I.S. EN ISO 81060-1:2012
Current
The latest, up-to-date edition.
NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007)
Hardcopy , PDF
English
01-01-2012
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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.
| DevelopmentNote |
Supersedes I.S. EN 1060-1 and I.S. EN 1060-2. (06/2012)
|
| DocumentType |
Standard
|
| Pages |
55
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| ISO 81060-1:2007 | Identical |
| EN ISO 81060-1:2012 | Identical |
| UNE-EN ISO 81060-1:2012 | Equivalent |
| BS EN ISO 81060-1:2012 | Equivalent |
| DIN EN ISO 81060-1:2012-08 | Equivalent |
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