YY/T 0468-2015Medical devices—Quality management—Medical device nomenclature data structure (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

Instead of the standard YY/T 0468-2003 "named for managing information exchange medical device nomenclature system specification." versus

YY/T 0468-2003 compared to, in addition to major technical changes in the detailed introduction, for the accurate expression of meaning, also revised the following terms.

--- "Device Category" to "Device Category";

--- "Device Type" to "Device Type";

--- "External key" to "foreign key";

--- "Like instrument group" is changed to "similar instrument";

--- "Named" to "terminology";

--- "Master key" to "primary key";

--- "Associated structures" to "relational structure";

--- "Second key" to "secondary key";

--- "Synonymous" to "synonymous";

--- "Attribute the term" change "template term." This standard uses the translation method identical with ISO 15225:2010 "medical device quality management system terminology medical device data structure".

Introduction

This standard is expected to contribute to the regulatory bodies, conformity assessment bodies, health care institutions and manufacturers to submit and exchange information. The standard is designed to enable Information quasi coverage available in the public domain.

The second edition of this standard is based on the experience gained in the first version of the application is based and prepared. The following is the first edition made major change.

--- In Chapter 3 adds definition. basic concepts, terminology collections, equipment category, equipment type, similar equipment, global medical device operation Language System (GMDN), GMDN agency, multiple correlation synonyms, product specifier and template specifiers;

--- Increase in Appendix A code 13, 14 and 15, and to the example of a new technology description was updated;

--- Increasing the appendix contains a collection of examples of the term D.

This standard contains requirements applicable to the development and updating of international terminology system, specifically for its global medical device terminology (GMDN) structure developed.

1 Scope

The standard term for the medical device system data structure provides rules and guidelines in order to facilitate data used by regulatory agencies in the international Exchanges and cooperation between the parties concerned (for example, regulators, manufacturers, suppliers, health care institutions and end users) within the range.

This standard includes guidelines and minimum data set structure. These guidelines are provided to enable system designers to take advantage of the terms described herein Establishment of a database system.

This standard contains requirements that can be used to establish and maintain international terminology medical device identification.

This standard does not include the term system as a data file provided by itself.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

ISO /IEC 8859-1:1998 Information technology - 8-bit single-byte coded graphic character sets - Part 1. Latin alphabet No. 1 (Infor-mationtechnology-8-bitsingle-bytecodedgraphiccharactersets-Part 1. LatinalphabetNo.1)

3 Terms and Definitions

The following terms and definitions apply to this document 1).

1) of this standard, many of the terms used are based on regulations, such as "medical devices", "custom medical devices" and "manufacturer." These patients Language is defined in terms of their respective jurisdictions system use.