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Labeling of Cellular Therapy Products: Isbt 128 Standard
Labeling of Cellular Therapy Products: Isbt 128 Standard
Version 1.2.0
November 2018
Tracking Number ICCBBA ST-004
ISBN-13: 978-1-933243-84-9
ISBN-10: 1-933243-84-8
Published by:
ICCBBA
PO Box 11309, San Bernardino, CA 92423-1309 USA
Labeling of Cellular Therapy Products v1.2.0 2
Editor
Mónica Freire, BS
Standards Development Manager, ICCBBA
Standards Committee
ICCBBA provides no representation or warranty that the Licensee’s use of ISBT 128 is suitable for
any particular purpose and the selection, use, efficiency and suitability of ISBT 128 is the sole
responsibility of the Licensee.
ICCBBA’s liability is limited to that specified in the ICCBBA License Agreement which is available on
the ICCBBA website. Under no circumstances shall ICCBBA’s liability to licensee or any third party
under any theory or cause of action exceed the current annual license fee payable by the licensee to
ICCBBA hereunder, and ICCBBA will in no circumstances be liable for any direct or indirect damages
whatsoever, including without limitation special, incidental, consequential, or punitive damages or
damages for loss of data, business or goodwill or any other consequential losses of any nature arising
from the use of ISBT 128 or the marks.
COPYRIGHT NOTICE
Copyright 2018. ISBT 128 is not in the public domain and is protected by law. Implementation of ISBT
128 requires the end-user to register with ICCBBA and to pay an annual license fee. License fees are
established by the ICCBBA Board of Directors to cover the expenses of maintaining and extending
ISBT 128, and making available current versions of the documents and database tables that are
needed to implement this Standard.
This Standard is intended for the use of those implementing ISBT 128, regulatory agencies, and
software developers and other manufacturers that support end-users.
Although it is made available to anyone wishing to obtain a copy, national “Guidelines” describing its
use in a particular country may be an additional source of information for the end-user. If such
“Guidelines” exist, they must be consulted because there are options in ISBT 128, and country-
specific information pertaining to the particular use of such options will only be found in such
“Guidelines.”
Any use of this Guideline, or the accompanying database tables, by other than registered
organizations, or facilities that have obtained their computer software from a registered and licensed
developer, is strictly forbidden. Copying any portion of the Standard, or of any accompanying
database table, either in electronic or other format, without express written permission from ICCBBA
is strictly forbidden. Posting of any portion of the Standard, or of any accompanying database table, to
any online service by anyone other than ICCBBA is strictly forbidden.
There are no guarantees or warranties attached to this Standard other than that ICCBBA, Inc agrees
to furnish registered and licensed end-users with the most up-to-date information available.
Successful implementation of this Standard, and use of any accompanying database table(s),
depend(s) upon the correct incorporation of the rules and table contents into the software used by or
provided to the registered and licensed facility. ICCBBA, Inc makes no other warranties of any kind,
whether expressed or implied, including any implied warranty of merchantability or fitness for any
particular purpose. Further information can be found at www.iccbba.org.
Table of Contents
1 Introduction ......................................................................................................................... 6
1.1 Purpose ....................................................................................................................... 6
1.2 Scope .......................................................................................................................... 6
1.3 Intended Audience ....................................................................................................... 6
1.4 Normative References ................................................................................................. 6
1.5 Other References ........................................................................................................ 6
1.6 Background.................................................................................................................. 7
1.7 Changes in This Version .............................................................................................. 8
2 Data Structures ..................................................................................................................13
3 General Labeling Considerations .......................................................................................14
3.1 General Principles.......................................................................................................14
3.2 Label Size ...................................................................................................................14
3.3 Minimum Requirements for ISBT 128 Labels ..............................................................15
3.4 Other Minimum Label Requirements ...........................................................................15
3.5 National Labeling Guidelines ......................................................................................16
4 Electronically Readable Symbols .......................................................................................17
5 Bar Code and 2-D Symbol Placement................................................................................18
5.1 Base Label ..................................................................................................................18
5.2 100 mm x 100 mm Product Label ...............................................................................19
5.3 Partial Labels ..............................................................................................................22
5.4 Location of the GRID on a 100 mm x 100 mm Label ...................................................23
6 Text....................................................................................................................................24
6.1 Donation Identification Number [Data Structure 001] ..................................................25
6.2 Facility ........................................................................................................................26
6.3 Blood Groups [ABO and RhD] ....................................................................................27
6.4 Product Descriptions ...................................................................................................28
6.5 Dates ..........................................................................................................................29
6.6 Text Not Associated with Electronically Readable Information ....................................31
6.7 Global Registration Identifier for Donors .....................................................................31
7 Label Examples .................................................................................................................32
