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Norm
ÖNORM EN ISO 15225
Issue date: 2005 09 01
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000 + A1:2004) (consolidated version)
This European Standard specifies requirements and guidance for the construction of a
nomenclature for medical devices in order to facilitate co-operation and exchange of...
Withdrawn: 2010 08 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 26 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
This European Standard specifies requirements and guidance for the construction of a
nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory
data on an international level between interested parties such as: Regulatory Authorities,
Manufacturers, Suppliers, Health Care Providers, and End Users.
NOTE 1: This European Standard includes guidelines for a minimum data set and its
structure. These guidelines are provided for system designers setting up databases
utilizing the nomenclature system described herein.
The requirements contained in this standard are applicable to the development and maintenance
of a European nomenclature for medical device identification.
NOTE 2: This European Standard will not include the nomenclature itself. The
nomenclature will be supplied as a separate document.
NOTE 3: It is intended to complement the specific requirements of the EC Directives
on medical devices in the context of specifying means by which common
identification can be achieved between bodies required to exchange data in conformity
with the requirements of the Directives.
ÖVE/ÖNORM EN ISO 15225
2016 12 15
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
Norm
ÖNORM EN ISO 15225
2010 08 01
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
Norm
ÖNORM EN ISO 15225
2005 09 01
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regula...
Norm
↖
ÖNORM EN ISO 15225
2004 05 01
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regula...
Norm
ÖNORM EN ISO 15225
2000 07 01
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regula...
Norm
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1998 04 16
Information technology — 8-bit single-byte coded graphic character sets — Part 1: Latin alphabet No. 1
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1987 07 02
Information processing systems — Vocabulary — Part 4: Organization of data
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Issue date :
1996 05 30
Information technology — Vocabulary — Part 17: Databases
Norm
Issue date :
2010 08 01
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
Norm
Issue date :
2000 09 07
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange