ASTM_F_2761_-_09_2013.pdf

Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.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 F2761-09(2013)Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.Contents Page Foreword i Introduction iii 1.*Scope 1 2.Normative references 1 3.Terms and definitions 2 4.*ICE conceptual functional model 5 4.1 OVERVIEW 5 4.2 ICE NETWORK CONTROLLER 7 4.2.1*General 7 4.2.2 ICE NETWORK CONTROLLER INTERFACE 7 4.2.3*External interface 8 4.2.4*Forensic data logging 9 4.3 ICE SUPERVISOR 9 4.4*ICE EQUIPMENT INTERFACE 9 5.General requirements 9 5.1 RISK MANAGEMENT PROCESS 9 5.2.ICE EQUIPMENT INTERFACE QUALIFICATION TEST 10 5.3 Software 10 5.4 Communication management 10 5.5 ALARM SYSTEM 11 ANNEX A(INFORMATIVE)GUIDANCE AND RATIONALE 12 A.1 General Guidance 12 A.2 Rationale and guidance for particular clauses and subclauses 12 ANNEX B(INFORMATIVE)CLINICAL CONTEXT AND CLINICAL SCENARIOS 20 B.1 Purpose and introduction 20 B.2 Clinical Examples 21 ANNEX C(INFORMATIVE)REFERENCE TO THE ESSENTIAL PRINCIPALS 29 BIBLIOGRAPHY 31 TERMINOLOGY 34 F2761-09(2013)i Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.Foreword Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.ASTM shall not be held responsible for identifying any or all such patent rights.This ASTM standard was prepared by ASTM Committee F29,Anaesthetic and Respiratory Equipment,Subcommittee F29.21,Devices in the Integrated Clinical Environment.This work is based in part on concepts developed within the CIMIT Program 8 on Interoperability and the Massachusetts General Hospital program on Medical Device“Plug-and-Play”Interoperability(“MD PnP”program,founded 2004)with information disseminated through publications,workshops,and website.8,9,28,37 This is the first edition.F2761 is expected to be part of a series of standards,under the general title Medical Devices and Medical Systems Essential principles of safety and performance for equipment comprising the patient-centric integrated clinical environment(ICE):ASTM F2761,Medical Devices and Medical Systems Essential principles of safety and performance for equipment comprising the patient-centric integrated clinical environment(ICE)Part 1:General requirements and conceptual model(this standard)ASTM F,Medical Devices and Medical Systems Essential principles of safety and performance for equipment comprising the patient-centric integrated clinical environment(ICE)Part 2:Requirements for network control and equipment interface ASTM F,Medical Devices and Medical Systems Essential principles of safety and performance for equipment comprising the patient-centric integrated clinical environment(ICE)Part 3:Requirements for device models ASTM F,Medical Devices and Medical Systems Essential principles of safety and performance for equipment comprising the patient-centric integrated clinical environment(ICE)Part 4:Requirements for supervision ASTM F,Medical Devices and Medical Systems Essential principles of safety and performance for equipment comprising the patient-centric integrated clinical environment(ICE)Part 5:Requirements for safe and reliable integration In this standard,the following print types are used:Requirements and definitions:roman type.Test specifications:italic type.Informative material appearing outside of tables,such as notes,examples and references:in smaller type.Normative text of tables is also in a smaller type.TERMS DEFINED IN THIS STANDARD OR AS NOTED:SMALL CAPS.In this standard,the conjunctive“or”is used as an“inclusive or”so a statement is true if any combination of the conditions is true.F2761-09(2013)ii Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.For the purposes of this standard,the auxiliary verb:“shall”means that compliance with a requirement or a test is mandatory for compliance with this standard;“should”means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard;“may”is used to describe a permissible way to achieve compliance with a requirement or test.Clauses,subclauses,and definitions for which a rationale is provided in informative Annex A are marked with an asterisk(*).NOTE Attention is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new,amended or revised publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests.It is the recommendation of the committee that the content of this publication not be adopted for mandator