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39
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Notes38
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Additional guidance
Regulatory information
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
instruction
manual/booklet
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 201
2/19/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)
Australia’s ACMA Regulatory Compliance
Mark
Regulatory
Compliance Mark
(RCM)
AS/NZS 4417.1:2012 N/A
Giteki Mark Japanese Radio Law N/A
Direct current
IEC 60601-1
Reference no.
Table D.1
IEC 60417-
5031
Recycling Symbol
European Parliament
and Council
Directive 94/62/EC
Annex I-VII