Nomenclature. Collective terms and codes for groups of medical devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-12-2005

Publisher

British Standards Institution

This Technical Report lists collective terms and codes for groups of medical devices having common features. The listing is structured so that the terms can be used for the purposes required in regulatory reporting and for communication relevant to the application of the medical device regulation.

For certain purposes in the application of the Medical Devices Directives, there is an urgent need for the development of a list of collective terms based on the identified principles to be used, for examples, as follows:

to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families or types of medical devices are covered within a manufacturer\'s quality system,
to be used to identify the range of skills and general technological abilities for which a Notified Body has been approved, and is so appointed by the relevant Competent Authority,
for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED).

For the purpose of developing sets of collective terms, Accessories to medical devices are integrated de facto in the corresponding medical device collective term.

Committee	CH/210/3
DocumentType	Standard
Pages	18
PublisherName	British Standards Institution
Status	Current

Standards	Relationship
CEN/TR 15133:2005	Identical

CR 14230 : 2001	GLOBAL MEDICAL DEVICE NOMENCLATURE FOR THE PURPOSE OF REGULATORY DATA EXCHANGE
EN ISO 15225:2016	Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
ISO 15225:2016	Medical devices Quality management Medical device nomenclature data structure
ISO/TS 20225:2001	Global medical device nomenclature for the purpose of regulatory data exchange