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NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 26-06-2013
Publisher: Association for the Advancement of Medical Instrumentation
Glossary of equivalent standards Committee representation Background of AAMI Adoption of ISO 81060-1:2007 AAMI inclusion to ISO 81060-1:2007 ForewordIntroduction 1 Scope 2 Normative references3 Terms and definitions4 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 packaging5 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 treatment6 General requirements 6.1 General 6.2 Electrical safety 6.3 Mechanical safety 6.4 Mechanical strength7 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 mercury9 Non-automated sphygmomanometers with aneroid manometer 9.1 Scale mark at zero 9.2 Zero 9.3 Hysteresis error 9.4 Construction and materials10 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 sterile11 Biocompatibility12 Information supplied by the manufacturer 12.1 Accompanying document 12.2 Instructions for use 12.3 Technical descriptionAnnex A (informative) - Rationale and guidanceAnnex B (informative) - Advice regarding non-automated sphygmomanometers with a mercury manometerAnnex C (informative) - Environmental aspectsAnnex D (informative) - Reference to the essential principalsAnnex 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.
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