3
1. Safety Criteria
CE Marking
ISO 15223-1:2016 Ref no: 5.7.7 Medical Device
ISO 15223-1:2016 Ref no: 5.1.1 Manufacturer
ISO/DIS 20417 2019 Section 3.26 Single Patient -
multiple use
ISO 15223-1:2016 Ref no: 5.2.8 Do not use if
package is damaged
ISO 15223-1:2016 Ref no: 5.1.3 Date of
manufacture
ISO 7010-W012
:
Warning, electricity
ISO 15223-1:2016 Ref no: 5.1.7 Serial number
ISO 15223-1:2016 Ref no: 5.1.6 Catalogue number
ISO 15223-1:2016 Ref no: 5.1.9 Distributor
ISO 15223-1:2016 Ref no: 5.1.2 Authorized
representative in the European Community
ISO 15223-1:2016 Ref no:5.7.10 Unique Device
Identifier
ISO 15223-1:2016 Ref no: 5.2.7 Non-sterile
IEC 60417-5333
:
TYPE BF APPLIED PART
ISO 15223-1:2016 Ref no:5.3.7 Temperature
limitation
IEC 60417-5172
:
Class II Equipment
ISO 7000-0434A
:
Caution