M/321 - Sub-categories for medical dev

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.

IEC 60269-2:2013 provides supplementary requirements for fuses for use by authorized persons and are generally designed to be used in installations where the fuse-links are accessible to, and may be replaced by, authorized persons only. Fuses for use by authorized persons according to the following fuse systems also comply with the requirements of the corresponding subclauses of IEC 60269-1, unless otherwise defined in this standard. This standard is divided into fuse systems, each dealing with a specific example of standardized fuses for use by authorized persons: - Fuse system A: Fuses with fuse-links with blade contacts (NH fuse system), - Fuse system B: Fuses with striker fuse-links with blade contacts (NH fuse system), - Fuse system C: Fuse-rails (NH fuse system), - Fuse system D: Fuse-bases for busbar mounting (NH fuse system), - Fuse system E: Fuses with fuse-links for bolted connections (BS bolted fuse system), - Fuse system F: Fuses with fuse-links having cylindrical contact caps (NF cylindrical fuse system), - Fuse system G: Fuses with fuse-links with offset blade contacts (BS clip-in fuse system), - Fuse system H: Fuses with fuse-links having 'gD' and 'gN' characteristic (class J and class time delay and non time delay fuse types), - Fuse system I: gU fuse-links with wedge tightening contacts, - Fuse system J: Fuses with fuse-links having 'gD class CC' and 'gN class CC' characteristics (class CC time delay and non-time delay fuse types), - Fuse system K: gK fuse-links with blade for bolted connections - High fuse-link ratings from 1 250 A up to 4 800 A (master fuse-links). This fifth edition of IEC 60269-2 cancels and replaces the fourth edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: 1. fuse systems A and B: modified values for the power dissipation of NH aM fuse-links; 2. fuse systems A and B: introduction of dimension r for NH fuse-links; 3. addition of new fuse system K: gK fuse-links with contacts for bolted connections. Key Words: fuse systems A to K, requirements for fuses