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.
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
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