AAMI 27185 2012 RA 2017
$140.32
ANSI/AAMI/ISO 27185:2012/(R)2017 – Cardiac rhythm management devices-Symbols to be used with cardiac rhythm management device labels, and information to be supplied-General requirements
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 48 |
Identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of cardiac rhythm management medical devices. The document is limited to symbols applicable to cardiac rhythm management medical devices that may be marketed globally. These symbols may be used on the device itself or its labels.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of ISO 27185:2011 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 15 | 4 Abbreviated terms 5 General requirements 5.1 Proposal of symbols for adoption 5.2 Requirements for usage |
| 16 | 6 Symbols |
| 28 | Annex A, Examples of use of symbols A.1 General A.2 Amplitude and pulse width, right atrial A.3 Sensitivity, right atrial |
| 29 | A.4 Atrial to ventricular interval, paced and sensed A.5 Maximum tracking rate and minimum rate |
| 30 | A.6 Header and bore graphics |
| 31 | Annex B, Graphical symbol system for implantable cardiac devices |
| 36 | Annex C, Validation report for symbols included in this International Standard C.1 Background C.2 Scope C.3 Sample size |
| 37 | C.4 Pass/fail criteria C.5 Survey test examples |
| 38 | C.6 Data |
| 39 | C.7 Interpretation of data C.8 Handling of outliers C.9 Rationale for no re-validation of symbols following recommended changes from ISO/TC 145/SC3 C.9.1 Symbol grouping 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.9 |
| 40 | C.9.2 Symbol grouping 6.10 to 6.24 C.9.3 Symbol grouping 6.28 and 6.29 |
| 41 | C.9.4 Symbol grouping 6.32 to 6.39 C.9.5 Symbol 6.42 C.10 Conclusion |
| 42 | Annex D, ISO 27185 response to comment in DIS |
| 43 | Bibliography |
