ASTM F2761-09 (2013)

Standard Organization:

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

Recognition Date	2014-07-09
Recognition List	036
Recognition Number	13-46
Extent	Complete standard
Standards Orgs	ASTM ASTM International http://www.astm.org/
STG	Software/Informatics
FDA Tech	Sandy Weininger FDA/OMPT/CDRH/OSEL/DBP/ 301-796-2582 sandy.weininger@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

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.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§870.2300	System, Network And Communication, Physiological Monitors	Class 2	MSX

FDA Guidance:

Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005