BS EN ISO 81060-1:2012
Current
The latest, up-to-date edition.
Non-invasive sphygmomanometers Requirements and test methods for non-automated measurement type
Hardcopy , PDF
English
31-07-2012
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
Describes 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.
| Committee |
CH/205/10
|
| DevelopmentNote |
Renumbers & supersedes BS ISO 81060-1. 2012 version incorporates corrigendum to BS ISO 81060-1. Supersedes 06/30137313 DC, BS EN 1060-1, BS EN 1060-2 & 11/30251468 DC. (07/2012)
|
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| ISO 81060-1:2007 | Identical |
| EN ISO 81060-1:2012 | Identical |
| I.S. EN ISO 81060-1:2012 | Equivalent |
| DIN EN ISO 81060-1:2012-08 | Equivalent |
| UNE-EN ISO 81060-1:2012 | Equivalent |
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