CSA C22.2 No. 60601.2.13 :2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
Hardcopy , PDF
13-12-2015
English
01-01-2012
FOREWORD
INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
HAZARDS
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
49 Interruption of the POWER SUPPLY
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
56 Components and general assembly
57 MAINS PARTS, components and layout
SECTION 101 - ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC
GAS DELIVERY SYSTEMS
101 Medical gas supply
102 Medical gas pipeline inlet connections
103 Medical gas supply pressure monitoring
104 Medical gas supply PRESSURE REGULATORS
105 Anaesthetic gas delivery system piping
106 Gas flow metering
107 Gas mixer
108 Oxygen flush
109 Fresh gas outlet
110 Checklist
Annex AA (informative) Guidance and rationale for particular
clauses and subclauses in this particular standard
Annex BB (informative) MONITORING DEVICES, ALARM SYSTEM(S)
and PROTECTION DEVICES
Annex CC (informative) Separate devices of an ANAESTHETIC
SYSTEM
Annex DD (normative) Test for flammability of anaesthetic
agent
Annex EE (informative) Clauses of this International Standard
addressing the essential requirements or other
provisions of EU directives
Bibliography
Index of defined terms
Specifies safety and essential performance requirements for an ANAESTHETIC SYSTEM as well as individual devices designed for use in an ANAESTHETIC SYSTEM.
| DevelopmentNote |
Supersedes CSA C22.2.601.2.13. (02/2006)
|
| DocumentType |
Standard
|
| Pages |
74
|
| ProductNote |
Reconfirmed EN
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-2-13:2003+AMD1:2006 CSV | Identical |
| CGA V 1 : 2013 | STANDARD FOR COMPRESSED GAS CYLINDER VALVE OUTLET AND INLET CONNECTIONS |
| CSA ISO 9703-1 : 0 | ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 1: VISUAL ALARM SIGNALS |
| CSA Z8835.5 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
| CSA Z8835.3 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
| CSA C22.2 No. 60601.1.1 : 2002 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| CSA Z8835.2 : 2008 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS |
| NFPA 53 : 2016 | MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
| CSA Z8835.4 : 2006 | INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
| ISO 21647:2004 | Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| CSA C22.2 No. 601.1S1 : 1994 | SUPPLEMENT NO 1-94 TO CAN/CSA-C22.2 NO. 601.1-M90 - MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY |
| CSA C22.2 No. 601.1B : 1998(R2006) | AMENDMENT 2 TO CAN/CSA-C22.2 NO. 601.1-M90, MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY |
| CSA Z10524 : 2002 | PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES FOR MEDICAL GAS SYSTEMS |
| CSA ISO 9703-2 : 0 | ANAESTHESIA AND RESPIRATORY CARE ALARM SIGNALS - PART 2: AUDITORY ALARM SIGNALS |
| CGA V 5 : 2008(R2013) | DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS) |
| CSA Z5359 : 2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
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