# Copyright Oughtibridge Ltd digraph "medical_device" { fontname="Cambria" # label="medical device" layout="fdp" size="8.8 12" # Keep within 8.8" wide, 12" deep sep=0.3 outputmode=edgefirst remincross=true splines=curved overlap=false node [shape=box style=rounded] # Defines the common node specification # Diagram specific parameters - override any above # Start of the main graph # List of concepts #medical device 35 [label="medical device" fontname="Cambria" URL="https://81001.org/concept/medical_device" tooltip="instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one of more of the specific medical purpose(s) of — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury, — investigation, replacement, modification, or support of the anatomy or of a physiological process, — supporting or sustaining life, — control of conception, — cleaning, disinfection, or sterilization of medical devices, — providing information by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means" color="#ff0700"] #integrator 28 [label="integrator" fontname="Cambria" URL="https://81001.org/concept/integrator" tooltip="role responsible for the incorporation of components into the health IT infrastructure used by the healthcare delivery organization, including technical installation, configuration, and data migration" color="#02f4ff"] #product 40 [label="product" fontname="Cambria" URL="https://81001.org/concept/product" tooltip="output of an organization that can be produced without any transaction taking place between the organization and the customer" color="#ff0700"] #product 40 [label="product" fontname="Cambria" URL="https://81001.org/concept/product" tooltip="output of an organization that can be produced without any transaction taking place between the organization and the customer" color="#ff0700"] #assurance case 4 [label="assurance case" fontname="Cambria" URL="https://81001.org/concept/assurance_case" tooltip="reasoned, auditable artefact created that supports the contention that its top-level claim (or set of claims), is satisfied, including systematic argumentation and its underlying evidence and explicit assumptions that support the claim(s)" color="#a7ff00"] #assurance case 4 [label="assurance case" fontname="Cambria" URL="https://81001.org/concept/assurance_case" tooltip="reasoned, auditable artefact created that supports the contention that its top-level claim (or set of claims), is satisfied, including systematic argumentation and its underlying evidence and explicit assumptions that support the claim(s)" color="#a7ff00"] #healthcare delivery organization 25 [label="healthcare delivery organization" fontname="Cambria" URL="https://81001.org/concept/healthcare_delivery_organization" tooltip="facility or enterprise such as a clinic or hospital that provides healthcare services" color="#02f4ff"] #manufacturer 34 [label="manufacturer" fontname="Cambria" URL="https://81001.org/concept/manufacturer" tooltip="organization with responsibility for design or manufacture of a product" color="#02f4ff"] #manufacturer 34 [label="manufacturer" fontname="Cambria" URL="https://81001.org/concept/manufacturer" tooltip="organization with responsibility for design or manufacture of a product" color="#02f4ff"] #intended use 29 [label="intended use" fontname="Cambria" URL="https://81001.org/concept/intended_use" tooltip="use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer" color="#a74d00"] #life cycle 33 [label="life cycle" fontname="Cambria" URL="https://81001.org/concept/life_cycle" tooltip="series of all phases in the life of a product or system, from the initial conception to final decommissioning and disposal" color="#ff0700"] #manufacturer 34 [label="manufacturer" fontname="Cambria" URL="https://81001.org/concept/manufacturer" tooltip="organization with responsibility for design or manufacture of a product" color="#02f4ff"] #responsibility agreement 44 [label="responsibility agreement" fontname="Cambria" URL="https://81001.org/concept/responsibility_agreement" tooltip="document that fully defines the responsibilities of all relevant stakeholders" color="#02f4ff"] #quality 41 [label="quality" fontname="Cambria" URL="https://81001.org/concept/quality" tooltip="degree to which all the properties and characteristics of a product, process, or service satisfy the requirements which ensue from the purpose for which that product, process, or service is to be used" color="#a74d00"] #reasonably foreseeable misuse 76 [label="reasonably foreseeable misuse" fontname="Cambria" URL="https://81001.org/concept/reasonably_foreseeable_misuse" tooltip="use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour" color="#a7ff00"] #asset 3 [label="asset" fontname="Cambria" URL="https://81001.org/concept/asset" tooltip="physical or digital entity that has value to an individual, an organization or a government" color="#ff0700"] #asset 3 [label="asset" fontname="Cambria" URL="https://81001.org/concept/asset" tooltip="physical