Quality Standard - GERATHERM Active Control+ GT-1115 Manual

Quality standard

Geratherm
tive 93/42/EEC and EN ISO 13485 and is entitled to affix
the CE-mark
Products GmbH).
The blood pressure monitor conforms to
Risk management
Labelling
Instructions
General Require-
ments for Safety
EN
Electromagnetic
compatibility
Performance
requirements
is certified in accordance with Council Direc-
®
(Notified Body: TÜV Rheinland LGA
ISO/EN 14971
Medical devices — Application of risk
management to medical devices
EN 980 symbols for the labelling of medi-
cal devices
EN 1041
Medical equipment manufac-turers to
provide information
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
medical electrical equipment and medical
electrical systems used in the home
healthcare environment
IEC/EN 60601-1-2
Medical electrical equipment – Part 1-2:
General requirements for basic safety and
essential performance
– Collateral standard: Electromagnetic
compatibility - Requirements and tests.
EN ISO 81060-1
Non-invasive sphygmomanometers – Part
1: Require- ments and test methods for
non-automated measurement type (ISO
81060-1)
EN 1060-3 +A2
Non-invasive blood pressure monitor - Part
3: Supplementary requirements for elec-
tromechanical blood pressure measuring
system
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