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YY/T 0466.2-2015Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation

医疗器械 用于医疗器械标签、标记和提供信息的符号 第2部分:符号的制订、选择和确认

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Issued by

CFDA

Level / Type

Industry · Recommended

Issue date

March 2, 2015

Implementation date

January 1, 2016

Scope

YY/T 0466.2-2015 is the English-translated version of 医疗器械 用于医疗器械标签、标记和提供信息的符号 第2部分:符号的制订、选择和确认.

This part of YY/T 0466 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. Its purpose is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in this part has been complied with, then the residual risks (as defined in ISO 14971 and IEC 62366) associated with the usability of the symbol are reduced. Identical adoption of ISO 15223-2:2010.

Table of Contents

  1. 1.Foreword
  2. 2.Introduction
  3. 3.1 Scope
  4. 4.2 Normative references
  5. 5.3 Terms and definitions
  6. 6.4 Principles for identification and development of new symbols
  7. 7.5 Symbol validation
  8. 8.Annex A
  9. 9.Annex B
  10. 10.Bibliography

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