AAMI ISO 81060-1:2007(R2013)
Current
The latest, up-to-date edition.
NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
English
26-06-2013
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.
| Committee |
WG 07
|
| DocumentType |
Test Method
|
| ISBN |
1-57020-314-8
|
| Pages |
54
|
| ProductNote |
Reconfirmed 2013
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 81060-1:2007 | Identical |
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