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UNI EN ISO 81060-1 : 2012

Current
Current

The latest, up-to-date edition.

NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
Published date

22-11-2012

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
CT 44
DevelopmentNote
Supersedes UNI EN 1060-1 and UNI EN 1060-2. (11/2012)
DocumentType
Test Method
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

Standards Relationship
ISO 81060-1:2007 Identical
EN ISO 81060-1:2012 Identical

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