Quality Standard - GERATHERM GT-868UF Manual De Instrucciones

Quality standard

Geratherm
tive 93/42/EEC andEN ISO 13485 and is entitled to af-
fi x the CE-mark
LGA Products GmbH).
The blood pressure monitor is compliant with
• EN 60601-1+A1
Medical electrical equipment. Part 1: General require-
ments for basic safety and essential performance.
• IEC/EN 60601-1-11
Medical electrical equipment. Part 1-11: General re-
quirements for basic safety and essential performance -
Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the
home healthcare environment.
• DIN EN ISO 81060-1
Non-invasive sphygmomanometers – Part 1: Require-
ments and test methods for non-automated measure-
ment type (ISO 81060-1)
EN
• DIN EN ISO 81060-2
Non-invasive sphygmomanometers – Part 2: Clinical
investigation of automated measurement type (ISO
81060-2)
• EN 1060-3
Non-invasive sphygmomanometers – Part 3: Supple-
mentary requirements for electro-mechanical blood
pressure measuring systems
is certifi ed in accordance with Council Direc-
®
CE 0197 (Notifi ed Body: TÜV Rheinland
42