EN ISO 81060-1:2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Identification and marking
5 General requirements for testing non-automated
   sphygmomanometers
6 General requirements
7 Requirements
8 Additional requirements for non-automated sphygmomanometer
   with mercury manometer
9 Non-automated sphygmomanometers with aneroid manometer
10 Cleaning, sterilization and disinfection
11 Biocompatibility
12 Information supplied by the manufacturer
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
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on medical devices

ISO 81060-1:2007 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.ISO 81060-1:2007 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.ISO 81060-1:2007 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow.