ASTM F2761 - 09(2013) - Medical Devices and Medical Systems. Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE). General requirements and conceptual model

ASTM F2761 - 09(2013)

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

Status : Current   Published : January 2009

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PDF

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HARDCOPY



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.




Standard NumberASTM F2761 - 09(2013)
TitleMedical Devices and Medical Systems. Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE). General requirements and conceptual model
StatusCurrent
Publication Date03 January 2009
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Biomedical Engineering, Health Care Facilities, Integrated Clinical Environment, Medical Devices
ICS35.240.80
PublisherASTM
FormatA4
DeliveryYes
Pages39
File Size216 KB
Price£58.00


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