AbbVie VYAFUSER - Reference; Explanation of Symbols

63Reference
Explanation of Symbols
12. Reference
12.1 Explanation of Symbols
Symbol
Title and Designation
Number of Standard,
Regulation or Guidance
Reference Number Title/Meaning of Symbol
ISO 7010:2019 ISO 7010-W001 General Warning Sign
ANSI/AAMI/ISO
15223-1:2021
5.1.1 Manufacturer
ANSI/AAMI/ISO
15223-1:2021
5.1.3 Date of Manufacture
ANSI/AAMI/ISO
15223-1:2021
5.1.5 Batch Code
ANSI/AAMI/ISO
15223-1:2021
5.1.6 Catalog Number
ANSI/AAMI/ISO
15223-1:2021
5.1.7 Serial Numbers
ANSI/AAMI/ISO
15223-1:2021
5.3.4 Keep Dry
ANSI/AAMI/ISO
15223-1:2021
5.3.7 Temperature Limits
ANSI/AAMI/ISO
15223-1:2021
5.3.8 Humidity Limitation
ANSI/AAMI/ISO
15223-1:2021
5.3.9 Atmospheric Pressure
Limitation
1. ASTM F2503-20
2. Testing and Labeling
Medical Devices for
Safety in the Magnetic
Resonance (MR)
Environment, FDA
Guideline May 20, 2021
1. Figure 9
2. VIII
MR Unsafe
The device is magnetic
resonance unsafe. Keep the
device away from places
with magnetic resonance,
such as MRI scanner rooms.