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CEN/TR 15133

Nomenclature - Collective terms and codes for groups of medical devices

Số trang: 15
Ngày phát hành: 2005-06-00

Liên hệ
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.
Số hiệu tiêu chuẩn
CEN/TR 15133
Tên tiêu chuẩn
Nomenclature - Collective terms and codes for groups of medical devices
Ngày phát hành
2005-06-00
Trạng thái
Có hiệu lực
Tiêu chuẩn tương đương
PD CEN/TR 15133 (2005-12-12), IDT * DIN-Fachbericht CEN/TR 15133 (2005-09), IDT * ONR 2915133 (2006-01-01), IDT * UNI CEN/TR 15133:2005 (2005-11-17), IDT * DS/CEN/TR 15133 (2005-08-26), IDT * NPR-CEN/TR 15133:2005 en (2005-07-01), IDT
Tiêu chuẩn liên quan
Thay thế cho
prCEN/TR 15133 (2005-01)
Nomenclature - Collective terms and codes for groups of medical devices
Số hiệu tiêu chuẩn prCEN/TR 15133
Ngày phát hành 2005-01-00
Mục phân loại 01.040.11. Chăm sóc sức khỏe (Từ vựng)
11.040.01. Thiết bị y tế nói chung
Trạng thái Có hiệu lực
Thay thế bằng
Lịch sử ban hành
CEN/TR 15133 (2005-06)
Nomenclature - Collective terms and codes for groups of medical devices
Số hiệu tiêu chuẩn CEN/TR 15133
Ngày phát hành 2005-06-00
Mục phân loại 01.040.11. Chăm sóc sức khỏe (Từ vựng)
11.040.01. Thiết bị y tế nói chung
Trạng thái Có hiệu lực
* prCEN/TR 15133 (2005-01)
Nomenclature - Collective terms and codes for groups of medical devices
Số hiệu tiêu chuẩn prCEN/TR 15133
Ngày phát hành 2005-01-00
Mục phân loại 01.040.11. Chăm sóc sức khỏe (Từ vựng)
11.040.01. Thiết bị y tế nói chung
Trạng thái Có hiệu lực
Từ khóa
Categories * Class * Codes * Data exchange * Lists * Medical devices * Medical sciences * Medical technology * Nomenclature * Summary * Terminology * Terms * Vocabulary * Information exchange * Assembly * Medical products * Compilation
Số trang
15