ISO 81060-1:2007

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

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.

General Information

• Status: Published
• Publication Date: 18-Nov-2007
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 7 - TC 62/SC 62D/JWG 7
• Current Stage: PPUB - Publication issued
• Start Date: 31-Dec-2007
• Completion Date: 19-Nov-2007

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 81060-1
First edition
2007-12-01


Non-invasive sphygmomanometers —
Part 1:
Requirements and test methods for
non-automated measurement type
Sphygmomanomètres non invasifs —
Partie 1: Exigences et méthodes d'essai pour type à mesurage non
automatique



Reference number
ISO 81060-1:2007(E)
©
ISO 2007

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ISO 81060-1:2007(E)
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ISO 81060-1:2007(E)
Contents Page
Foreword. v
Introduction . vi
1 * Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Identification and marking . 5
4.1 * Units of measurement. 5
4.2 * Legibility of markings . 5
4.3 * Durability of markings. 5
4.4 * Marking of non-automated sphygmomanometer. 5
4.5 * Usability of reading . 6
4.6 Marking of the cuff. 6
4.7 Marking of the non-automated sphygmomanometer packaging. 6
5 General requirements for testing non-automated sphygmomanometers . 7
5.1 * Type tests. 7
5.2 * Representative sample . 7
5.3 Environmental conditions. 7
5.4 Repairs and modifications. 7
5.5 * Humidity preconditioning treatment . 7
6 General requirements. 8
6.1 General.
...