ANSI AAMI ISO 15225-2016 pdf download
ANSI AAMI ISO 15225-2016 pdf download.Medical devices—Quality management—Medical device nomenclature structire
4.2.1 Description
A term describes a generic device group of medical devices, i.e. a set of devices having the same or similar intended use(s) and commonality of technology. Sets of devices are grouped together (as a generic device group) for the purpose of device vigilance reporting, or other purposes where sets of essentially similar devices from different sources need to be collected. Potentially, any device attribute (e.g. implant/non-implant, sterile/non-sterile) can be used as a means of arranging associated data. A term is the only method used for product identification. A term shall be unambiguous and unique and comprise the following elements:
4.2.2 Term name
The term name shall be a short unique descriptor which unambiguously describes the device group. It shall be in the form of a single or compound noun, possibly with familiar adjectives, that is as close to natural language as is practically possible. One or more qualifiers considered to be important distinguishing features, e.g. single- use/reusable, sterile/non-sterile, can be added and preceded by a comma. EXAMPLE General-purpose surgical drape, single-use, sterile. Ambiguous phrases such as “sundries”, “others”, “appliances”, “miscellaneous” and “various” should not be used. Trade names shall not be used in term names.
4.2.3 Term definition
Terms shall be assigned a definition of not more than 700 characters in the English Language version which defines the scope of the term name, i.e. the devices that are included in the generic device group. It should include statements about the intended clinical application, the technology used and important attributes. Definitions shall be worded in such a way that users will understand and be familiar with the content, so that it is clear whether a particular device type is covered by the term.
4.2.4 Term code
A five-character numeric code shall be assigned systematically to each term, to be used as the digital identifier. The identifier will be unique and be attached to the same entity for the full life cycle of the term.
4.2.5 Links to relevant collective term(s) (see 4.3)
Within the database, relationships shall be established between the term and all the collective terms that are relevant, and that can be used to group devices at a higher level than the term. The relationship between terms and collective terms may necessarily be many-to-many. See 4.3.
4.3 Collective term
Collective terms may be terms used in the nomenclature for the following: a) grouping together terms with common characteristics, e.g. clinical application, common technology, materials, medical specialities, manufacturing processes; b) determining the range of skills and general technological abilities required for the assessment of a device. Collective terms shall link directly to terms. Collective terms shall also be linked to each other to form a multi- hierarchical structure. Collective terms may group several terms with common features. A collective term can be used to select a larger group of medical devices and also to analyse larger sets of data. The collective terms are arranged in a multi-hierarchy with individual parent-child cascades having a variable number of levels. The multi-hierarchical structure of collective terms supports the grouping of larger sets of terms. There are a number of top-level nodes (see Annex D) which represent important grouping attributes/properties/function. Terms are linked to a collective term at any level in a cascade and will be automatically linked to all the parents of that collective term. Terms can be linked to many collective terms in different parts of the tree structure. Collective terms shall not be used for the purpose of product identification.
