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AAMI 15223 1 2022

AAMI 15223 1 2022

$143.79

ANSI/AAMI/ISO 15223-1:2022, Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1: General requirements

Published By Publication Date Number of Pages
AAMI 2022 44
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Specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements. These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 15223-1:2022; Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1: General requirements
4 AAMI Standard
5 Copyright information
Contents Page
6 Committee representation
7 Background of ANSI/AAMI adoption of ISO 15223-1:2021
8 Foreword
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
17 4 General requirements
4.1 Future symbols
4.2 Requirements for usage
4.3 Other symbols
5 Symbols
18 Table 1—Symbols to convey medical device information
36 Annex A (informative) Guidance and examples of symbol use, including multiple symbols
A.1 Guidance
A.2 Examples of use of symbol 5.1.1, “Manufacturer”
A.3 Examples of use of symbol 5.1.1, “Manufacturer”, combined with 5.1.3, “Date of manufacture”
A.4 Example of use of symbol 5.1.2, “Authorized representative in the European Community/European Union”
37 A.5 Examples of use of symbol 5.1.3, “Date of manufacture”
A.6 Examples of use of symbol 5.1.4, “Use-by date”
A.7 Examples of use of symbol 5.1.5, “Batch code”
A.8 Examples of use of symbol 5.1.6, “Catalogue number”
A.9 Examples of use of symbol 5.1.7, “Serial number”
A.10 Examples of use of symbol 5.1.8, “Importer”
38 A.11 Examples of use of symbol 5.1.9, “Distributor”
A.12 Examples of use of symbol 5.1.11, “Country of manufacture”
A.13 Examples of use of symbol 5.2.9 for “Sterile fluid path”
39 A.14 Examples of use of symbol 5.3.8, “Humidity limitation”
A.15 Example of use of symbol 5.3.9, “Atmospheric pressure limitation”
A.16 Example of use of symbol 5.4.3, “Consult instructions for use or consult electronic instructions for use” for an electronic instruction for use (eIFU)
A.17 Examples of use of symbol 5.5.5, “Contains sufficient for tests”
A.18 Example of use of symbol 5.7.1, “Patient number”
40 A.19 Examples of use of symbol 5.7.8, “Translation”
A.20 Examples of use of symbol 5.7.9, “Repackaging”
A.21 Examples of use of symbol 5.7.10, “Unique device identifier”
A.22 Examples of use of symbols 5.2.11 to 5.2.14 in conjunction with symbols 5.2.1 to 5.2.5, 5.2.9 or 5.2.10
A.23 Explanation on how to deal with multiple symbols used together
42 Annex B (informative) Use of general prohibition symbol and negation symbol
B.1 General prohibition symbol
B.2 Negation symbol
43 Bibliography

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AAMI 15223 1 2022
$143.79