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AAMI/IEC TIR80001-2-1:2012 - Application of risk management for IT-networks incorporating medical device-Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples, 2012
- ANSI/AAMI/IEC TIR80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples
- Title page
- Copyright information
- AAMI Technical Information Report
- ANSI Technical Report
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI adoption of IEC/TR 80001-2-1:2012
- FOREWORD
- INTRODUCTION
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Prerequisites
- 5 Study of terms used in risk management [Go to Page]
- 5.1 Overview
- 5.2 Hazards
- 5.3 Hazardous situations
- 5.4 Foreseeable sequences of events and causes
- 5.5 Unintended consequence
- 5.6 Risk control measures (mitigations)
- 5.7 Degrees of risk
- 5.8 Checking wording
- 6 The steps [Go to Page]
- 6.1 Overview of the steps
- 6.2 A basic example using the 10 steps [Go to Page]
- 6.2.1 General
- 6.2.2 Initial risk – Steps 1 – 5 (Figure 2)
- 6.2.3 Risk control and final risk – Steps 6 – 10 (Figure 3)
- 7 IEC 80001-1:2010, Subclause 4.4: Step by step [Go to Page]
- 7.1 General
- 7.2 Application of Subclause 4.4.1: Document all risk management elements
- 7.3 Note about risk evaluation
- 7.4 The 10-step process [Go to Page]
- 7.4.1 STEP 1: Identify hazards and hazardous situations
- 7.4.2 STEP 2: Identify causes and resulting hazardous situations [Go to Page]
- 7.4.2.1 General
- 7.4.2.2 Multiple causes per hazardous situation
- 7.4.2.3 Multiple hazardous situations per cause
- 7.4.3 STEP 3: Determine unintended consequences and estimate the potential severities
- 7.4.4 STEP 4: Estimate the probability of unintended consequence [Go to Page]
- 7.4.4.1 General
- 7.4.4.2 Probability estimations
- 7.4.5 STEP 5: Evaluate risk
- 7.4.6 STEP 6: Identify and document proposed risk control measures and re-evaluate risk (return to Step 3) [Go to Page]
- 7.4.6.1 General
- 7.4.6.2 Identify risk control measures
- 7.4.6.3 Select risk control measure
- 7.4.6.4 Re-evaluate risk
- 7.4.6.5 Risk/benefit analysis
- 7.4.7 STEP 7: Implement risk control measures
- 7.4.8 STEP 8: Verify risk control measures [Go to Page]
- 7.4.8.1 General
- 7.4.8.2 Verification of effectiveness
- 7.4.8.3 Verification of implementation
- 7.4.9 STEP 9: Evaluate any new risks arising from risk control
- 7.4.10 STEP 10: Evaluate and report overall residual risk
- 7.5 The steps and their relationship to IEC 80001-1 and ISO 14971
- 8 Practical examples [Go to Page]
- 8.1 General
- 8.2 Example 1: Wireless patient monitoring during patient transport [Go to Page]
- 8.2.1 Full description of context
- 8.2.2 Description of network under analysis
- 8.2.3 The 10 Steps
- 8.3 Example 2: Remote ICU / Distance medicine [Go to Page]
- 8.3.1 Full description of context
- 8.3.2 Description of network under analysis
- 8.3.3 The 10 Steps
- 8.4 Example 3: Post Anesthesia Care Unit (PACU) [Go to Page]
- 8.4.1 Full description of context
- 8.4.2 Description of network under analysis
- 8.4.3 The 10 Steps
- 8.5 Example 4: Ultrasound – Operating System (OS) vulnerability [Go to Page]
- 8.5.1 Full description of context
- 8.5.2 Description of network under analysis
- 8.5.3 The 10 Steps
- Annex A (informative) Common hazards, hazardous situations, and causes to consider in medical IT-networks [Go to Page]
- A.1 Typical hazards in medical it-networks
- A.2 Types of hazardous situations
- A.3 Common causes in medical IT-networks
- A.4 Relationship between required network characteristics and hazards
- A.5 Relationship between hazards, foreseeable sequences, and causes
- A.6 Hazards, causes, foreseeable sequences, and hazardous situations
- Annex B (informative) List of questions to consider when identifying hazards of the medical IT-network
- Annex C (informative) Layers of medical IT-networks where errors can be found [Go to Page]
- C.1 Overview
- C.2 Errors and faults
- Annex D (informative) Probability, severity, and risk acceptability scales used in the examples in this technical report
- Annex E (informative) Monitoring risk mitigation effectiveness [Go to Page]
- E.1 Overview
- E.2 Verify the effectiveness of risk control measures
- E.3 Verify the effectiveness of inherent key property control by design
- E.4 Verify the effectiveness of protective measures
- E.5 Verify the effectiveness of information for key properties to mitigate risk
- E.6 Verification of the design and execution of the risk management process
- Annex F (informative) Risk analyzing small changes in a medical IT-network
- Annex G (informative) Example of Change Window Form
- Annex H (informative) Template for examples
- Bibliography [Go to Page]