AAMI ISO 81060-1:2007(R2013)

Glossary of equivalent standards
Committee representation
Background of AAMI Adoption of ISO 81060-1:2007
AAMI inclusion to ISO 81060-1:2007
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Identification and marking
   4.1 Units of measurement
   4.2 Legibility of markings
   4.3 Durability of markings
   4.4 Marking of non-automated sphygmomanometer
   4.5 Usability of reading
   4.6 Marking of the cuff
   4.7 Marking of the non-automated sphygmomanometer
        packaging
5 General requirements for testing non-automated
   sphygmomanometers
   5.1 Type tests
   5.2 Representative sample
   5.3 Environmental conditions
   5.4 Repairs and modifications
   5.5 Humidity preconditioning treatment
6 General requirements
   6.1 General
   6.2 Electrical safety
   6.3 Mechanical safety
   6.4 Mechanical strength
7 Requirements
   7.1 Pressure indicating means
   7.2 Pneumatic system
   7.3 Tamper proofing or unauthorized access
   7.4 Dynamic response in normal use
   8 Additional requirements for non-automated
     sphygmomanometer with mercury manometer
   8.1 Internal diameter of the tube containing mercury
   8.2 Portable non-automated sphygmomanometer
   8.3 Prevention of mercury spillage during transport
   8.4 Prevention of mercury spillage in normal use
   8.5 Quality of the mercury
9 Non-automated sphygmomanometers with aneroid manometer
   9.1 Scale mark at zero
   9.2 Zero
   9.3 Hysteresis error
   9.4 Construction and materials
10 Cleaning, sterilization and disinfection
   10.1 Reusable non-automated sphygmomanometer and parts
   10.2 Non-automated sphygmomanometer and parts requiring
        processing before use
   10.3 Non-automated sphygmomanometer and parts delivered
        sterile
11 Biocompatibility
12 Information supplied by the manufacturer
   12.1 Accompanying document
   12.2 Instructions for use
   12.3 Technical description
Annex A (informative) - Rationale and guidance
Annex B (informative) - Advice regarding non-automated
                        sphygmomanometers with a mercury
                        manometer
Annex C (informative) - Environmental aspects
Annex D (informative) - Reference to the essential principals
Annex E (informative) - Terminology - Alphabetized index of
                        defined terms
Bibliography

This standard specifies requirements for mechanical sphygmomanometers and their accessories that, by means of an inflatable cuff, are used for the non-invasive measurement of blood pressure.