This specification presents particular requirements for an anesthesia workstation when supplied as a complete unit, as well as particular requirements for individual devices which together make up a complete anesthesia workstation. Both complete anesthesia workstation and the individual devices shall be commercially available to allow users to configure an anesthesia workstation to meet the needs of their clinical practice in conformance with their national regulations or guidelines, or both. To this end the standard has been structured in such a way as to clearly identify particular requirements pertinent to specific devices currently available. Referee test methods necessary to ensure compliance with the performance and safety requirements are described. While qualification test procedures to determine compliance are described and specified, equivalent or superior qualification test procedures to determine compliance with the requirements may be used.
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This clause of the GENERAL STANDARD applies with the following amendment:
1.5 This specification presents particular requirements for an ANESTHESIA WORKSTATION when supplied as a complete unit, as well as particular requirements for individual devices which together make up a complete ANESTHESIA WORKSTATION.
It is the intent of this specification that both complete ANESTHESIA WORKSTATIONS and the individual devices be commercially available to allow USERS to configure an ANESTHESIA WORKSTATION to meet the needs of their clinical practice in conformance with their national regulations or guidelines, or both. To this end the standard has been structured in such a way as to clearly identify particular requirements pertinent to specific devices currently available. Note 1
Although this specification does not mandate the use of a single communication protocol, the purpose of digital data communication in this specification is to facilitate transfer of data between devices. Possible uses of data from multiple sources include integrated data display and alarm annunciation, and aiding DECISION SUPPORT SYSTEMS. Centralized display integration and functional integration are the hallmarks differentiating this specification from previous anesthesia gas machine standards. Digital communication makes possible integration among workstation devices that may be modular, or interact only through communication interfaces. Documentation and disclosure requirements vary because of expected variations in implementation permitted by the specified standards. Additional documentation requirements are imposed when interface methods not included in the specified DIGITAL INTERFACE standards are encountered.
Equipment that can be used with flammable anesthetic agents, intermittent flow machines, that only deliver gas to the patient at varying rates in response to the patient's inspiratory efforts, and dental nitrous oxide - oxygen machines are not covered by this specification.
ICS Number Code 11.040.10 (Anaesthetic, respiratory and reanimation equipment)
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