{"id":9864,"date":"2022-05-10T09:11:57","date_gmt":"2022-05-10T07:11:57","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=9864"},"modified":"2022-06-10T09:21:58","modified_gmt":"2022-06-10T07:21:58","slug":"hazard-and-risk","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2022\/05\/10\/hazard-and-risk\/","title":{"rendered":"Hazards and risks: This applies in risk management for medical devices"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-f3aw9n-a86ee9c7109a8d0e8db27099d1846d29\">\n.avia-section.av-f3aw9n-a86ee9c7109a8d0e8db27099d1846d29{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_129913760-scaled.jpg);\nbackground-position:0% 0%;\nbackground-attachment:scroll;\n}\n.avia-section.av-f3aw9n-a86ee9c7109a8d0e8db27099d1846d29 .av-section-color-overlay{\nopacity:0.5;\nbackground-color:#5b5b5b;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-f3aw9n-a86ee9c7109a8d0e8db27099d1846d29 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='550'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' style='height:550px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9864'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id='av_section_2'  class='avia-section av-vc96j-73e56fe94a849d655dc1094b25ecdf20 main_color avia-section-default avia-no-border-styling  avia-builder-el-1  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9864'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-419jsb-e0ca5858278da3a00b82fb92cd4f0f48\">\n.flex_column.av-419jsb-e0ca5858278da3a00b82fb92cd4f0f48{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-419jsb-e0ca5858278da3a00b82fb92cd4f0f48 av_one_fifth  avia-builder-el-2  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-76oet7-63ca99088c885b6e5ffde33022dbe4da\">\n.flex_column.av-76oet7-63ca99088c885b6e5ffde33022dbe4da{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-76oet7-63ca99088c885b6e5ffde33022dbe4da av_three_fifth  avia-builder-el-3  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l4843ko0-1b7e9df73bf74ea2afb462af8b90e417\">\n#top .av-special-heading.av-l4843ko0-1b7e9df73bf74ea2afb462af8b90e417{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l4843ko0-1b7e9df73bf74ea2afb462af8b90e417 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l4843ko0-1b7e9df73bf74ea2afb462af8b90e417 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l4843ko0-1b7e9df73bf74ea2afb462af8b90e417 av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-4  el_before_av_hr  avia-builder-el-first '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Hazards and risks: This applies in risk management for medical devices<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l324tmrf-fe85b91b6f816db2d08112a16e73079e\">\n#top .hr.hr-invisible.av-l324tmrf-fe85b91b6f816db2d08112a16e73079e{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l324tmrf-fe85b91b6f816db2d08112a16e73079e hr-invisible  avia-builder-el-5  el_after_av_heading  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-l30a8pco-d9e112ec483b6c18d37d0137b556536e '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p style=\"text-align: center\">There is a difference between a hazard, a hazardous situation and a risk &#8211; not only according to ISO 14971. Particularly in the field of medical technology, a comparison of the terms is necessary, as manufacturers must carry out a risk analysis in the risk management process. What criteria should be used to make a distinction? And how you can create a risk analysis? We present it to you.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8r2hn-2fa6dafc8db3c18f16020a7fc965c69b\">\n.flex_column.av-8r2hn-2fa6dafc8db3c18f16020a7fc965c69b{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-8r2hn-2fa6dafc8db3c18f16020a7fc965c69b av_one_fifth  avia-builder-el-7  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb\">\n.avia-section.av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb alternate_color avia-section-default avia-no-border-styling  avia-builder-el-8  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9864'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-76oet7-c13c76d532c04fca1296a1a6db9b0a5a\">\n.flex_column.av-76oet7-c13c76d532c04fca1296a1a6db9b0a5a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-76oet7-c13c76d532c04fca1296a1a6db9b0a5a av_three_fifth  avia-builder-el-9  el_before_av_two_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>Hazards<\/strong><\/p>\n<p>A possible hazard exists when damage can occur due to external causes. For example, if a defective medical device triggers an electric shock or if chemical substances escape in an accident.<\/p>\n<p>According to ISO 14971, the term hazard includes in principle: chemical, thermal or biological hazards, electrical or mechanical energy, electromagnetic radiation and also hazards due to (incorrect) information (e.g. through manuals).