This standard specifies general requirements, a model, and framework for integrating equipment to create an 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 model-based 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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI 2700-1:2019; Medical Devices and Medical Systems\u2014Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)\u2014Part 1: General requirements and conceptual model <\/td>\n<\/tr>\n | ||||||
| 2<\/td>\n | Objectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1. *Scope Normative references <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4 *ICE conceptual functional model 4.1 Overview <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | Figure 1 \u2014 Conceptual functional model showing the elements of the INTEGRATED CLINICAL ENVIRONMENT <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4.2 ICE NETWORK CONTROLLER 4.2.1 * General <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 4.2.2 ICE NETWORK CONTROLLER interface 4.2.3 * External interface <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.2.4 * Forensic data logging 4.3 *ICE SUPERVISOR 4.4 * ICE EQUIPMENT INTERFACE 5 General requirements 5.1 RISK MANAGEMENT PROCESS <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.2 * ICE EQUIPMENT INTERFACE qualification test 5.3 Software 5.4 Communication management <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.5 ALARM SYSTEM <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Annex A (informative) \nGuidance and rationale A.1 General guidance A.2 Rationale and guidance for particular clauses and subclauses Clause 1 Scope <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Definition 3.3 DEVICE MODEL <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | Definition 3.6 INTEGRATED CLINICAL ENVIRONMENT (ICE) <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Subclause 4.2 ICE NETWORK CONTROLLER <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Subclause 4.2.1 General Subclause 4.2.3 External interface <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Subclause 4.2.4 Forensic data logging <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Subclause 4.4 ICE EQUIPMENT INTERFACE <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | Annex B (informative) \nClinical context and clinical scenarios B.1 Purpose and introduction B.1.1 Purpose B.1.2 Methodology <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | B.1.3 Clinical scenario B.1.4 Clinical concept of operations (CConOps) B.2 Clinical Examples B.2.1 Safety Interlocks B.2.1.1 Clinical scenario, safety Interlock <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | B.2.1.2 CConOps, safety Interlock <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | B.2.2 Synchronization with safety interlock B.2.2.1 Clinical scenario, synchronization with safety interlock B.2.2.2 CConOps, synchronization with safety interlock <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | B.2.3 Process control (workflow) B.2.3.1 Clinical scenario, process control B.2.3.2 CConOps, process control B.2.4 Smart alarm system B.2.4.1 Clinical scenario, smart alarm system <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | B.2.4.2 CConOps, smart alarm system B.2.5 Decision support B.2.5.1 Clinical Scenario, decision support <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | B.2.5.2 CConOps, decision support B.2.6 Physiological Closed Loop Control (PCLC) B.2.6.1 Clinical scenario, PCLC B.2.6.2 CConOps, PCLC <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | B.2.7 Medical Device Plug-and-Play Interoperability (MD PnP) B.2.7.1 Clinical scenario, MD PnP B.2.7.2 CConOps, MD PnP <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Annex C (informative) \nReference to the Essential Principals Table C.1 \u2014 Correspondence between the Essential Principles and this standard <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | Terminology \u2013 Alphabetized index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI 2700-1:2019 – Medical Devices and Medical Systems-Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)-Part 1: General requirements and conceptual model<\/b><\/p>\n |