{"id":198244,"date":"2024-10-19T12:37:13","date_gmt":"2024-10-19T12:37:13","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-14971-2019\/"},"modified":"2024-10-25T05:10:21","modified_gmt":"2024-10-25T05:10:21","slug":"aami-14971-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-14971-2019\/","title":{"rendered":"AAMI 14971 2019"},"content":{"rendered":"

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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 14971:2019; Medical devices\u2014Application of risk management to medical devices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of ISO 14971:2019 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
19<\/td>\n4 General requirements for risk management system
4.1 Risk management process <\/td>\n<\/tr>\n
21<\/td>\nFigure 1 \u2014 A schematic representation of the risk management process
4.2 Management responsibilities <\/td>\n<\/tr>\n
22<\/td>\n4.3 Competence of personnel
4.4 Risk management plan <\/td>\n<\/tr>\n
23<\/td>\n4.5 Risk management file
5 Risk analysis
5.1 Risk analysis process <\/td>\n<\/tr>\n
24<\/td>\n5.2 Intended use and reasonably foreseeable misuse
5.3 Identification of characteristics related to safety
5.4 Identification of hazards and hazardous situations <\/td>\n<\/tr>\n
25<\/td>\n5.5 Risk estimation
6 Risk evaluation <\/td>\n<\/tr>\n
26<\/td>\n7 Risk control
7.1 Risk control option analysis
7.2 Implementation of risk control measures <\/td>\n<\/tr>\n
27<\/td>\n7.3 Residual risk evaluation
7.4 Benefit-risk analysis
7.5 Risks arising from risk control measures
7.6 Completeness of risk control <\/td>\n<\/tr>\n
28<\/td>\n8 Evaluation of overall residual risk
9 Risk management review
10 Production and post-production activities
10.1 General <\/td>\n<\/tr>\n
29<\/td>\n10.2 Information collection
10.3 Information review
10.4 Actions <\/td>\n<\/tr>\n
31<\/td>\nAnnex A (informative) Rationale for requirements
A.1 General
A.2 Rationale for requirements in particular clauses and subclauses
A.2.1 Scope <\/td>\n<\/tr>\n
32<\/td>\nA.2.2 Normative references
A.2.3 Terms and definitions <\/td>\n<\/tr>\n
33<\/td>\nA.2.4 General requirements for risk management system
A.2.4.1 Risk management process
A.2.4.2 Management responsibilities <\/td>\n<\/tr>\n
34<\/td>\nA.2.4.3 Competence of personnel
A.2.4.4 Risk management plan <\/td>\n<\/tr>\n
35<\/td>\nA.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 <\/td>\n<\/tr>\n
36<\/td>\nA.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 <\/td>\n<\/tr>\n
37<\/td>\nA.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 <\/td>\n<\/tr>\n
38<\/td>\nA.2.10 Production and post-production activities <\/td>\n<\/tr>\n
39<\/td>\nAnnex B (informative) Risk management process for medical devices
B.1 Correspondence between second and third editions
Table B.1 \u2014 Correspondence between elements of ISO 14971:2007 and ISO 14971:2019 <\/td>\n<\/tr>\n
41<\/td>\nB.2 Risk management process overview <\/td>\n<\/tr>\n
42<\/td>\nFigure B.1 \u2014 Overview of risk management activities as applied to medical devices <\/td>\n<\/tr>\n
43<\/td>\nAnnex C (informative) Fundamental risk concepts
C.1 General
Figure C.1 \u2014 Pictorial example of the relationship between hazard, sequence of events, hazardous situation and harm (from ISO\/IEC Guide 63:2019[2]) <\/td>\n<\/tr>\n
44<\/td>\nC.2 Examples of hazards <\/td>\n<\/tr>\n
45<\/td>\nTable C.1 \u2014 Examples of hazards <\/td>\n<\/tr>\n
46<\/td>\nC.3 Examples of events and circumstances
Table C.2 \u2014 Examples of events and circumstances <\/td>\n<\/tr>\n
47<\/td>\nC.4 Examples of relationships between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur <\/td>\n<\/tr>\n
48<\/td>\nTable C.3 \u2014 Relationship between hazards, foreseeable sequences of events, hazardous situations and the harm that can occur <\/td>\n<\/tr>\n
49<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ ISO 14971:2019 – Medical devices-Application of risk management to medical devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n49<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198249,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198244","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198244","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198249"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198244"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198244"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198244"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}