CSA C22.2 No. 60601.1.1 : 2002
Withdrawn
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
01-01-2002
08-26-2016
FOREWORD
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
16 ENCLOSURES and PROTECTIVE COVERS
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
22 Moving parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids,
cleaning, sterilization, disinfection and compatibility
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
Annex AAA (informative) - General guidance and rationale
Annex BBB (informative) - Examples of combinations of MEDICAL
ELECTRICAL EQUIPMENT and non-medical electrical
equipment
Annex CCC (normative) - Normative references
Annex DDD (informative) - Bibliography
Annex EEE (normative) - Requirements for MULTIPLE PORTABLE
SOCKET-OUTLETS
Annex FFF (informative) - Examples of application of MULTIPLE
PORTABLE SOCKET-OUTLETS
Pertains to the safety of MEDICAL ELECTRICAL SYSTEMS. Describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.
| DevelopmentNote |
Supersedes CSA C22.2.601.1.1. (02/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Standards | Relationship |
| IEC 60601-1-1:2000 | Identical |
| CSA Z17510.2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| IEC 60950:1999 | Safety of information technology equipment |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60884-1:2002+AMD1:2006+AMD2:2013 CSV | Plugs and socket-outlets for household and similar purposes - Part1: General requirements |
| ISO 8359:1996 | Oxygen concentrators for medical use — Safety requirements |
| ISO 7767:1997 | Oxygen monitors for monitoring patient breathing mixtures — Safety requirements |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| ISO 9918:1993 | Capnometers for use with humans — Requirements |
| ISO 10079-1:2015 | Medical suction equipment — Part 1: Electrically powered suction equipment |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| IEC 60989:1991 | Separating transformers, autotransformers, variable transformersand reactors. |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - 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 |