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CSA C22.2 No. 60601.2.13 :2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF ANAESTHETIC SYSTEMS
Available format(s)

Hardcopy , PDF

Superseded date

12-13-2015

Language(s)

English

Published date

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
CSA C22.2 No. 60601.1.2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS

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