ISO 81060-1:2007 PDF

Scope: This part of ISO 81060 specifies 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. This part of ISO 81060 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement. The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow. EXAMPLE 1 A stethoscope for detecting Korotkoff sounds, Doppler ultrasound or other manual methods. Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressure sensing elements and/or displays used in conjunction with other automatic methods determining blood pressure are specified in IEC 60601-2-30 [7]. Requirements for invasive blood pressure measurement equipment that directly measure blood pressure are specified in document IEC 60601-2-34 [8]. EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement of circulatory system pressures.

ISO 81060-1:2007 Referenced Document

IEC 60601-1 Medical electrical equipment - ALL PARTS*， 2015-01-20 Update
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 14937 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices*， 2009-10-01 Update
ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 7010:2003 Graphical symbols - Safety colours and safety signs - Safety signs used in workplaces and public areas

2007 ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type