{"id":3907,"date":"2019-10-22T09:07:54","date_gmt":"2019-10-22T07:07:54","guid":{"rendered":"http:\/\/medtech-ingenieur.de\/?p=3907"},"modified":"2021-08-06T14:36:46","modified_gmt":"2021-08-06T13:36:46","slug":"das-sicherheitskonzept-in-der-medizingeraete-entwicklung","status":"publish","type":"post","link":"https:\/\/medtech-ingenieur.de\/en\/das-sicherheitskonzept-in-der-medizingeraete-entwicklung\/","title":{"rendered":"The safety concept in medical device development"},"content":{"rendered":"<p>The security concept is one of the important concept documents that we create as part of product development.<\/p>\n<p>The safety concept describes why a device is safe and how safety is ensured in the event of a fault. Various aspects are considered, such as<\/p>\n<ul>\n<li>Mechanical safety<\/li>\n<li>Electrical safety<\/li>\n<li>Biological safety and biocompatibility<\/li>\n<li>Security regarding functionality<\/li>\n<li>Security of communication interfaces<\/li>\n<li>Further measures may address electromagnetic compatibility, heat generation, and radiation, depending on the type of device.<\/li>\n<\/ul>\n<h3>reader<\/h3>\n<p>The security concept is a system-level document.<br \/>\nThe security concept is created by the system architect or a developer with an overview of the security measures and concepts in the areas of mechanics, hardware and software.<\/p>\n<p>The readers of the security concept are system architects, developers and the notified body.<\/p>\n<h3>Contents<\/h3>\n<div class=\"table-scrollable\">\n<table>\n<tbody>\n<tr>\n<th>Theme<\/th>\n<th>Description<\/th>\n<th>Useful questions<\/th>\n<\/tr>\n<tr>\n<td>Introduction and General<\/td>\n<td>This chapter contains a general description of the device.<\/p>\n<ul>\n<li>Determination of the object to be protected and the protection objectives<\/li>\n<li>Referenced documents<\/li>\n<li>Definition of terms<\/li>\n<\/ul>\n<\/td>\n<td>\n<ul>\n<li>How and by whom is the device used?<\/li>\n<li>Where is the device used?<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<td>Block diagram<\/td>\n<td>Schematic representation of the device with important functional blocks<\/td>\n<td>Should internal and external interfaces be clearly identifiable?<\/td>\n<\/tr>\n<tr>\n<td>System context<\/td>\n<td>The system context shows the boundaries of the system. You can see an example in the image below (click to enlarge) and a short description can also be found in our article on <a href=\"https:\/\/medtech-ingenieur.de\/en\/system-architektur\/\">System architecture<\/a>. You&#039;ll also find more useful questions in the article.<\/p>\n<p><a href=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-329 size-medium\" src=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext-300x177.png\" alt=\"Systemkontext\" width=\"300\" height=\"177\" srcset=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext-300x177.png 300w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext-100x59.png 100w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext-150x89.png 150w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext-200x118.png 200w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext-450x266.png 450w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext-600x354.png 600w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext-768x454.png 768w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2015\/08\/systemContext.png 821w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><\/td>\n<td>Which device is it?<br \/>\nWhat functions does the device have?<br \/>\nWhere and by whom is it used?<br \/>\nClassification of the device<\/td>\n<\/tr>\n<tr>\n<td>Device states<\/td>\n<td>The different device states should be described and assessed with regard to their impact on safety.<br \/>\nExamples of device states are:<\/p>\n<ul>\n<li>Normal operation<\/li>\n<li>Safe condition<\/li>\n<li>Error condition<\/li>\n<li>Self-test<\/li>\n<li>Standby<\/li>\n<\/ul>\n<\/td>\n<td>What states does the device recognize?<\/td>\n<\/tr>\n<tr>\n<td>Security measures<\/td>\n<td>The safety concept should, of course, also present the measures that ensure the device&#039;s safety. There are various types of safety, including ensuring that no danger is posed to patients and operators. Data security should also be considered.<\/p>\n<p>Topics in this chapter include:<\/p>\n<ul>\n<li>Electrical safety\n<ul>\n<li>Clearances and creepage distances<\/li>\n<li>Isolation measures<\/li>\n<li>Classification of application parts<\/li>\n<\/ul>\n<\/li>\n<li>Mechanical safety\n<ul>\n<li>Stability<\/li>\n<\/ul>\n<\/li>\n<li>Biological safety\n<ul>\n<li>Biocompatibility according to ISO 10993 for parts that come into contact with the patient<\/li>\n<\/ul>\n<\/li>\n<li>Protection of communication interfaces\n<ul>\n<li>E.g. about passwords<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/td>\n<td>What measures are in place to ensure the electrical, mechanical and biological safety of the device?<\/p>\n<p>Has the security of important data been taken into account?<\/p>\n<p>Can configuration parameters be changed?<\/p>\n<p>Are there external interfaces that need to be secured?<\/td>\n<\/tr>\n<tr>\n<td>Further steps to identify risks and measures<\/td>\n<td>Other procedures for identifying risks and measures may be described, such as FMEA, risk analysis, independent audits, etc.<\/td>\n<td>What risk identification and management measures are in place in the project or for the device?<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<h3>Conclusion<\/h3>\n<p>The safety concept is an important document and, in the document hierarchy, is on the same level as the system specification. Naturally, there are areas of overlap, and like any concept document, it is always highly dependent on the type of development project. Is it a new development or an enhancement? How many units will the device be sold in? In which markets will it be sold? How critical is the device for the patient or user? The more dangerous a system, the more important the safety concept. All of this influences the scope, content, and depth of the safety concept.<\/p>\n<p>If you need support, for example, through external reviews, please call us or send us an email anytime. We&#039;re happy to assist you with your medical device.<\/p>\n<p>Best regards<\/p>\n<p>Martin Bosch<\/p>","protected":false},"excerpt":{"rendered":"<p>Das Sicherheitskonzept ist eines der wichtigen Konzeptpapiere, die wir im Rahmen der Produktentwicklung erstellen. Das Sicherheitskonzept beschreibt, warum ein Ger\u00e4t sicher ist und wie die Sicherheit im Fehlerfall gew\u00e4hrleistet wird. Dabei werden verschiedene Aspekte betrachtet wie Mechanische Sicherheit Elektrische Sicherheit Biologische Sicherheit und Biokompatibilit\u00e4t Sicherheit hinsichtlich der Funktionalit\u00e4t Sicherheit der Kommunikationsschnittstellen Weitere Ma\u00dfnahmen k\u00f6nnen elektromagnetische [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":329,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,7,8],"tags":[223,27,23,368],"class_list":["post-3907","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dokumentation","category-hardware-entwicklung","category-systemarchitekten","category-tools","tag-60601-1","tag-dokumentation","tag-medizintechnik","tag-sicherheitskonzept","post-wrapper","thrv_wrapper"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Das Sicherheitskonzept in der Medizinger\u00e4te-Entwicklung - MEDtech Ingenieur GmbH<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/medtech-ingenieur.de\/en\/das-sicherheitskonzept-in-der-medizingeraete-entwicklung\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Das Sicherheitskonzept in der Medizinger\u00e4te-Entwicklung - MEDtech Ingenieur GmbH\" \/>\n<meta property=\"og:description\" content=\"Das Sicherheitskonzept ist eines der wichtigen Konzeptpapiere, die wir im Rahmen der Produktentwicklung erstellen. Das Sicherheitskonzept beschreibt, warum ein Ger\u00e4t sicher ist und wie die Sicherheit im Fehlerfall gew\u00e4hrleistet wird. 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