
Bibliography
Terminology - Index of defined terms

Specifies safety requirements for lung ventilators that incorporate electrical devices, where the equipment is designed for medical use.

DocumentType
Standard
Pages
52
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy

Standards Relationship
IEC 60601-2-12:2001 Identical

CSA Z8185 : 2008 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
CSA Z8185 : 2008(R2013) RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS

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
IEC 60416:1988 General principles for the formulation of graphical symbols
ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
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 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10651-3:1997 Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
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
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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