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CEN/TR 15133:2005

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Nomenclature - Collective terms and codes for groups of medical devices
Withdrawn date

01-17-2024

Published date

06-15-2005

Foreword
Introduction
1 Scope
2 Lists of collective terms
  2.1 Application of Common Technology
  2.2 Using similar manufacturing procedures
  2.3 For similar medical procedures
  2.4 Using common materials
  2.5 Specific risk-associated considerations
Bibliography

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
CEN/CLC/JTC 3
DocumentType
Technical Report
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

I.S. EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
06/30123163 DC : 0 BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES
I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
CEI UNI EN 1041 : 2014 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
DIN EN 1041:2013-12 Information supplied by the manufacturer of medical devices (includes Amendment A1:2013)
15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
UNE-EN 16372:2015 Aesthetic surgery services
I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
UNI CEI EN 1041 : 2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
UNE-EN 1041:2009 Information supplied by the manufacturer of medical devices
BS EN 1041 : 2008 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
EN 16372:2014 Aesthetic surgery services
BS EN 16372:2014 Aesthetic surgery services
08/30159296 DC : DRAFT APR 2008 BS EN ISO 15225 - NOMENCLATURE - SPECIFICATION FOR A NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE
BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
ONORM EN 1041 : 2013 INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES

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

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