SIST EN 80001-1:2011

Oznaka standarda: SIST EN 80001-1:2011
Koda projekta: 22607
Organizacija: SIST
Naslov (angleški): Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 80001-1:2010)
Naslov (slovenski): Uporaba upravljanja tveganja za omrežja IT, ki vključujejo medicinske naprave - 1. del: Vloge, odgovornosti in dejavnosti (IEC 80001-1:2010)
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Tehnični odbor: IEMO - Električna oprema v medicinski praksi
ICS: 11.040.01 35.240.80
Status: Objavljen
Objavljen: 01-maj-2011
Refer. št. objave: Sporočila 2011-05
Področje projekta (angleško): Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEMSECURITY (the KEY PROPERTIES). This international standard does not specify acceptable RISK levels. NOTE 1 The RISK MANAGEMENT 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. This standard applies after a MEDICAL DEVICE has been acquired by a RESPONSIBLE ORGANIZATION and is a candidate for incorporation into an IT-NETWORK. NOTE 2 This standard does not cover pre-market RISK MANAGEMENT. This standard applies throughout the life cycle of IT-NETWORKS incorporating MEDICAL DEVICES. NOTE 3 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. This standard applies where there is no single MEDICAL DEVICE manufacturer assuming responsibility for addressing the KEY PROPERTIES of the IT-NETWORK incorporating a MEDICAL DEVICE. NOTE 4 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, the installation or assembly of the MEDICAL DEVICE according to the manufacturer’s ACCOMPANYING DOCUMENTS is not subject to the provisions of this standard regardless of who installs or assembles the MEDICAL DEVICE. NOTE 5 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, additions to that MEDICAL DEVICE or modification of the configuration of that MEDICAL DEVICE, other than as specified by the manufacturer, is subject to the provisions of this standard. This standard applies to RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and providers of other information technology for the purpose of RISK MANAGEMENT of an ITNETWORK incorporating MEDICAL DEVICES as specified by the RESPONSIBLE ORGANIZATION. This standard does not apply to personal use applications where the patient, OPERATOR and RESPONSIBLE ORGANIZATION are one and the same person. NOTE 6 In cases where a MEDICAL DEVICE is used at home under the supervision or instruction of the provider, that provider is deemed to be the RESPONSIBLE ORGANIZATION. Personal use where the patient acquires and uses a MEDICAL DEVICE without the supervision or instruction of a provider is out of scope of this standard. This standard does not address regulatory or legal requirements.
Področje projekta (slovensko): S spoznanjem, da MEDICINSKE NAPRAVE, ki so vgrajene v OMREŽJA IT, zato da se zagotovijo zaželene koristi (na primer MEDOBRATOVANJE), standard določa vloge, odgovornosti in dejavnosti, ki so potrebne za UPRAVLJANJE TVEGANJA OMREŽIJ IT, katere vsebujejo MEDICINSKE NAPRAVE za naslavljanje VARNOSTI, UČINKOVITOSTI ter PODATKOVNE IN SISTEMSKE VARNOSTI (KLJUČNE LASTNOSTI). Ta mednarodni standard ne določa sprejemljive stopnje TVEGANJA. OPOMBA 1: Dejavnosti UPRAVLJANJA TVEGANJ, opisane v tem standardu, so izpeljane iz tistih v ISO 14971 [4]. Razmerje med ISO 14971 in tem standardom je opisano v dodatku A. Ta standard velja, potem ko MEDICINSKO NAPRAVO pridobi ODGOVORNA ORGANIZACIJA in ko je kandidat za vgradnjo v OMREŽJE IT. OPOMBA 2: Ta standard ne zajema predtržnega OBVLADOVANJA TVEGANJ. Ta standard velja v življenjskem ciklusu OMREŽIJ IT, ki vsebujejo MEDICINSKE NAPRAVE. OPOMBA 3: Dejavnosti upravljanja življenjskega cikla, ki so opisane v tem standardu, so zelo podobne tistim v ISO/IEC 20000-2 [10]. Razmerje med ISO/IEC 20000-2 in tem standardom je opisano v dodatku D. Ta standard velja, kadar noben posamezni proizvajalec MEDICINSKIH NAPRAV ne prevzame odgovornosti za naslavljanje KLJUČNIH LASTNOSTIH OMREŽIJ IT, ki vsebujejo MEDICINSKO NAPRAVO. OPOMBA 4: Če en sam proizvajalec določa celotno MEDICINSKO NAPRAVO, ki vsebuje omrežje, potem vgradnja ali sestava MEDICINSKE NAPRAVE v skladu s proizvajalčevimi SPREMNIMI DOKUMENTI ni predmet določb tega standarda, ne glede na to, kdo vgradi ali sestavi MEDICINSKO NAPRAVO. OPOMBA 5: Če en sam proizvajalec določa celotno MEDICINSKO NAPRAVO, ki vsebuje omrežje, so dodatki k tej MEDICINSKI NAPRAVI ali spreminjanje konfiguracije MECINSKE NAPRAVE, ki so različni od nekaterih, ki jih določi proizvajalec, predmet določb tega standarda. Ta standard velja za ODGOVORNE ORGANIZACIJE, proizvajalce MEDICINSKIH NAPRAV in ponudnike drugih informacijskih tehnologij za namen OBVLADOVANJA TVEGANJ OMREŽJA IT, ki vsebuje MEDICINSKE NAPRAVE, kot določa ODGOVORNA ORGANIZACIJA. Ta standard ne velja za osebno uporabo, kjer so bolnik, OPERATER in ODGOVORNA ORGANIZACIJA ena in ista oseba. OPOMBA 6: Kadar se MEDICINSKA NAPRAVA uporablja doma pod nadzorom ali navodili ponudnika, se ponudnik šteje za ODGOVORNO ORGANIZACIJO. Osebna uporaba, ko bolnik pridobi in uporablja MEDICINSKO NAPRAVO brez nadzora ali navodil ponudnika, je zunaj področja uporabe tega standarda. Ta standard ne naslavlja regulativnih ali pravnih zahtev.

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