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NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
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Superseded date: 31-07-2012
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Published date: 23-11-2012
Publisher: British Standards Institution
ForewordIntroduction1 Scope2 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 use8 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 termsBibliography
Defines 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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