or digital entity that has value to an individual, an organization or a government" color="#ff0700"] #component 9 [label="component" fontname="Cambria" URL="https://81001.org/concept/component" tooltip="collection of system resources that (a) forms a physical or logical part of the system, (b) has specified functions and interfaces, and (c) is treated (e.g., by policies or specifications) as existing independently of other parts of the system." color="#ff0700"] #harm 17 [label="harm" fontname="Cambria" URL="https://81001.org/concept/harm" tooltip="injury or damage to the health of people, or damage to property or the environment" color="#a7ff00"] #security capability 57 [label="security capability" fontname="Cambria" URL="https://81001.org/concept/security_capability" tooltip="broad category of technical, administrative or organizational controls to manage risks to confidentiality, integrity, availability and accountability of data and systems" color="#a74d00"] #health IT infrastructure 21 [label="health IT infrastructure" fontname="Cambria" URL="https://81001.org/concept/health_IT_infrastructure" tooltip="combined set of IT assets available to the individual or organization for developing, configuring, integrating, maintaining, and using IT services and supporting health, patient care and other organizational objectives" color="#ff0700"] #List of generalisations and specialisations #product IS A asset 3 -> 40 [arrowtail="onormal" dir="back" color="blue" label="" tooltip="product is a type of asset" fontname="Cambria"] #assurance case IS A product 40 -> 4 [arrowtail="onormal" dir="back" color="blue" label="" tooltip="assurance case is a type of product" fontname="Cambria"] #component IS A product 40 -> 9 [arrowtail="onormal" dir="back" color="blue" label="" tooltip="component is a type of product" fontname="Cambria"] #medical device IS A product 40 -> 35 [arrowtail="onormal" dir="back" color="blue" label="" tooltip="medical device is a type of product" fontname="Cambria"] # List of associations #1 asset has part 0..* component 3 -> 9 [constraint=false, dir="forward" label="has part" fontname="Cambria"] #0..* assurance case evidences safety of 1..* product 4 -> 40 [constraint=false, dir="forward" label="evidences safety of" fontname="Cambria"] #0..* assurance case evidences security of 1..* product 4 -> 40 [constraint=false, dir="forward" label="evidences security of" fontname="Cambria"] #0..* harm damages 0..* asset 17 -> 3 [constraint=false, dir="forward" label="damages" fontname="Cambria"] #0..* healthcare delivery organization uses 0..* product 25 -> 40 [constraint=false, dir="forward" label="uses" fontname="Cambria"] #1..* intended use is defined by 1 manufacturer 29 -> 34 [constraint=false, dir="forward" label="is defined by" fontname="Cambria"] #1 manufacturer agrees 0..* responsibility agreement 34 -> 44 [constraint=false, dir="forward" label="agrees" fontname="Cambria"] #1 manufacturer has accountability for design and manufacture of 1..* product 34 -> 40 [constraint=false, dir="forward" label="has accountability for design and manufacture of" fontname="Cambria"] #1 manufacturer manufactures 0..* product 34 -> 40 [constraint=false, dir="forward" label="manufactures" fontname="Cambria"] #0..* product has 1..* intended use 40 -> 29 [constraint=false, dir="forward" label="has" fontname="Cambria"] #1 product has 1 life cycle 40 -> 33 [constraint=false, dir="forward" label="has" fontname="Cambria"] #0..* product produced by 0..* manufacturer 40 -> 34 [constraint=false, dir="forward" label="produced by" fontname="Cambria"] #1 quality measures alignment with 1 intended use 41 -> 29 [constraint=false, dir="forward" label="measures alignment with" fontname="Cambria"] #0..1 responsibility agreement concerns 1..* product 44 -> 40 [constraint=false, dir="forward" label="concerns" fontname="Cambria"] #0..* security capability manage security risk to 0..* asset 57 -> 3 [constraint=false, dir="forward" label="manage security risk to" fontname="Cambria"] #0..* product has 1 quality 40 -> 41 [constraint=false, dir="forward" label="has" fontname="Cambria"] #1..* integrator integrates 0..* medical device 28 -> 35 [constraint=false, dir="forward" label="integrates" fontname="Cambria"] #1 healthcare delivery organization assigns responsibility to 1..* integrator 25 -> 28 [constraint=false, dir="forward" label="assigns responsibility to" fontname="Cambria"] #0..* health IT infrastructure comprises 1..* asset 21 -> 3 [constraint=false, dir="forward" label="comprises" fontname="Cambria"] #0..* manufacturer does not intend 0..* reasonably foreseeable misuse 34 -> 76 [constraint=false, dir="forward" label="does not intend" fontname="Cambria"] #0..* reasonably foreseeable misuse applies to 0..* product 76 -> 40 [constraint=false, dir="forward" label="applies to " fontname="Cambria"] }

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