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Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

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PDF Pages	PDF Title
1	ANSI/AAMI/ISO 14971:2019; Medical devices—Application of risk management to medical devices
3	Title page
4	AAMI Standard Copyright information
5	Contents
6	Committee representation
8	Background of ANSI/AAMI adoption of ISO 14971:2019
9	Foreword
11	Introduction
13	1 Scope 2 Normative references 3 Terms and definitions
19	4 General requirements for risk management system 4.1 Risk management process
21	Figure 1 — A schematic representation of the risk management process 4.2 Management responsibilities
22	4.3 Competence of personnel 4.4 Risk management plan
23	4.5 Risk management file 5 Risk analysis 5.1 Risk analysis process
24	5.2 Intended use and reasonably foreseeable misuse 5.3 Identification of characteristics related to safety 5.4 Identification of hazards and hazardous situations
25	5.5 Risk estimation 6 Risk evaluation
26	7 Risk control 7.1 Risk control option analysis 7.2 Implementation of risk control measures
27	7.3 Residual risk evaluation 7.4 Benefit-risk analysis 7.5 Risks arising from risk control measures 7.6 Completeness of risk control
28	8 Evaluation of overall residual risk 9 Risk management review 10 Production and post-production activities 10.1 General
29	10.2 Information collection 10.3 Information review 10.4 Actions
31	Annex A (informative) Rationale for requirements A.1 General A.2 Rationale for requirements in particular clauses and subclauses A.2.1 Scope
32	A.2.2 Normative references A.2.3 Terms and definitions
33	A.2.4 General requirements for risk management system A.2.4.1 Risk management process A.2.4.2 Management responsibilities
34	A.2.4.3 Competence of personnel A.2.4.4 Risk management plan
35	A.2.4.5 Risk management file A.2.5 Risk analysis A.2.5.1 Risk analysis process A.2.5.2 Intended use and reasonably foreseeable misuse A.2.5.3 Identification of characteristics related to safety A.2.5.4 Identification of hazards and hazardous situations
36	A.2.5.5 Risk estimation A.2.6 Risk evaluation A.2.7 Risk control A.2.7.1 Risk control option analysis A.2.7.2 Implementation of risk control measures
37	A.2.7.3 Residual risk evaluation A.2.7.4 Benefit-risk analysis A.2.7.5 Risks arising from risk control measures A.2.7.6 Completeness of risk control A.2.8 Evaluation of overall residual risk A.2.9 Risk management review
38	A.2.10 Production and post-production activities
39	Annex B (informative) Risk management process for medical devices B.1 Correspondence between second and third editions Table B.1 — Correspondence between elements of ISO 14971:2007 and ISO 14971:2019
41	B.2 Risk management process overview
42	Figure B.1 — Overview of risk management activities as applied to medical devices
43	Annex C (informative) Fundamental risk concepts C.1 General Figure C.1 — Pictorial example of the relationship between hazard, sequence of events, hazardous situation and harm (from ISO/IEC Guide 63:2019[2])
44	C.2 Examples of hazards
45	Table C.1 — Examples of hazards
46	C.3 Examples of events and circumstances Table C.2 — Examples of events and circumstances
47	C.4 Examples of relationships between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur
48	Table C.3 — Relationship between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur
49	Bibliography

Published By	Publication Date	Number of Pages
AAMI	2019	49


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Standard Title	ANSI/AAMI/ ISO 14971:2019 – Medical devices-Application of risk management to medical devices
Published Code	AAMI
Publication Date	2019
Pages Count	49

AAMI 14971 2019

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