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ANSI/AAMI/ISO 15223-1:2022, Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1: General requirements, 2022
- ANSI/AAMI/ISO 15223-1:2022; Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1: General requirements
- AAMI Standard
- Copyright information
- Contents Page
- Committee representation
- Background of ANSI/AAMI adoption of ISO 15223-1:2021
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements [Go to Page]
- 4.1 Future symbols
- 4.2 Requirements for usage
- 4.3 Other symbols
- 5 Symbols [Go to Page]
- Table 1—Symbols to convey medical device information
- Annex A (informative) Guidance and examples of symbol use, including multiple symbols [Go to Page]
- 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”
- 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”
- 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”
- 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”
- 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
- Annex B (informative) Use of general prohibition symbol and negation symbol [Go to Page]
- B.1 General prohibition symbol
- B.2 Negation symbol
- Bibliography [Go to Page]
