AAMI 15223 2 2010 RA 2016
$93.55
ANSI/AAMI/ISO 15223-2:2010/(R)2016 – Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 2: Symbol development, selection and validation
| Published By | Publication Date | Number of Pages |
| AAMI | 2010 | 29 |
This part of ISO 15223 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 15223-2:2010, Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied—Part 2: Symbol development, selection and validation |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of ANSI/AAMI adoption of ISO 15223-2:2010 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 15 | 4 Principles for identification and development of new symbols 4.1 Identifying the need for a symbol 4.2 Symbols with horizontal applications 4.3 Symbols for use within a restricted range of device types 5 Process for selecting and validating symbols for inclusion in ISO 15223-1 5.1 General |
| 16 | 5.2 Initial evaluation 5.3 Second evaluation |
| 20 | 6 Classification of risk 7 Concept development 7.1 Existence of other symbols |
| 21 | 7.2 Symbol design 8 Evaluation 8.1 Testing early symbol concepts |
| 22 | 8.2 Comprehension testing 8.3 Memory testing 8.4 Usability testing |
| 23 | 9 Acceptance criteria 9.1 General 9.2 Symbols with no to low safety relevance 9.3 Symbols with moderate to high safety relevance |
| 24 | Annex A Information to be provided during the symbol development processfor adoption of a symbol into ISO 15223-1 |
| 25 | Annex B ISO/TC 145/SC 3 proposal for graphical symbols B.1 ISO/TC 145/SC 3 symbol proposal form |
| 26 | B.2 Basic pattern for symbol design B.3 ISO/TC 145/SC 3 registration process steps |
| 27 | Annex C IEC/SC 3C proposal for graphical symbol form |
| 29 | Bibliography |
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