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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, 2016
- ANSI/AAMI/ISO 15223-1:2016; Medical Devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI/ISO 15223-1
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements [Go to Page]
- 4.1 Proposal of symbols for adoption
- 4.2 Requirements for usage
- 4.3 Other symbols
- 5 Symbols [Go to Page]
- Table 1 — Symbols to convey information essential for proper use
- Annex A (informative) Examples [Go to Page]
- 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”
- 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”
- 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”
- 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)
- 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]