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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI\/ISO 15223-1:2022; Medical devices\u2014Symbols to be used with information to be supplied by the manufacturer\u2014Part 1: General requirements <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Copyright information Contents Page <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Background of ANSI\/AAMI adoption of ISO 15223-1:2021 <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4 General requirements 4.1 Future symbols 4.2 Requirements for usage 4.3 Other symbols 5 Symbols <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | Table 1\u2014Symbols to convey medical device information <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 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, \u201cManufacturer\u201d A.3 Examples of use of symbol 5.1.1, \u201cManufacturer\u201d, combined with 5.1.3, \u201cDate of manufacture\u201d A.4 Example of use of symbol 5.1.2, \u201cAuthorized representative in the European Community\/European Union\u201d <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | A.5 Examples of use of symbol 5.1.3, \u201cDate of manufacture\u201d A.6 Examples of use of symbol 5.1.4, \u201cUse-by date\u201d A.7 Examples of use of symbol 5.1.5, \u201cBatch code\u201d A.8 Examples of use of symbol 5.1.6, \u201cCatalogue number\u201d A.9 Examples of use of symbol 5.1.7, \u201cSerial number\u201d A.10 Examples of use of symbol 5.1.8, \u201cImporter\u201d <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | A.11 Examples of use of symbol 5.1.9, \u201cDistributor\u201d A.12 Examples of use of symbol 5.1.11, \u201cCountry of manufacture\u201d A.13 Examples of use of symbol 5.2.9 for \u201cSterile fluid path\u201d <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | A.14 Examples of use of symbol 5.3.8, \u201cHumidity limitation\u201d A.15 Example of use of symbol 5.3.9, \u201cAtmospheric pressure limitation\u201d A.16 Example of use of symbol 5.4.3, \u201cConsult instructions for use or consult electronic instructions for use\u201d for an electronic instruction for use (eIFU) A.17 Examples of use of symbol 5.5.5, \u201cContains sufficient for tests\u201d A.18 Example of use of symbol 5.7.1, \u201cPatient number\u201d <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | A.19 Examples of use of symbol 5.7.8, \u201cTranslation\u201d A.20 Examples of use of symbol 5.7.9, \u201cRepackaging\u201d A.21 Examples of use of symbol 5.7.10, \u201cUnique device identifier\u201d 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 <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | Annex B (informative) Use of general prohibition symbol and negation symbol B.1 General prohibition symbol B.2 Negation symbol <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 15223-1:2022, Medical devices\u2014Symbols to be used with information to be supplied by the manufacturer\u2014Part 1: General requirements<\/b><\/p>\n |