ASTM F2761 - 09(2013)

    Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

    Active Standard ASTM F2761 | Developed by Subcommittee: F29.21

    Book of Standards Volume: 13.02

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    1. Scope

    This standard specifies general requirements, a model and framework for integrating equipment to create a INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessary for the safe integration of MEDICAL DEVICES and other equipment, via an electronic interface, from different MANUFACTURERS into a single medical system for the care of a single high acuity PATIENT. This standard establishes requirements for a medical system that is intended to have greater error resistance and improved PATIENT safety, treatment efficacy and workflow efficiency than can be achieved with independently used MEDICAL DEVICES.

    This series of standards establishes requirements for design, verification, and validation processes of a modelbased integration system for an INTEGRATED CLINICAL ENVIRONMENT.

    This series of standards is intended to define the requirements essential for safety and thereby facilitate regulatory acceptance. NOTE These requirements were derived to support the clinical scenarios or clinical concepts of operations described in Annex B.

    ICS Code

    ICS Number Code 35.240.80 (IT applications in health care technology)

    UNSPSC Code

    UNSPSC Code 42000000(Medical Equipment and Accessories and Supplies)

    DOI: 10.1520/F2761

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    ASTM F2761

    Citing ASTM Standards
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