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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, 2012
- ANSI/AAMI/ISO 27185:2012, Cardiac rhythm management devices--Symbols to be used with cardiac rhythm management device labels, and information to be supplied--General requirements
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI adoption of ISO 27185:2011
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Abbreviated terms
- 5 General requirements [Go to Page]
- 5.1 Proposal of symbols for adoption
- 5.2 Requirements for usage
- 6 Symbols
- Annex A, Examples of use of symbols
[Go to Page]
- A.1 General
- A.2 Amplitude and pulse width, right atrial
- A.3 Sensitivity, right atrial
- A.4 Atrial to ventricular interval, paced and sensed
- A.5 Maximum tracking rate and minimum rate
- A.6 Header and bore graphics
- Annex B, Graphical symbol system for implantable cardiac devices
- Annex C, Validation report for symbols included in this International Standard
[Go to Page]
- C.1 Background
- C.2 Scope
- C.3 Sample size
- C.4 Pass/fail criteria
- C.5 Survey test examples
- C.6 Data
- 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
[Go to Page]
- C.9.1 Symbol grouping
6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.9
- C.9.2 Symbol grouping 6.10 to 6.24
- C.9.3 Symbol grouping 6.28 and 6.29
- C.9.4 Symbol grouping 6.32 to 6.39
- C.9.5 Symbol 6.42
- C.10 Conclusion
- Annex D, ISO 27185 response to comment in DIS
- Bibliography
[Go to Page]