{"id":593874,"date":"2024-11-05T21:33:29","date_gmt":"2024-11-05T21:33:29","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-149712019\/"},"modified":"2024-11-05T21:33:29","modified_gmt":"2024-11-05T21:33:29","slug":"iso-149712019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-149712019\/","title":{"rendered":"ISO 14971:2019"},"content":{"rendered":"

This document specifies terminology, principles and a process<\/i> for risk management<\/i> of medical devices<\/i>, including software as a medical device<\/i> and in vitro diagnostic<\/i> medical devices<\/i>. The process<\/i> described in this document intends to assist manufacturers<\/i> of medical devices<\/i> to identify the hazards<\/i> associated with the medical device<\/i>, to estimate and evaluate the associated risks<\/i>, to control these risks<\/i>, and to monitor the effectiveness of the controls.<\/p>\n

The requirements of this document are applicable to all phases of the life cycle<\/i> of a medical device<\/i>. The process<\/i> described in this document applies to risks<\/i> associated with a medical device<\/i>, such as risks<\/i> related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.<\/p>\n

The process<\/i> described in this document can also be applied to products that are not necessarily medical devices<\/i> in some jurisdictions and can also be used by others involved in the medical device<\/i> life cycle<\/i>.<\/p>\n

This document does not apply to:<\/p>\n

\u2014 decisions on the use of a medical device<\/i> in the context of any particular clinical procedure<\/i>; or<\/p>\n

\u2014 business risk management<\/i>.<\/p>\n

This document requires manufacturers<\/i> to establish objective criteria for risk<\/i> acceptability but does not specify acceptable risk<\/i> levels.<\/p>\n

Risk management<\/i> can be an integral part of a quality management system. However, this document does not require the manufacturer<\/i> to have a quality management system in place.<\/p>\n

NOTE Guidance on the application of this document can be found in ISO\/TR 24971[<\/sup>9<\/sup>]<\/sup>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Medical devices \u2014 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
ISO<\/b><\/a><\/td>\n2019-12<\/td>\n46<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":593885,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2634],"product_tag":[],"class_list":{"0":"post-593874","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-iso","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\/593874","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\/593885"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=593874"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=593874"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=593874"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}