<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l324tmrf-fe85b91b6f816db2d08112a16e73079e\">\n#top .hr.hr-invisible.av-l324tmrf-fe85b91b6f816db2d08112a16e73079e{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l324tmrf-fe85b91b6f816db2d08112a16e73079e hr-invisible  avia-builder-el-11  el_after_av_textblock  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>Risk<\/strong><\/p>\n<p>A risk, on the other hand, is the probability that a person will be injured or property damage will occur as a result of a hazardous situation. Because a medical device is used on or in a human being, it always carries a certain degree of risk.<\/p>\n<p>How high this risk is is illustrated by manufacturers in the <a href=\"https:\/\/www.riskmanager.net\/en\/solution\/the-validated-approval-accelerator\/\" target=\"_blank\" rel=\"noopener\">risk management file<\/a>.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5wktfv-53f3b7aaecb3f7dc5ec61ec147e61c82\">\n.flex_column.av-5wktfv-53f3b7aaecb3f7dc5ec61ec147e61c82{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5wktfv-53f3b7aaecb3f7dc5ec61ec147e61c82 av_two_fifth  avia-builder-el-13  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><article  class='iconbox iconbox_top av-l30ace0e-92b04424743702359c17547696dbe8a0  avia-builder-el-14  avia-builder-el-no-sibling  main_color'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Good to know\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue864' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Good to know<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>ISO 14971 also distinguishes between the terms hazard and hazardous situation. The former represents a potential source of damage. The hazardous situation, on the other hand, is the actual moment when persons or material objects are exposed to a hazard.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_4'  class='avia-section av-afq4r-708003752ba960f04e49bf1cb7fa335f main_color avia-section-default avia-no-border-styling  avia-builder-el-15  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9864'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_three_fifth  avia-builder-el-16  el_before_av_two_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l48474o8-0769322e14049756fd4dcbeaab3bbe6e\">\n#top .av-special-heading.av-l48474o8-0769322e14049756fd4dcbeaab3bbe6e{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l48474o8-0769322e14049756fd4dcbeaab3bbe6e .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l48474o8-0769322e14049756fd4dcbeaab3bbe6e .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l48474o8-0769322e14049756fd4dcbeaab3bbe6e av-special-heading-h2 blockquote modern-quote  avia-builder-el-17  el_before_av_hr  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Risk management for medical devices and in vitro diagnostics &#8211; what applies?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1\">\n#top .hr.hr-invisible.av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1 hr-invisible  avia-builder-el-18  el_after_av_heading  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2bgywr-3b2aa58bf488bb866a0aecd278116c27\">\n.flex_column.av-2bgywr-3b2aa58bf488bb866a0aecd278116c27{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2bgywr-3b2aa58bf488bb866a0aecd278116c27 av_two_fifth  avia-builder-el-19  el_after_av_three_fifth  el_before_av_two_fifth  flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2bgywr-907b9fb9f5c880948ee416dae52e96ba\">\n.flex_column.av-2bgywr-907b9fb9f5c880948ee416dae52e96ba{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2bgywr-907b9fb9f5c880948ee416dae52e96ba av_two_fifth  avia-builder-el-20  el_after_av_two_fifth  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30amg86-ca65345a405cea63e75b0b4a91edb4af\">\n.avia-image-container.av-l30amg86-ca65345a405cea63e75b0b4a91edb4af img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-l30amg86-ca65345a405cea63e75b0b4a91edb4af .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-l30amg86-ca65345a405cea63e75b0b4a91edb4af av-styling- avia-align-center  avia-builder-el-21  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-9893 avia-img-lazy-loading-not-9893 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_164724209-scaled.jpg\" alt='In-Vitro-Diagnistika' title='shutterstock_164724209'  height=\"1706\" width=\"2560\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_164724209-scaled.jpg 2560w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_164724209-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_164724209-1030x687.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_164724209-768x512.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_164724209-1536x1024.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_164724209-2048x1365.