ASTM-F1850:2005 Edition

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F1850-00(2005) Standard Specification for Particular Requirements for Anesthesia Workstations and Their Components

Published By	Publication Date	Number of Pages
ASTM	2005	32

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Categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment, ASTM

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Description

ASTM F1850-00-Reapproved2005

Withdrawn Standard: Standard Specification for Particular Requirements for Anesthesia Workstations and Their Components (Withdrawn 2014)

ASTM F1850

Scope

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.

Keywords

ICS Code

ICS Number Code 11.040.10 (Anaesthetic, respiratory and reanimation equipment)

DOI: 10.1520/F1850-00R05

PDF Catalog

PDF Pages	PDF Title
1	Scope
3	Terminology
4	General Requirements
5	General Requirements for Tests Classification Identification, Marking and Documents
7	Power Input Basic Safety Categories Removable Protective Means Environmental Conditions (Previous Title): Special Measures with Respect to Safety (Previous Title): Single Fault Condition
8	General Requirements Related to Classification Limitation of Voltage and/or Energy ENCLOSURES and PROTECTIVE COVERS Separation (Previous Title: Insulation and Protective Impedances) Protective Earthing, Functional Earthing and Potential Equalization Continuous Leakage Current and Patient Auxiliary Current Dielectric Strength Mechanical Strength Moving Parts Surfaces, Corners, and Edges Stability in NORMAL USE Expelled Parts Vibration and Noise Pneumatic and Hydraulic Power Suspended Masses X-Radiation Alpha, Beta, Gamma, Neutron Radiation and Other Particle Radiation Microwave Radiation Light Radiation (Including Lasers) Infra-Red Radiation Ultra-Violet Radiation Acoustical Energy (Including Ultrasonics) Electromagnetic Compatibility Locations and Basic Requirements
9	Marking and Accompanying Documents Common Requirements for CATEGORY AP and CATEGORY EQUIPMENT Requirements and Tests for CATEGORY AP EQUIPMENT, Parts and Components Thereof Requirements and Test for CATEGORY APG EQUIPMENT, Parts and Components Thereof Excessive Temperatures Fire Prevention Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection Pressure Vessels and Parts Subject to PRESSURE Human Errors Electrostatic Charges Materials in APPLIED PARTS in Contact with the Body of the Patient Interruption of the Power Supply
10	Accuracy of Operating Data Protection Against Hazardous Output
13	Abnormal Operation and Fault Conditions Environmental Tests General Enclosures and Covers Components and General Assembly Mains Parts, Components and Layout Protective Earthing—Terminals and Connections
14	Construction and Layout Medical Gas Cylinder Attachments Medical Gas Supply Pressure Indicator(s) Gas Pressure Reducing Device/System
15	Anesthesia Gas Supply Piping
16	Flow Adjustment Control(s) Flow Indicators
17	Gas Mixing System Oxygen Flush Anesthetic Vapor Delivery Device(s)
18	Common Gas Outlet
19	Pipeline Inlet Connections Gas Power Outlet(s) Checklist Breathing Systems Anesthetic Gas Scavenging Systems Suction Equipment Auxiliary Oxygen Flowmeter Other Auxiliary Equipment Data Interfaces
22	A1. REFERENCES A1.1 AAMI Documents A1.2 ASME Standard11 A1.3 ASTM Standards12 A1.4 CGA Standards5 A1.5 EIA/TIA Documents3 A1.6 HL7 Document10 A1.7 IEC Standards2 A1.8 IEEE Standards4 A1.9 ISO Standards2
23	A2. METHOD OF TEST FOR THE ACCURACY OF DELIVERED VAPOR CONCENTRATION DURING OXYGEN FLUSH A2.1 A2.2 A2.3 A2.4 A2.5 A2.6 X1. COMMUNICATION INTERFACE: DOCUMENTATION AND SUPPORT X1.1
24	X2. COMMUNICATION INTERFACE: CONTROL OF ALARMS X2.1 X2.2 X2.3 X2.4 X2.5 X2.6 X3. RATIONALE X3.1 X3.2 X3.3 X3.4 X3.5 X3.6 X3.7 X3.8 X3.9 X3.10
25	X3.11 X3.12
26	X3.13 X3.14 X3.15 X3.16 X3.17 X3.18 X3.19 X3.20 X3.21 X3.22 Clause 78—Communication Interface: Rationale
29	TABLE 1 TABLE 2
30	TABLE 3 TABLE 4 TABLE 5 TABLE 6 TABLE 7
31	FIG. 1 FIG. 2
32	FIG. 3

Additional information

Standard Title	F1850-00(2005) Standard Specification for Particular Requirements for Anesthesia Workstations and Their Components
Published Code	ASTM
Publication Date	2005
Pages Count	32
ICS Codes	11.040.10 - Anaesthetic, respiratory and reanimation equipment