This International Standard provides rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, health care providers and end users. This International Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein.The requirements contained in this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification.This International Standard does not include the nomenclature itself, which is provided as a data file.
Số hiệu tiêu chuẩn
DS/EN ISO 15225
Tên tiêu chuẩn
Medical devices - Quality management - Medical device nomenclature data structure
Ngày phát hành
2010-08-19
Tiêu chuẩn tương đương
ISO 15225:2010, IDT * IDTEN ISO 15225:2010, IDT
Thay thế cho
DS/EN ISO 15225:2000 * DS/EN ISO 15225/A1:2004 * DS/EN ISO 15225/A2:2005
Lịch sử ban hành
DS/EN ISO 15225*DS/EN ISO 15225:2000*DS/EN ISO 15225/A1:2004*DS/EN ISO 15225/A2:2005
Từ khóa
CATEGORIES * CLASSIFICATION SYSTEMS * COMPUTER SCIENCES * DATA COMMUNICATION * DEFINITIONS * INFORMATION EXCHANGE * INFORMATION INTERCHANGE * INFORMATION SYSTEMS * IN-VITRO DIAGNOSTIC * MEDICAL DEVICES * MEDICAL PRODUCTS * MEDICAL SCIENCES * NOMENCLATURE * PRINCIPLE * PRODUCTS * PUBLIC HEALTH * SPECIFICATION (APPROVAL) * STRUCTURE * SYSTEMATICS * SYSTEMS * TECHNICAL LANGUAGES * TECHNICAL TERM * TEMPLATES * TERMINOLOGY * TERMS * VOCABULARY * DATA EXCHANGE * DEFINITION * TEXTURE * Categories * In-vitro diagnostic * Data exchange * Gauges * Texture * Information exchange * Nomenclature * Systems * Technical term * Data communication * Medical products * Classification systems * Specification (approval) * Vocabulary * Originals * Information interchange * Structure * Dates * Technical languages * Templates * Public health * Medical sciences * Systematics * Principle * Terminology * Definitions * Products * Training * Information systems * Computer sciences * Terms * Medical devices
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