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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, 2019
- 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
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Committee representation
- Foreword
- Introduction
- 1. *Scope
- Normative references
- 3 Terms and definitions
- 4 *ICE conceptual functional model [Go to Page]
- 4.1 Overview [Go to Page]
- Figure 1 — Conceptual functional model showing the elements of the INTEGRATED CLINICAL ENVIRONMENT
- 4.2 ICE NETWORK CONTROLLER [Go to Page]
- 4.2.1 * General
- 4.2.2 ICE NETWORK CONTROLLER interface
- 4.2.3 * External interface
- 4.2.4 * Forensic data logging
- 4.3 *ICE SUPERVISOR
- 4.4 * ICE EQUIPMENT INTERFACE
- 5 General requirements [Go to Page]
- 5.1 RISK MANAGEMENT PROCESS
- 5.2 * ICE EQUIPMENT INTERFACE qualification test
- 5.3 Software
- 5.4 Communication management
- 5.5 ALARM SYSTEM
- Annex A (informative)
Guidance and rationale [Go to Page]
- A.1 General guidance
- A.2 Rationale and guidance for particular clauses and subclauses [Go to Page]
- Clause 1 Scope
- Definition 3.3 DEVICE MODEL
- Definition 3.6 INTEGRATED CLINICAL ENVIRONMENT (ICE)
- Subclause 4.2 ICE NETWORK CONTROLLER
- Subclause 4.2.1 General
- Subclause 4.2.3 External interface
- Subclause 4.2.4 Forensic data logging
- Subclause 4.4 ICE EQUIPMENT INTERFACE
- Annex B (informative)
Clinical context and clinical scenarios [Go to Page]
- B.1 Purpose and introduction [Go to Page]
- B.1.1 Purpose
- B.1.2 Methodology
- B.1.3 Clinical scenario
- B.1.4 Clinical concept of operations (CConOps)
- B.2 Clinical Examples [Go to Page]
- B.2.1 Safety Interlocks [Go to Page]
- B.2.1.1 Clinical scenario, safety Interlock
- B.2.1.2 CConOps, safety Interlock
- B.2.2 Synchronization with safety interlock [Go to Page]
- B.2.2.1 Clinical scenario, synchronization with safety interlock
- B.2.2.2 CConOps, synchronization with safety interlock
- B.2.3 Process control (workflow) [Go to Page]
- B.2.3.1 Clinical scenario, process control
- B.2.3.2 CConOps, process control
- B.2.4 Smart alarm system [Go to Page]
- B.2.4.1 Clinical scenario, smart alarm system
- B.2.4.2 CConOps, smart alarm system
- B.2.5 Decision support [Go to Page]
- B.2.5.1 Clinical Scenario, decision support
- B.2.5.2 CConOps, decision support
- B.2.6 Physiological Closed Loop Control (PCLC) [Go to Page]
- B.2.6.1 Clinical scenario, PCLC
- B.2.6.2 CConOps, PCLC
- B.2.7 Medical Device Plug-and-Play Interoperability (MD PnP) [Go to Page]
- B.2.7.1 Clinical scenario, MD PnP
- B.2.7.2 CConOps, MD PnP
- Annex C (informative)
Reference to the Essential Principals [Go to Page]
- Table C.1 — Correspondence between the Essential Principles and this standard
- Bibliography
- Terminology – Alphabetized index of defined terms [Go to Page]
