YY/T 0466.1-2009 (YYT 0466.1-2009)

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Related Standard	Status	PDF
YY/T 0466.1-2009	English	699	Add to Cart	3 days	Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements	YY/T 0466.1-2009	Obsolete	YY/T 0466.1-2009

YY/T 0466.1-2009
Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied.Part 1. General requirements
ICS 01.080.20; 11.040.01
C37
People's Republic of China pharmaceutical industry standards
YY/T 0466.1-2009/ISO 15223-1.2007
Partially replaced YY 0466-2003
Medical equipment used with medical device labels,
Signs and symbols provide information
Part 1. General requirements
(ISO 15223-1.2007, IDT)
Posted 2009-11-25
2010-12-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 2 General requirements
4.1 Proposal 2 uses symbols
4.2 requirements 2
5 Symbol 3
Appendix A (informative) Example 8
Appendix B (normative) proposed using 10 symbols in YY/T 0466.1 in
Basic Mode Appendix C (normative) Symbol Design 11
Appendix D (informative) General prohibition sign 12
References 13
YY/T 0466.1-2009/ISO 15223-1.2007
Foreword
YY/T 0466 "medical devices for medical device labels, labeling and information symbols" is divided into two parts.
--- Part 1. General requirements;
--- Part 2. Symbol development, selection and confirmation.
This section YY/T Section 10466 of.
This part identical with ISO 15223-1.2007 "medical devices for medical device labels, labeling and information symbols 1
Part I. General requirements "(in English).
This section is being drafted and in Part 2 of the common place of the standard YY 0466-2003. Compared with YY 0466-2003, the main technical
Surgery changes are as follows.
--- YY 0466-2003 for the safe and effective use of medical devices, to users and other personnel provisions for providing important letter
Interest symbols. This standard is a revised version of this section to determine the expression system for medical devices safe and effective use of information symbols
Fixed and usage requirements, but also meet the requirements of this section lists the symbols.
--- Part 2 to Part 1 included the development, selection and confirmation process prescribed symbols, its purpose is to ensure that Part 1
Symbol contained readily understood by the target group.
This section of the Appendix A and Appendix D is an informative annex, Annex B and Annex C is normative appendix.
This part is proposed by the State Food and Drug Administration Medical Device Division.
This part of the National Standardization Technical Committee on Medical Device Quality Management and General Requirements (SAC/TC221) centralized.
This section is drafted. Medical Device Quality Management and Standardization Technical Committee general requirements, limited Beijing Hua Yi Xie Certification
the company.
The main drafters of this section. Wu Junhua, Chen Zhigang, Milan English, Qin Shuhua WORKER.
This Part replaces. YY 0466-2003.
YY/T 0466.1-2009/ISO 15223-1.2007
introduction
YY/T 0466 made a number of symbols used to convey information to the regulatory body that the projects these symbols and safety for medical devices
Fair use is very important. Thus, the scope of many regulations require these symbols and instruments appear together. This information may be required in the instrument
On the label as part of, or together with the equipment provided. Many countries require medical instruments represent information in their own language, which gives the instrument
Manufacturers and users increases the problem.
Manufacturers try to reduce costs by simplifying the mark or reasonable changes. When a single label or part of the file contains multiple languages
, It will cause problems translation, design and logistics. Medical Device User for many different languages on the label will be confused, and
Delays in determining the appropriate language. YY/T 0466 by using a clearly defined meaning of the solution internationally recognized symbols, raised these issues
Summary program.
When editing YY/T 0466 in symbols, ISO /T C210 aware of the development needs and proposals symbol system uses a method expression,
This will be the YY/T 0466 Part 2 theme