{"id":390898,"date":"2024-10-20T03:56:50","date_gmt":"2024-10-20T03:56:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-149712019a112021\/"},"modified":"2024-10-26T07:17:46","modified_gmt":"2024-10-26T07:17:46","slug":"bs-en-iso-149712019a112021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-149712019a112021\/","title":{"rendered":"BS EN ISO 14971:2019+A11:2021"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
14<\/td>\nForeword <\/td>\n<\/tr>\n
16<\/td>\nIntroduction <\/td>\n<\/tr>\n
19<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
25<\/td>\n4 General requirements for risk management system
4.1 Risk management process <\/td>\n<\/tr>\n
26<\/td>\n4.2 Management responsibilities <\/td>\n<\/tr>\n
27<\/td>\n4.3 Competence of personnel
4.4 Risk management plan <\/td>\n<\/tr>\n
28<\/td>\n4.5 Risk management file
5 Risk analysis
5.1 Risk analysis process
5.2 Intended use and reasonably foreseeable misuse <\/td>\n<\/tr>\n
29<\/td>\n5.3 Identification of characteristics related to safety
5.4 Identification of hazards and hazardous situations
5.5 Risk estimation <\/td>\n<\/tr>\n
30<\/td>\n6 Risk evaluation
7 Risk control
7.1 Risk control option analysis <\/td>\n<\/tr>\n
31<\/td>\n7.2 Implementation of risk control measures
7.3 Residual risk evaluation <\/td>\n<\/tr>\n
32<\/td>\n7.4 Benefit-risk analysis
7.5 Risks arising from risk control measures
7.6 Completeness of risk control
8 Evaluation of overall residual risk <\/td>\n<\/tr>\n
33<\/td>\n9 Risk management review
10 Production and post-production activities
10.1 General
10.2 Information collection <\/td>\n<\/tr>\n
34<\/td>\n10.3 Information review
10.4 Actions <\/td>\n<\/tr>\n
35<\/td>\nAnnex A (informative) Rationale for requirements <\/td>\n<\/tr>\n
44<\/td>\nAnnex B (informative) Risk management process for medical devices <\/td>\n<\/tr>\n
48<\/td>\nAnnex C (informative) Fundamental risk concepts <\/td>\n<\/tr>\n
54<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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
BSI<\/b><\/a><\/td>\n2021<\/td>\n56<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":390908,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-390898","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/390898","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\/390908"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=390898"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=390898"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=390898"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}