Regulatory Information
Regulatory Information
53
52
Symbol
Symbol Meaning
Applicable Standard
Symbol
Number
Manufacturer symbol – To identify the
manufacturer of a product
Manufacturer
BS EN ISO 15223-1:2021
5.1.1
EEA/EU/EC European Authorised
Representative symbol
Authorized representative in
the European Community
BS EN ISO 15223-1:2021
5.1.2
Date of manufacture symbol – To indicate the
date on which a product was manufactured
Date of Manufacture
BS EN ISO 15223-1:2021
5.1.3
Indicates the manufacturer’s catalogue
number so the medical device can be
identified
Catalogue Number
BS EN ISO 15223-1:2021
5.1.6
Serial Number
BS EN ISO 15223-1:2021
5.1.7
Medical Device
BS EN ISO 15223-1:2021
5.7.7
Keep Dry
BS EN ISO 15223-1:2021
5.3.4
Temperature Limit
BS EN ISO 15223-1:2021
5.3.7
Humidity Limitation
BS EN ISO 15223-1:2021
5.3.8
Caution
BS EN ISO 15223-1:2021
5.4.4
General warning sign
EC 60601-1, Reference no.
Table D.2, Safety sign 2
ISO 7010-W001
Refer to user manual
EC 60601-1, Reference no.
Table D.2, Safety sign 10
ISO 7010-M002
WEEE (Waste Electrical and Electronic
Equipment) Directive symbol
Collect Separately
DIRECTIVE 2012/19/EU (WEEE)
Annex IX
Class II or double insulated electrical
appliance symbol
Class II equipment
IEC 60417
Reference no. Table D.1
Symbol 9 (IEC 60417-
5172)
Symbol
Symbol Meaning
Applicable Standard
Symbol
Number
Direct current
IEC 60601-1
Reference no. Table D.1
IEC 60417-5031
Norma Oficial Mexicana logo
NOM Certification symbol
Norma Oficial Mexicana
N/A
Korea KCC Mark
KS A 0062
N/A
Degree of protection
IEC 60601-1 (IEC 60529)
Table D.3
Code 2
Recycling Symbol
European Parliament and
Council Directive 94/62/EC
Annex I-VII
ALTERNATE Non-ionizing electromagnetic
radiation symbol
Non-ionizing
electromagnetic radiation
IEC 60417
7000-5140