65Reference
Explanation of Symbols
Symbol
Title and Designation
Number of Standard,
Regulation or Guideline
Reference Number Title/Meaning of Symbol
Rx only
21CFR801.109 (b) (1) This symbol means
that an order from a
healthcare provider is
needed to use or sell the
drug or device.
ANSI/AAMI/ISO
15223-1:2021
5.2.3 Sterilized using ethylene
oxide
Applies to sterile
disposable parts.
ANSI/AAMI/ISO
15223-1:2021
5.2.4 Sterilized using irradiation
Applies to sterile
disposable parts.
ANSI/AAMI/ISO
15223-1:2021
5.7.7 Medical Device
ANSI/AAMI/ISO
15223-1:2021
5.4.12 The medical device can be
used multiple times by a
single patient.
References
ISO 15223-1:2021 Medical Devices ─ Symbols to be used with medical device labels,
labeling, and information to be supplied ─ Part 1: General Requirements
ISO 7010:2019 Graphical symbols ─ Safety colours and safety signs ─ Registered safety
signs
IEC 60529:2001 Degrees of protection provided by enclosure (IP code) IEC 60417:2002 DB
Graphical symbols for use on equipment
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR)
Environment, FDA Guideline May 20, 2021
21 CFR 801.109 Code of Federal Regulations Title 21 Volume 8 Sec.801.109 Prescription
Devices
ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in
the Magnetic Resonance Environment
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