Standard List - Grundig MDI231 User Manual

15. Standard list

ShenZhen
Co.,Ltd. declares that the MDI231
complies with following applicable
standards:
EN 980
EN 1041
EN 60601-1
EN 60601-
1-2
EN 60601-
1-6
ISO 80601-
2-56
EN 60601-
1-11
EN 12470-5
ASTM
E1965
EN 62304
EN 62366
Medek
Symbols for use in the labeling of medical
Inf orma tion supplied b y the manufacturer
with medical devices
Medical electrical equipment Part 1: General
requirements for basic safety and essential
Medical electrical equipment -- Part 1-2:
General requirements for basic safety and
essential performance - Collateral standard:
Electromagnetic compatibility - Require-
Medical electrical equipment – Part1- 6:
General requirements for basic safety and
essential performance – Collateral standard:
Medical electrical equipment part 2-56:
particular requirements for basic safety and
essential performance of clinical thermome-
ters for body temperature measurement
Medical electrical equipment – Part 1-11:
General requirements for basic safety and
essential performance – Collateral standard:
Requirements for medical electrical equip-
ment and medical electrical systems used in
home healthcare environment
Clinical thermometers – Part 5: Performance
of infra-red ear thermometers (with maxi-
Standard Specification for Infrared Ther-
mometer for Intermittent Determination of
Patient Temperature
Medical device software - Software life-cycle
Medical devices – Application of usability
engineering to medical devices
Bio-Medical
devices
performance
ments and tests
Usability
mum device)
processes
28