AAMI 15223 1 2016
$93.55
ANSI/AAMI/ISO 15223-1:2016 – Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 38 |
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 15223-1:2016; Medical Devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 8 | Background of ANSI/AAMI/ISO 15223-1 |
| 9 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 14 | 4 General requirements 4.1 Proposal of symbols for adoption 4.2 Requirements for usage |
| 15 | 4.3 Other symbols 5 Symbols |
| 16 | Table 1 — Symbols to convey information essential for proper use |
| 33 | Annex A (informative) Examples A.1 Example of use of symbol 5.1.1, “Manufacturer” A.2 Example of use of symbol 5.1.1, “Manufacturer”, combined with 5.1.3, “Date of manufacture” A.3 Example of use of symbol 5.1.2, “Authorized representative in the European Community” A.4 Examples of use of symbol 5.1.3, “Date of manufacture” |
| 34 | A.5 Examples of use of symbol 5.1.4, “Use-by date” A.6 Example of use of symbol 5.1.5, “Batch code” A.7 Example of use of symbol 5.1.6, “Catalogue number” A.8 Example of use of symbol 5.1.7, “Serial number” A.9 Examples of use of symbols for “Sterile fluid path” |
| 35 | A.10 Examples of use of symbols for temperature limits A.11 Examples of use of symbol 5.3.8, “Humidity limitation” A.12 Example of use of symbol 5.3.9, “Atmospheric pressure limitation” |
| 36 | A.13 Examples of use of symbol 5.5.5, “Contains sufficient for tests” A.14 Example of use of symbol 5.7.1, “Patient number” A.15 Example of use of symbol 5.4.3, “Consult instructions for use” for an electronic instruction for use (eIFU) |
| 37 | Annex B (informative) Use of general prohibition symbol and negation symbol B.1 General prohibition symbol B.2 Negation symbol |
| 38 | Bibliography |
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