{"id":1894,"date":"2010-11-01T20:25:31","date_gmt":"2010-11-01T20:25:31","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=1894"},"modified":"2010-11-01T20:25:31","modified_gmt":"2010-11-01T20:25:31","slug":"iec-80001-1-1st-ed-application-of-risk-mgmt-for-it-networks-incorporating-med-dvcs","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2010\/11\/01\/iec-80001-1-1st-ed-application-of-risk-mgmt-for-it-networks-incorporating-med-dvcs\/","title":{"rendered":"IEC 80001-1 1st ed Application of Risk Mgmt for IT Networks Incorporating Med Dvcs"},"content":{"rendered":"

IEC 80001-1 edition 1 was published Oct 27, 2010 and is for the “Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities” <\/span><\/p>\n

The scope states, noting that all ALL CAPITAL words are defined either in this standard or other referenced standards:<\/span><\/span><\/p>\n

“<\/span><\/span>Recognizing that <\/span><\/span>MEDICAL DEVICES <\/span><\/span><\/span>are incorporated into IT-<\/span><\/span>NETWORKS <\/span><\/span><\/span>to achieve desirable benefits (for example, <\/span><\/span>INTEROPERABILITY<\/span><\/span><\/span>), this international standard defines the roles, responsibilities and activities that are necessary for <\/span><\/span>RISK MANAGEMENT <\/span><\/span><\/span>of IT-<\/span><\/span>NETWORKS <\/span><\/span><\/span>incorporating <\/span><\/span>MEDICAL DEVICES <\/span><\/span><\/span>to address <\/span><\/span>SAFETY<\/span><\/span><\/span>, <\/span><\/span>EFFECTIVENESS <\/span><\/span><\/span>and <\/span><\/span>DATA AND SYSTEM SECURITY <\/span><\/span><\/span>(the <\/span><\/span>KEY PROPERTIES<\/span><\/span><\/span>). This international standard does not specify acceptable <\/span><\/span>RISK <\/span><\/span><\/span>levels.<\/span><\/span><\/span><\/p>\n

NOTE 1<\/span><\/span> <\/span><\/span><\/span>The <\/span><\/span>RISK MANAGEMENT <\/span><\/span><\/span>activities described in this standard are derived from those in ISO 14971 [4]. The relationship between ISO 14971 and this standard is described in Annex A.<\/span><\/span><\/p>\n


\n <\/span><\/span><\/p>\n

This standard applies after a <\/span><\/span>MEDICAL DEVICE <\/span><\/span><\/span>has been acquired by a <\/span><\/span>RESPONSIBLE ORGANIZATION <\/span><\/span><\/span>and is a candidate for incorporation into an IT-<\/span><\/span>NETWORK<\/span><\/span><\/span>.<\/span><\/span><\/p>\n


\n <\/span><\/p>\n

NOTE 2<\/span><\/span> <\/span><\/span><\/span>This standard does not cover pre-market <\/span><\/span>RISK MANAGEMENT<\/span><\/span><\/span>. <\/span><\/span>This standard applies throughout the life cycle of IT-<\/span><\/span><\/span>NETWORKS <\/span><\/span>incorporating <\/span><\/span><\/span>MEDICAL DEVICES<\/span><\/span>.<\/span><\/span><\/span><\/p>\n


\n <\/span><\/p>\n

NOTE3 The life cycle management activities described in this standard are very similar to those of ISO\/IEC 20000-2 [10]. The relationship between ISO\/IEC 20000-2 and this standard is described in Annex D.<\/span><\/span><\/p>\n


\n <\/span><\/p>\n

This standard applies where there is no single <\/span><\/span>MEDICAL DEVICE <\/span><\/span><\/span>manufacturer assuming responsibility for addressing the <\/span><\/span>KEY <\/span><\/span><\/span><\/p>\n

PROPERTIES <\/span><\/span><\/span>of the IT-<\/span><\/span>NETWORK <\/span><\/span><\/span>incorporating a <\/span><\/span>MEDICAL DEVICE<\/span><\/span><\/span>.<\/span><\/span><\/p>\n


\n <\/span><\/p>\n

NOTE 4<\/span><\/span> <\/span><\/span><\/span>If a single manufacturer specifies a complete <\/span><\/span>MEDICAL DEVICE <\/span><\/span><\/span>that includes a network, the installation or assembly of the <\/span><\/span>MEDICAL DEVICE <\/span><\/span><\/span>according to the manufacturer\u2019s <\/span><\/span>ACCOMPANYING DOCUMENTS <\/span><\/span><\/span>is not subject to the provisions of this standard regardless of who installs or assembles the <\/span><\/span>MEDICAL DEVICE<\/span><\/span><\/span>.<\/span><\/span><\/p>\n


\n <\/span><\/p>\n

NOTE 5 If a single manufacturer specifies a complete <\/span><\/span>MEDICAL DEVICE <\/span><\/span><\/span>that includes a network, additions to that <\/span><\/span>MEDICAL DEVICE <\/span><\/span><\/span>or modification of the configuration of that <\/span><\/span>MEDICAL DEVICE<\/span><\/span><\/span>, other than as specified by the manufacturer, is subject to the provisions of this standard.<\/span><\/span><\/p>\n


\n <\/span><\/p>\n

This standard applies to <\/span><\/span>RESPONSIBLE ORGANIZATIONS<\/span><\/span><\/span>, <\/span><\/span>MEDICAL DEVICE <\/span><\/span><\/span>manufacturers and providers of other information technology for the purpose of <\/span><\/span>RISK MANAGEMENT <\/span><\/span><\/span>of an IT- <\/span><\/span>NETWORK <\/span><\/span><\/span>incorporating <\/span><\/span>MEDICAL DEVICES <\/span><\/span><\/span>as specified by the <\/span><\/span>RESPONSIBLE ORGANIZATION<\/span><\/span><\/span>.<\/span><\/span><\/p>\n


\n <\/span><\/p>\n

This standard does not apply to personal use applications where the patient, <\/span><\/span>OPERATOR <\/span><\/span><\/span>and <\/span><\/span>RESPONSIBLE ORGANIZATION <\/span><\/span><\/span>are one and the same person.<\/span><\/span><\/p>\n


\n <\/span><\/p>\n

NOTE 6 In cases where a <\/span><\/span>MEDICAL DEVICE <\/span><\/span><\/span>is used at home under the supervision or instruction of the provider, that provider is deemed to be the <\/span><\/span>RESPONSIBLE ORGANIZATION<\/span><\/span><\/span>. Personal use where the patient acquires and uses a <\/span><\/span>MEDICAL DEVICE <\/span><\/span><\/span>without the supervision or instruction of a provider is out of scope of this standard.<\/span><\/span><\/p>\n


\n <\/span><\/p>\n

This standard does not address regulatory or legal requirements.<\/span><\/span>“<\/span><\/span><\/p>\n

The information on this page is based from <\/span><\/span>IEC webstore<\/span><\/span><\/a> for IEC 80001-1, 1st ed.<\/span><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

IEC 80001-1 edition 1 was published Oct 27, 2010 and is for the “Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities” The scope states, noting that all ALL CAPITAL words are defined<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[13,239,240,71,149,151],"class_list":["post-1894","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-iec","tag-iec-80001-1","tag-it-networks","tag-medical-device-standards","tag-medical-devices","tag-medical-systems"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1894","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=1894"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1894\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=1894"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=1894"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=1894"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}