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QUALITY STANDARD
Geratherm
is certifi ed in accordance with Council Directive 93/42/EEC and EN ISO 13485
®
and is entitled to affi x the CE-mark
GmbH).
The blood pressure monitor is compliant with
• EN 60601-1 +A1 Medical electrical equipment. Part 1: General requirements for basic
safety and essential performance.
• IEC/EN 60601-1-11 Medical electrical equipment. Part 1-11: General requirements for
basic safety and essential performance - Collateral standard: Requirements for medi-
cal electrical equipment and medical electrical systems used in the home healthcare
environment.
• DIN EN ISO 81060-1
Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-
automated measurement type (ISO 81060-1)
• DIN EN ISO 81060-2
Non-invasive sphygmomanometers – Part 2: Clinical investigation of automated meas-
urement type (ISO 81060-2)
• EN 1060-3
Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-
mechanical blood pressure measuring systems
(Notifi ed Body: TÜV Rheinland LGA Products
EN
15 - EN
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