MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build
MedTechLabel WP2 T1.1 Information Model Guide
0.4.3 - ci-build
MedTechLabel WP2 T1.1 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/medtechlabel-wp2-im/ and changes regularly. See the Directory of published versions
A list of terms may help to understand the information provided in this guide:
| Term | Synonym | Definition | originating standard |
|---|---|---|---|
| accessory | item intended specifically by its manufacturer to be used together with one or more medical devices (3.23) to specifically enable or assist those medical devices to be used in accordance with their intended use | ISO 20417 | |
| accompanying information | information supplied by the manufacturer (3.15) with or marked (3.22) on a medical device (3.23) or accessory (3.1) for the user (3.49) or responsible organization (3.33), particularly regarding safe use | ISO 20417 | |
| applicable policy | set of requirements relating to a product and its attributes such as form, fit, function, process or information supplied by the manufacturer (3.15) | ISO 20417 | |
| authority having jurisdiction | governmental agency or office assigned to oversee the regulation of a regulated product within a country, jurisdiction or assigned territory | ISO 20417 | |
| authorized representative | organization (3.28) established within a country or jurisdiction who has received a written mandate from the manufacturer to act on their behalf for specified tasks regarding the latter’s obligations under that country or jurisdiction’s legislation | ISO 20417 | |
| catalogue number, commercial product name, commercial product code | reference number, reorder number | value given by the manufacturer to identify a specific medical device (3.23) or accessory (3.1) as it relates to its form, fit, function and process | ISO 20147 |
| clearly legible | easily legible | capable of being read by a person with normal vision | ISO 20147 |
| distributor | organization (3.28), different from the manufacturer or importer (3.13), in the supply chain who, on their own behalf, furthers the availability of a product to the user (3.49) | ISO 20147 | |
| e-documentation | electronic documentation | form of electronically accessible information supplied by the manufacturer (3.15) | ISO 20147 |
| essential principles | essential principles of safety and performance | fundamental high-level requirements that, when conformed with, ensure a medical device (3.23) or accessory (3.1) is safe and performs as intended | ISO 20417 |
| expected lifetime | expected service life | period specified by the manufacturer during which the product is expected to remain safe and effective for use | ISO 20417 |
| group standard | basic standard that specifies safety and performance criteria applicable to several or a family of similar products, processes, or services | ISO 20417 | |
| importer | organization (3.28) who imports a product that was manufactured in one locale into another locale for the purposes of marketing | ISO 20417 | |
| information for safety | information provided to the user (3.49) or responsible organization (3.33) as a risk control measure | ISO 20417 | |
| information supplied by the manufacturer | information related to the identification and use of a medical device (3.23) or accessory (3.1), in whatever form provided, intended to ensure the safe and effective use of the medical device or accessory | ISO 20417 | |
| instructions for use/ IFU | package insert | portion of the accompanying information (3.2) that is | ISO 20417 |
| IVD medical device | in vitro medical device | medical device (3.23), whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the patient (3.29) solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles | ISO 20417 |
| label | <medical device, accessory> written, printed, or graphic information appearing on the item itself, on the packaging of each item or on the packaging of multiple item | ISO 20417 | |
| labeling | |||
| lay | lay person | not having formal education in a relevant field of healthcare or medical discipline and, if appropriate, not having relevant specialized training on the use of the specific medical device (3.23) | ISO 20417 |
| lot | batch | defined amount of material or a defined number of medical devices (3.23), including finished product and accessories (3.1), that is manufactured in one process or a series of related processes and is intended to be homogenous | ISO 20417 |
| lot number + code | batch code + number | production control identifier containing a combination of letters or numbers associated with a single lot (3.20) | ISO 20417 |
| marking | information, in text or graphical format, durably affixed, printed, etched or attached by equivalent means to a product | ISO 20417 | |
