DIN EN 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
01-03-2013
12-01-2013
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
Annex ZA (normative) - Normative references to international
publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EC Directives
Bibliography
Index of defined terms
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