HOME   Cart(3)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY/T 0468-2015 English PDF

US$879.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0468-2015: Medical devices. Quality management. Medical device nomenclature data structure
Status: Obsolete

YY/T 0468: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0468-2015English879 Add to Cart 4 days [Need to translate] Medical devices. Quality management. Medical device nomenclature data structure Obsolete YY/T 0468-2015
YY/T 0468-2003English719 Add to Cart 3 days [Need to translate] Nomenclature-Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange Obsolete YY/T 0468-2003

PDF similar to YY/T 0468-2015


Standard similar to YY/T 0468-2015

YY/T 0466.1   YY/T 0466.2   YY/T 0191   

Basic data

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 22,261
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Older Standard (superseded by this standard) YY/T 0468-2003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
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies) State 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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical devices.Quality management.Medical device nomenclature data structure ICS 11.040.01; 35.240.80 C37 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

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". 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.

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. 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. 3.1 Basic Concepts baseconcept The most general expression of similar equipment, is the main basis for the list of GMDN. [GMDN agency] 3.2 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] 3.3 Code code Systems and represent letters, alphanumeric or numeric characters, communication, or on behalf of both the rules and communicate information. 3.4 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.

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0468-2015_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0468-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0468-2015_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0468-2015_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY/T 0468-2015?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0468-2015 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.