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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI\/ISO 15223-1:2016; Medical Devices\u2014Symbols to be used with medical device labels, labelling and information to be supplied\u2014Part 1: <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Background of ANSI\/AAMI\/ISO 15223-1 <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4 General requirements 4.1 Proposal of symbols for adoption 4.2 Requirements for usage <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.3 Other symbols 5 Symbols <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | Table 1 \u2014 Symbols to convey information essential for proper use <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Annex A (informative) Examples A.1 Example of use of symbol 5.1.1, \u201cManufacturer\u201d A.2 Example of use of symbol 5.1.1, \u201cManufacturer\u201d, combined with 5.1.3, \u201cDate of manufacture\u201d A.3 Example of use of symbol 5.1.2, \u201cAuthorized representative in the European Community\u201d A.4 Examples of use of symbol 5.1.3, \u201cDate of manufacture\u201d <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | A.5 Examples of use of symbol 5.1.4, \u201cUse-by date\u201d A.6 Example of use of symbol 5.1.5, \u201cBatch code\u201d A.7 Example of use of symbol 5.1.6, \u201cCatalogue number\u201d A.8 Example of use of symbol 5.1.7, \u201cSerial number\u201d A.9 Examples of use of symbols for \u201cSterile fluid path\u201d <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | A.10 Examples of use of symbols for temperature limits A.11 Examples of use of symbol 5.3.8, \u201cHumidity limitation\u201d A.12 Example of use of symbol 5.3.9, \u201cAtmospheric pressure limitation\u201d <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | A.13 Examples of use of symbol 5.5.5, \u201cContains sufficient for tests\u201d A.14 Example of use of symbol 5.7.1, \u201cPatient number\u201d A.15 Example of use of symbol 5.4.3, \u201cConsult instructions for use\u201d for an electronic instruction for use (eIFU) <\/td>\n<\/tr>\n | ||||||
| 37<\/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 | ||||||
| 38<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" 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<\/b><\/p>\n |