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AAMI ISO 81060-1 : 2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
Available format(s)

Hardcopy , PDF

Superseded date

31-08-2021

Language(s)

English

Published date

01-01-2013

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

Describes the requirements for non-automated sphygmomanometers, as defined in 3.11, and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.

Committee
WG 07
DocumentType
Standard
Pages
54
ProductNote
Reconfirmed 2007
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

Standards Relationship
ISO 81060-1:2007 Identical

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