| medical device | 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 patients (3.29), for one or 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,) ( disinfection of medical devices,) ( providing information by means of in vitro examination of specimens derived from the patient,) and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the patient, but which can be assisted in its intended function by such means | ISO 20147 | |
| medical device family | group of medical devices (3.23) manufactured by or for the same organization (3.28) and having the same basic design and performance characteristics related to safety, intended use and function | ISO 20417 | |
| model number | model | letters, numbers or a combination of these assigned by a manufacturer to distinguish, by function or type, a particular medical device (3.23),accessory (3.1) or medical device family (3.24) from another | ISO 20417 |
| multiple patient multiple use | <medical device, accessory> intended by the manufacturer to be reused on multiple patients (3.29) for multiple uses | ISO 20417 | |
| normal use | operation, including stand-by, routine inspection and adjustments by any user (3.49), in accordance with the accompanying information (3.2) or, for those products provided without accompanying information, with generally accepted practice | ISO 20417 | |
| organization | person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives | ISO 20417 | |
| patient | subject of care | living being receiving healthcare services | ISO 20417 |
| pictogram | simplified pictorial representation | ISO 20417 | |
| processing | <preparation of a healthcare product> processes to prepare a new or used healthcare product for its intended use | ISO 20417 | |
| product standard | standard that specifies necessary safety and performance requirements for a specific or a family of product(s), process(es), or service(s) making reference, as far as possible, to basic standards and group standards (3.12) | ISO 20417 | |
| responsible organization | organization (3.28) accountable for the installation, use, processing (3.31), maintenance, decommissioning or disposal of a medical device (3.23), accessory (3.1) and their detachable parts | ISO 20417 | |
| safety sign | sign giving a general safety message, obtained by a combination of a colour and geometric shape and which, by the addition of a symbol (3.42), gives a particular safety message | ISO 20417 | |
| serial number | production control identifier containing a combination of letters or numbers, selected by the manufacturer, intended for quality control and identification purposes to uniquely distinguish an individual product from other products with the same catalogue number (3.6) or model number (3.25) | ISO 20417 | |
| service personnel | organization (3.28) accountable to the responsible organization (3.33) for the installation assembly, maintenance or repair a medical device (3.23) or accessory (3.1) and their detachable parts | ISO 20417 | |
| shelf-life | period during which a product in its original packaging maintains its stability (3.40) under the conditions specified in the information supplied by the manufacturer (3.15) | ISO 20417 | |
| single patient multiple use | <medical device, accessory> intended by the manufacturer to be reused on an individual patient (3.29) for multiple uses | ISO 20417 | |
| single use, do not reuse | use only once | <medical device, accessory> intended by the manufacturer to be used on an individual patient (3.29) or an individual specimen during a single procedure and then disposed of | ISO 20417 |
| stability | <medical device, accessory> ability to maintain safety and performance characteristics within the specifications found in information supplied by the manufacturer (3.15) | ISO 20417 | |
| sterile | free from viable microorganisms | ISO 20417 | |
| symbol | graphical representation appearing on the label (3.18) or in accompanying information (3.2) of a product that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people | ISO 20417 | |
| technical description | portion of the accompanying information (3.2) | ISO 20417 | |
| UDI carrier, unique device identification carrier | means to convey the unique device identification (UDI) by using automatic identification and data capture (AIDC) and, if applicable, its human readable interpretation (HRI) | ISO 20417 | |
| usability | characteristic of the user (3.49) interface that facilitates use and thereby establishes use effectiveness, use efficiency and user satisfaction in the intended use environment (3.47) | ISO 20417 | |
| usability engineering | human factors engineering | application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of products and user (3.49) tasks to achieve adequate usability (3.45) | ISO 20417 |
| use environment | actual conditions and setting in which users (3.49) interact with a product | ISO 20417 | |
| use specification | description of the important characteristics related to the context of use of a product | ISO 20417 | |
| user | person operating, handling or interacting with the product | ISO 20417 |