CSA C22.2 No. 60601.2.12 : 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
Hardcopy , PDF
01-11-2012
English
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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