AAMI TIR105 2020

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AAMI TIR105:2020 Risk management guidance for combination products

Published By	Publication Date	Number of Pages
AAMI	2020

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Category: AAMI

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Description

This technical information report provides recommendations and processes to assist manufacturers of combination products in identifying hazards associated with the combination product, assessing associated risks, selecting options for controlling these risks, and monitoring the effectiveness of the implemented controls.

PDF Catalog

PDF Pages	PDF Title
1	AAMI TIR105:2020; Risk management guidance for combination products
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents
6	Committee representation
7	Foreword
8	Introduction
11	1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references 3 Terms and definitions
12	4 Risk management plan 4.1 General considerations
13	4.1.1 Description of combination product 4.1.2 Necessary expertise 4.2 Understanding of relevant standards and guidance 4.3 Integration of information from third-party vendors
14	4.4 Consideration of supply risk 4.5 Documentation and record-keeping 5 Risk assessment 5.1 Risk profile and assessment approach 5.1.1 Establishing an overall safety profile
15	5.1.2 Risk assessment inputs Table 1—Sources of input into risk assessment
17	5.1.3 Risk assessment approach 5.1.3.1 System-level vs. constituent-part-level risk assessment 5.1.3.2 Risk analysis tools 5.1.3.3 Documentation
18	5.2 Risk analysis 5.2.1 Integrated risk analysis 5.2.2 Hazard assessment and example of constituent contributions Table 2—Sample system-level risk assessment
19	Table 3—How individual risk analyses can be incorporated into a system-level risk analysis 5.2.3 Identification and understanding of events Table 4—Example of how one constituent’s failure can affect the other
20	5.2.4 Initial control effects 5.2.5 Proper definition of harm Table 5—Defining harm appropriately 5.2.5.1 Use of a “surrogate approach” Figure 1—Event chain
21	5.2.6 Resources and terminology 5.3 Risk evaluation 5.4 Risk analysis
22	6 Risk control Table 6—Approaches to risk control
24	7 Risk management report 8 Risk review monitoring 8.1 General considerations
25	Figure 2—Risk review 8.2 Risk review initiators and their evaluation
26	8.3 Review of risk management activities and documentation
27	Annex A (informative) Summary of requirements of ISO 14971, ICH Q9, and AAMI TIR48 Table A.1—Risk management plan Table A.2—Risk assessment
29	Table A.3—Risk control
30	Table A.4—Risk report
31	Table A.5—Risk review/monitoring
33	Annex B (informative) Combination product risk management utilizing a risk traceability summary
34	Figure B.1—Risk assessment trace matrix
35	Figure B.2—Tools and techniques used during the design process to perform risk analysis
36	Figure B.3—Streamlined risk management trace matrix
37	Table B.1—Risk management traceability Table B.2—Risk management traceability (page 2)
39	Bibliography