{"version":"1.0","provider_name":"\u898f\u683c\u30de\u30b9\u30bf\u30fc","provider_url":"https:\/\/kikakumaster.com\/ja\/","author_name":"KikakuAdmin000","author_url":"https:\/\/kikakumaster.com\/ja\/author\/kikakuadmin000\/","title":"IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices \u2014 Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - \u898f\u683c\u30de\u30b9\u30bf\u30fc","type":"rich","width":600,"height":338,"html":"<blockquote class=\"wp-embedded-content\" data-secret=\"o1lks6L8Wd\"><a href=\"https:\/\/kikakumaster.com\/ja\/iso\/iec-80001-1\/\">IEC 80001-1 &#8211; Application of risk management for IT-networks incorporating medical devices \u2014 Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software<\/a><\/blockquote><iframe sandbox=\"allow-scripts\" security=\"restricted\" src=\"https:\/\/kikakumaster.com\/ja\/iso\/iec-80001-1\/embed\/#?secret=o1lks6L8Wd\" width=\"600\" height=\"338\" title=\"&#8220;IEC 80001-1 &#8211; Application of risk management for IT-networks incorporating medical devices \u2014 Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software&#8221; &#8212; \u898f\u683c\u30de\u30b9\u30bf\u30fc\" data-secret=\"o1lks6L8Wd\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\" class=\"wp-embedded-content\"><\/iframe><script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\n\/*! This file is auto-generated *\/\n!function(d,l){\"use strict\";l.querySelector&&d.addEventListener&&\"undefined\"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!\/[^a-zA-Z0-9]\/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret=\"'+t.secret+'\"]'),o=l.querySelectorAll('blockquote[data-secret=\"'+t.secret+'\"]'),c=new RegExp(\"^https?:$\",\"i\"),i=0;i<o.length;i++)o[i].style.display=\"none\";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute(\"style\"),\"height\"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):\"link\"===t.message&&(r=new URL(s.getAttribute(\"src\")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener(\"message\",d.wp.receiveEmbedMessage,!1),l.addEventListener(\"DOMContentLoaded\",function(){for(var e,t,s=l.querySelectorAll(\"iframe.wp-embedded-content\"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute(\"data-secret\"))||(t=Math.random().toString(36).substring(2,12),e.src+=\"#?secret=\"+t,e.setAttribute(\"data-secret\",t)),e.contentWindow.postMessage({message:\"ready\",secret:t},\"*\")},!1)))}(window,document);\n\/\/# sourceURL=https:\/\/kikakumaster.com\/wp-includes\/js\/wp-embed.min.js\n\/* ]]> *\/\n<\/script>\n","description":"Application of risk management for IT-networks incorporating medical devices \u2014 Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders. IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT; c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and\/or HEALTH IT SYSTEMS."}