11.18.3 O
2
concentration response time
Characteristics valid at conditions specified
in ISO 80601-2-12, table 201.105.
Response time for oxygen concentration
to change from 21 % to 90 %
• Maximum 25 s at V
T
= 500 ml, for patient
categories and circuit configurations
intended to provide V
T
≥300 ml
• Maximum 35 s at V
T
= 150 ml, for patient
categories and circuit configurations
intended to provide 100 ml ≤V
T
≤ 300 ml
11.19 UDI Label
UDI Label
Global standard for identifying Medical Equipment,
example:
(01)07325710000007(11)140625(21)01311141
Unique Device Identification number
Each UDI number can be divided into several parts,
each referred to by their AI number '(#)'.
Application Identifier (AI)
GTIN - Global Trade Item Number(01)
Part number(241)
Batch no.(10)
Manufacturing date (YYMMDD)(11)
Exp. date (YYMMDD)(17)
Revision(20)
Serial number(21)
Count of items(30)
The GTIN consists of four parts:
0 732571 000021 2
ab c d
a. Package level
b. GS-1 company prefix
c. Item reference
d. Check digit
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