EN ISO 80601-2-13:2012

Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT
        and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
        HAZARDS
201.11 Protection against excessive temperatures and other
        HAZARDS
201.12 Accuracy of controls and instruments and protection
        against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT AND ME
        SYSTEMS
201.101 Additional requirements for ANAESTHETIC GAS DELIVERY
        SYSTEMS
201.102 Additional requirements for an ANAESTHETIC BREATHING
        SYSTEM
201.103 Additional requirements for an ANAESTHETIC GAS
        SCAVENGING SYSTEM
201.104 Additional requirements for an ANAESTHETIC VAPOUR
        DELIVERY SYSTEM
201.105 Additional requirements for an ANAESTHETIC VENTILATOR
        pause
201.106 Display loops
201.107 Clinical evaluation
202 Electromagnetic compatibility - Requirements and tests
203 General requirements for radiation protection in
        diagnostic X-ray equipment
206 Usability
208 General requirements, tests and guidance for ALARM
        SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
        ELECTRICAL SYSTEMS
209 Requirements for environmentally conscious design
210 PROCESS requirements for the development of physiologic
        closed-loop controllers
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
        ELECTRICAL SYSTEMS used in the home healthcare
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS or their
        parts
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (normative) - Test for flammability of anaesthetic
         agent
Annex CC (informative) - Environmental aspects
Annex DD (informative) - Reference to the essential principles
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
Bibliography
Alphabetized index of defined terms used in this particular
standard

ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: anaesthetic gas delivery system; anaesthetic breathing system; anaesthetic gas scavenging system; anaesthetic vapour delivery system; anaesthetic ventilator; monitoring equipment; alarm system; protection device.ISO/IEC 80601-2-13:2011 is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components, as relevant.Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of ISO/IEC 80601-2-13:2011 are not covered by specific requirements in ISO/IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.ISO/IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.