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YY/T 0468-2015

Chinese Standard: 'YY/T 0468-2015'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0468-2015English339 Add to Cart Days<=4 Medical devices. Quality management. Medical device nomenclature data structure Valid YY/T 0468-2015
YY/T 0468-2015Chinese24 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]


Standard ID YY/T 0468-2015 (YY/T0468-2015)
Description (Translated English) Medical devices. Quality management. Medical device nomenclature data structure
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C37
Classification of International Standard 11.040.01; 35.240.80
Word Count Estimation 21,268
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
Older Standard (superseded by this standard) YY/T 0468-2003
Quoted Standard ISO/IEC 8859-1-1998
Adopted Standard ISO 15225-2010, IDT
Drafting Organization Beijing Hua Yi Xie Certification Co., Ltd.
Administrative Organization National Medical Device Quality Management and General Requirements Standardization Technical Committee
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Proposing organization China Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This Standard applies to medical devices terminology system data structures to facilitate data exchange used by regulatory agencies and the cooperation of all concerned (for example, regulators, manufacturers, suppliers, health care institutions and end-users) at the international level between. This Standard includes guidelines minimum data set and its structure. These guidelines are established to provide efficient database to enable system designers to use the term system described herein. This Standard contains requirements that can be used to establish and maintain international terminology recognition system for medical devices.

YY/T 0468-2015
Medical devices.Quality management.Medical device nomenclature data structure
ICS 11.040.01; 35.240.80
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0468-2003
Medical Device Quality Management
The term medical device system data structures
(ISO 15225.2010, IDT)
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions
Structural Principle 4 4
4.1 General 4
4.2 Device Category 4
4.3 collective term 4
Similar instruments 4.4 4
4.5 Device Type 5
4.6 The term system configuration Example 5
5 Requirements 6
5.1 Devices Category 6
5.2 Similar instruments 6
5.3 Device Type 8
5.4 collective term 8
6 8 data dictionary file
6.1 General 8
6.2 Devices category data file 8
6.3 8 similar instrument data files
6.4 instrument type data file 9
6.5 The term data collection file 10
Appendix A (informative) instrument category 11
Annex B (informative) instrument similar terms and synonyms build the sample 13
Annex C (informative) Example 15 similar recording device
Annex D (informative) Example 16 collective term
References 17
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
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the National Standardization Technical Committee on Medical Device Quality Management and General Requirements (SAC/TC221) centralized.
This standard was drafted. Beijing Hua Yi Xie Certification Co., Ltd..
The main drafters of this standard. Milan English, Xu Qiang, Han Zheng, Chen Zhigang.
This standard was first released in June 2003.
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
--- 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.
Medical Device Quality Management
The term medical device system data structures
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.
Basic Concepts baseconcept
The most general expression of similar equipment, is the main basis for the list of GMDN.
[GMDN agency]
Character character
Used to form, control, or a set of elements in the data element represents.
[ISO /IEC 8859-1.1998, the definition of 4.3]
Code code
Systems and represent letters, alphanumeric or numeric characters, communication, or on behalf of both the rules and communicate information.
Collective term colectiveterm
Describe many common characteristics or features term used for administrative or other purposes, including many of the same term instruments has been recognized.
Related standard:   YY/T 0466.1-2016  YY/T 0466.2-2015
Related PDF sample:   YY 0677-2008  YY 0678-2008
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