標準號：ASTM F1850-2000
中文標準名稱：麻醉操作工位及其部件的特殊要求的標準規范
英文標準名稱：Standard Specification for Particular Requirements for Anesthesia Workstations and Their Components
標準類型：C31
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C31
國際標準分類號：11.040.10 (Anaesthetic, respiratory and reanimatio
適用范圍：This clause of the GENERAL STANDARD applies with the following amendment: 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. 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.