Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
Abstract
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.
DIN EN ISO 81060-1:2012-08 (E)
Non-invasive sphygmomanometers – Part 1: Requirements and test methods for nonautomated
measurement type (ISO 81060-1:2007)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 4
Introduction …………………………………………………………………………………………………………………………………… 5
1 * Scope ………………………………………………………………………………………………………………………….. 6
2 Normative references …………………………………………………………………………………………………….. 6
3 Terms and definitions …………………………………………………………………………………………………….. 7
4 Identification and marking ……………………………………………………………………………………………. 10
4.1 * Units of measurement ………………………………………………………………………………………………… 10
4.2 * Legibility of markings …………………………………………………………………………………………………. 10
4.3 * Durability of markings ………………………………………………………………………………………………… 10
4.4 * Marking of non-automated sphygmomanometer …………………………………………………………. 10
4.5 * Usability of reading …………………………………………………………………………………………………….. 11
4.6 Marking of the cuff ……………………………………………………………………………………………………….. 11
4.7 Marking of the non-automated sphygmomanometer packaging …………………………………….. 11
5 General requirements for testing non-automated sphygmomanometers ………………………… 12
5.1 * Type tests ………………………………………………………………………………………………………………….. 12
5.2 * Representative sample ……………………………………………………………………………………………….. 12
5.3 Environmental conditions …………………………………………………………………………………………….. 12
5.4 Repairs and modifications ……………………………………………………………………………………………. 12
5.5 * Humidity preconditioning treatment ……………………………………………………………………………. 12
6 General requirements …………………………………………………………………………………………………… 13
6.1 General ………………………………………………………………………………………………………………………… 13
6.2 Electrical safety ……………………………………………………………………………………………………………. 13
6.3 Mechanical safety …………………………………………………………………………………………………………. 13
6.4 Mechanical strength ……………………………………………………………………………………………………… 13
7 Requirements ………………………………………………………………………………………………………………. 15
7.1 Pressure indicating means …………………………………………………………………………………………… 15
7.2 Pneumatic system ………………………………………………………………………………………………………… 16
7.3 * Tamper proofing or unauthorized access ……………………………………………………………………. 19
7.4 Dynamic response in normal use ………………………………………………………………………………….. 19
8 Additional requirements for non-automated sphygmomanometer with mercury
manometer …………………………………………………………………………………………………………………… 20
8.1 * Internal diameter of the tube containing mercury ………………………………………………………… 20
8.2 * Portable non-automated sphygmomanometer …………………………………………………………….. 20
8.3 * Prevention of mercury spillage during transport …………………………………………………………. 20
8.4 * Prevention of mercury spillage in normal use ……………………………………………………………… 20
8.5 Quality of the mercury ………………………………………………………………………………………………….. 21
9 Non-automated sphygmomanometers with aneroid manometer ……………………………………. 21
9.1 * Scale mark at zero ……………………………………………………………………………………………………… 21
9.2 * Zero …………………………………………………………………………………………………………………………… 21
9.3 Hysteresis error ……………………………………………………………………………………………………………. 21
9.4 * Construction and materials ………………………………………………………………………………………… 22
10 Cleaning, sterilization and disinfection …………………………………………………………………………. 22
10.1 Reusable non-automated sphygmomanometer and parts ……………………………………………… 22
10.2 Non-automated sphygmomanometer and parts requiring processing before use ………….. 22
10.3 Non-automated sphygmomanometer and parts delivered sterile …………………………………… 23
11 Biocompatibility …………………………………………………………………………………………………………… 23
12 Information supplied by the manufacturer ……………………………………………………………………. 23
12.1 Accompanying document …………………………………………………………………………………………….. 23
12.2 Instructions for use ……………………………………………………………………………………………………… 23
12.3 Technical description …………………………………………………………………………………………………… 26
Annex A (informative) Rationale and guidance …………………………………………………………………………….. 28
Annex B (informative) Advice regarding non-automated sphygmomanometers with a mercury
manometer ………………………………………………………………………………………………………………….. 36
Annex C (informative) Environmental aspects ……………………………………………………………………………… 37
Annex D (informative) Reference to the essential principals …………………………………………………………. 38
Annex E (informative) Terminology — Alphabetized index of defined terms ………………………………….. 40
Bibliography ……………………………………………………………………………………………………………………………….. 41
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices ……………………………………….. 43