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_164724209-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_164724209-705x470.jpg 705w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7\">\n.flex_column.av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7 av_three_fifth  avia-builder-el-22  el_after_av_two_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The requirements of ISO 14971 in the risk management process for medical devices and in vitro diagnostic medical devices are standardised for Europe and the USA. For manufacturers, this means that during the entire product life cycle, a procedure must be followed to ensure that<\/p>\n<ul>\n<li>hazards emanating from the medical device and its accessories are identified<\/li>\n<li>risks are assessed, evaluated and controlled, and the<\/li>\n<li>the effectiveness of the controls is monitored<\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb\">\n.avia-section.av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_5'  class='avia-section av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb alternate_color avia-section-default avia-no-border-styling  avia-builder-el-24  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9864'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_three_fifth  avia-builder-el-25  el_before_av_four_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l484870d-ff2066131e80ce2fcf867cc5312061b5\">\n#top .av-special-heading.av-l484870d-ff2066131e80ce2fcf867cc5312061b5{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l484870d-ff2066131e80ce2fcf867cc5312061b5 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l484870d-ff2066131e80ce2fcf867cc5312061b5 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l484870d-ff2066131e80ce2fcf867cc5312061b5 av-special-heading-h2 blockquote modern-quote  avia-builder-el-26  el_before_av_hr  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Preliminary Hazard Analysis (PHA)<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1\">\n#top .hr.hr-invisible.av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1 hr-invisible  avia-builder-el-27  el_after_av_heading  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_four_fifth  avia-builder-el-28  el_after_av_three_fifth  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Identifying safety-critical areas at an early stage is the goal of PHA. In the process, a higher-level hazard assessment is created in order to be able to define subsequent hazard controls and resulting measures.<\/p>\n<p>One advantage of PHA: risk management is part of the process from the beginning of the product life cycle, because PHA is used both in the requirements analysis and in early phases of the design process of your medical device. Another advantage: costs can potentially be saved by identifying risks at an early stage.<\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_6'  class='avia-section av-27n5hn-c7cc5b4db77dfca597f3eb4f2c4d452b main_color avia-section-default avia-no-border-styling  avia-builder-el-30  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9864'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-bda26f5e0801b26af0a36c686d542db0\">\n.flex_column.av-3kietn-bda26f5e0801b26af0a36c686d542db0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-bda26f5e0801b26af0a36c686d542db0 av_one_fifth  avia-builder-el-31  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-ed580c12b4bf0ff292a78251c959e392\">\n@keyframes av_boxShadowEffect_av-3kietn-ed580c12b4bf0ff292a78251c959e392-column {\n0%   { box-shadow:  0 0 0 0 #e5e5e5; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 #e5e5e5; opacity: 1; }\n}\n.flex_column.av-3kietn-ed580c12b4bf0ff292a78251c959e392{\nbox-shadow: 0 0 10px 0 #e5e5e5;\nborder-width:1px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:12px 12px 12px 12px;\npadding:15px 15px 15px 15px;\nbackground-color:#99c1bc;\n}\n<\/style>\n<div  class='flex_column av-3kietn-ed580c12b4bf0ff292a78251c959e392 av_three_fifth  avia-builder-el-32  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div shadow-not-animated  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30a9f68-65fce345849e55be7cc6a624f3526837\">\n#top .av_textblock_section.av-l30a9f68-65fce345849e55be7cc6a624f3526837 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-l30a9f68-65fce345849e55be7cc6a624f3526837 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: center\"><strong>FMEA and Hazard Analysis: <\/strong><strong>What is the difference?<\/strong><\/p>\n<p style=\"text-align: center\"><strong>Read more about it now in our blog<\/strong><strong>.<\/strong><\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30avg2y-76d264f2f03dd6afabbd57a7bfe18725\">\n#top .hr.hr-invisible.av-l30avg2y-76d264f2f03dd6afabbd57a7bfe18725{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-l30avg2y-76d264f2f03dd6afabbd57a7bfe18725 hr-invisible  avia-builder-el-34  el_after_av_textblock  el_before_av_button '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-l30aw29k-3ca78dc6a49c5fa8a408bbf9224a1924-wrap avia-button-center  avia-builder-el-35  el_after_av_hr  avia-builder-el-last '><a href='https:\/\/www.riskmanager.net\/2022\/04\/11\/fmea-und-pha-unterschied'  class='avia-button av-l30aw29k-3ca78dc6a49c5fa8a408bbf9224a1924 av-link-btn avia-icon_select-no avia-size-x-large avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Blog\"><span class='avia_iconbox_title' >Blog<\/span><\/a><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7\">\n.flex_column.av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3kietn-8b1fe131d656a6cfb4e9f4b947dc28b7 av_one_fifth  avia-builder-el-36  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb\">\n.avia-section.av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb{\nbackground-color:#595959;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_7'  class='avia-section av-l30aauke-376cd71f9c930d1b720c62e1f1034dbb alternate_color avia-section-default avia-no-border-styling  avia-builder-el-37  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9864'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2e4k9n-8cfc1d1bd956671f0787a276db4b69a0\">\n.flex_column.av-2e4k9n-8cfc1d1bd956671f0787a276db4b69a0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2e4k9n-8cfc1d1bd956671f0787a276db4b69a0 av_four_fifth  avia-builder-el-38  el_before_av_one_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-l30a9f68-beb96065104bd0e4c451042b7c031e97 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The BAYOOSOFT Risk Manager in the basic module offers you the possibility of recognising hazardous situations at an early stage. This is because Preliminary Hazard Analysis is fully integrated in our specialised solution. You decide for each project:<\/p>\n<ul>\n<li>Use of a previously defined global template of the risk graph or<\/li>\n<li>Individual adaptation with regard to probability of occurrence and extent of damage<\/li>\n<\/ul>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-73tqtn-a1ba6031a1a6481329941b2942e834b4\">\n.flex_column.av-73tqtn-a1ba6031a1a6481329941b2942e834b4{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-73tqtn-a1ba6031a1a6481329941b2942e834b4 av_one_fifth  avia-builder-el-40  el_after_av_four_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-73tqtn-65d654cc24eae9d34a1a406212e66978\">\n.flex_column.av-73tqtn-65d654cc24eae9d34a1a406212e66978{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-73tqtn-65d654cc24eae9d34a1a406212e66978 av_one_fifth  avia-builder-el-41  el_after_av_one_fifth  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-73tqtn-a1ba6031a1a6481329941b2942e834b4\">\n.flex_column.av-73tqtn-a1ba6031a1a6481329941b2942e834b4{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-73tqtn-a1ba6031a1a6481329941b2942e834b4 av_three_fifth  avia-builder-el-42  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><p><div  class='avia-button-wrap av-l30aw29k-d7eb5f4ce4c7b436bbf89803b9bd6c9c-wrap avia-button-center  avia-builder-el-43  el_before_av_hr  avia-builder-el-first '><a href='https:\/\/www.riskmanager.net\/en\/modules-features\/features\/'  class='avia-button av-l30aw29k-d7eb5f4ce4c7b436bbf89803b9bd6c9c av-link-btn avia-icon_select-no avia-size-x-large avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"mehr erfahren\"><span class='avia_iconbox_title' >mehr erfahren<\/span><\/a><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1\">\n#top .hr.hr-invisible.av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1{\nheight:40px;\n}\n<\/style>\n<div  class='hr av-l3251g6b-d3f0ee3f763593ecd0853a187c7ef5a1 hr-invisible  avia-builder-el-44  el_after_av_button  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-73tqtn-a1ba6031a1a6481329941b2942e834b4\">\n.flex_column.av-73tqtn-a1ba6031a1a6481329941b2942e834b4{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-73tqtn-a1ba6031a1a6481329941b2942e834b4 av_one_fifth  avia-builder-el-45  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_8'  class='avia-section av-av_section-e20e11b232c33ea52312394292f0d9a7 main_color avia-section-default avia-no-border-styling  avia-builder-el-46  el_after_av_section  avia-builder-el-last  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9864'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5lt33v-d63609e58a69f1b968e641a03da4916f\">\n.flex_column.av-5lt33v-d63609e58a69f1b968e641a03da4916f{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-5lt33v-d63609e58a69f1b968e641a03da4916f av_one_fifth  avia-builder-el-47  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4q896j-986c4534337738df611a2a9d356d3194\">\n.flex_column.av-4q896j-986c4534337738df611a2a9d356d3194{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4q896j-986c4534337738df611a2a9d356d3194 av_three_fifth  avia-builder-el-48  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><div  class='av-social-sharing-box av-l325cw4w-53f7c3a545d8488ff7e7d9b6c79a2410 av-social-sharing-box-minimal  avia-builder-el-49  avia-builder-el-no-sibling  av-social-sharing-box-fullwidth'><div class=\"av-share-box\"><h5 class='av-share-link-description av-no-toc '>Sounds interesting? 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