7.1 Full 100 mm x 100 mm Label ......................................................................................32
7.2 Labeling Containers Smaller than 100 mm x 100 mm .................................................37
8 Glossary ............................................................................................................................40
9 Annex – Joint Statement ....................................................................................................43
Tables
Table 1 Positioning Bar Codes on the Base Labels [RT020] ....................................................18
Table 2 Positioning of Bar Codes on a 100 mm x 100 mm Cellular Therapy Label [RT062] .....20
Table 3 Recommended Bar Code Alignment on a 100 mm x 100 mm Cellular Therapy Label
[RT063] .....................................................................................................................................21
Figures
Figure 1 Minimum ISBT 128 Information ..................................................................................15
Figure 2 Minimum ISBT 128 Requirements and Additional Information – Linear ......................15
Figure 3 Minimum ISBT 128 Requirements and Additional Information – 2-D ..........................16
Figure 4 Comparison of 2-D and Linear Bar Codes ..................................................................17
Figure 5 Placement and Nominal Size of Bar Codes on Base Label ........................................19
Figure 6 Placement and Nominal Size of Bar Codes on Final Label.........................................22
Figure 7 Examples of Data Labels (in Red Boxes) ...................................................................24
Figure 8 Representation of Flag Characters.............................................................................25
Figure 9 Upper Left Quadrant Facility Text...............................................................................26
Figure 10 Upper Left Quadrant for Matched, Unrelated Donor .................................................26
Figure 11 Upper Right Quadrant for Designated or Directed Collection ...................................27
Figure 12 Upper Right Quadrant for “Non-Specified” Collection ...............................................27
Figure 13 Example of Relative Size of Class and Attributes Text .............................................28
Figure 14 Printing of “Yes/No” Attributes ..................................................................................29
Figure 15 Collection Label........................................................................................................32
Figure 16 Label at Time of Release of Product (Designated) ...................................................33
Figure 17 Label at Time of Release of Product (Autologous Biohazard)...................................33
Figure 18 Label at Time of Release of Product (Autologous, Not Biohazard) ...........................34
Figure 19 Flexible Date and Time ............................................................................................35
Figure 20 GRID in Eye-Readable Text Only .............................................................................35
Figure 21 GRID in Linear Bar Code and Eye-Readable Text ...................................................36
Figure 22 GRID in 2-D Symbol and Eye-Readable Text...........................................................36
Figure 23 48 mm x 76 mm Final Label (Designated) ................................................................37
Figure 24 48 mm x 76 mm Final Label (Autologous Biohazard) ...............................................37
Figure 25 96 mm x 38 mm Final Label (Designated) ................................................................38
Figure 26 96 mm x 38 mm Final Label (Autologous, Biohazard) ..............................................38
Figure 27 Cryo Vial Label .........................................................................................................39
Figure 28 Other Small Labels...................................................................................................39
1 Introduction
1.1 Purpose
This document is intended to help facilities, label vendors, and software developers
design appropriate ISBT 128 labels for cellular therapy products.
1.2 Scope
This document provides guidance in the design of labels for cellular therapy products
following the standards described in the ISBT 128 Standard Technical Specification (ST-
001). Because container sizes for these products vary considerably, only a sampling of
possible label designs is provided.
This document addresses affixed labels in the ISBT 128 format. It does not address the
design of attached labels or accompanying documents.
ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002)
Implementation Guide: Use of Flexible Date and Time [Data Structure 031] (IG-024)
AABB
AABB Standards for Cellular Therapy Services (available from AABB at
http://www.aabb.org)
FACT
Foundation for the Accreditation of Cellular Therapy (FACT) Standards
http://www.factwebsite.org/Standards/
JACIE
Joint Accreditation Committee of ISCT and EBMT Standards
http://www.jacie.org/
NetCord-FACT Standards
http://www.factwebsite.org/Standards/
WMDA
World Marrow Donor Association (WMDA) Standards
https://www.wmda.info/professionals/quality-and-accreditation/wmda-standards/
WBMT
The Worldwide Network for Blood and Marrow Transplantation Position Paper can be
found at:
https://www.wbmt.org/fileadmin/pdf/01_General/WBMT_position_statement_for_Europe
an_Labeling_and_ISBT.pdf
1.6 Background
A Specification, ISBT 128, for labeling blood products was developed by the
International Society of Blood Transfusion Working Party on Automation and Data
Processing (WPADP) [now called the Working Party on Information Technology] and
published by ICCBBA in 1995. Countries around the world are in various stages of
implementation, and the model originally developed by the WPADP has demonstrated
its suitability by accommodating regional changes without substantial structural change.
It was recognized almost immediately that the ISBT 128 Standard would be useful for
cellular therapy products as well as blood products. A small number of facilities began
using ISBT 128 for these products in the late 1990s. However, greater international
standardization in terminology and labeling was needed to allow the use of the Standard
to become widespread. This goal was met through the co-operative endeavor of the
following organizations:
• AABB
• American Society for Blood and Marrow Transplantation (ASBMT)
• American Society for Apheresis (ASFA)
• Asia-Pacific Blood and Marrow Transplantation Group (APBMT)
• European Society for Blood and Marrow Transplantation (EBMT)
• Foundation for the Accreditation of Cellular Therapy (FACT)
• ICCBBA
• International Society of Blood Transfusion (ISBT)
• International Society for Cell and Gene Therapy (ISCT)
• Joint Accreditation Committee of ISCT and EBMT (JACIE)
• National Marrow Donor Program (NMDP)
• World Marrow Donor Association (WMDA)
The organizations supporting this Standard believe that its adoption will significantly
improve the quality, safety, and traceability of cellular therapy products.
Version
Version 1.1.0
1.2.0
Chapter,
Chapter,
Section, Change Rationale
Section,
Table, or
Table, or
Figure
Figure
1 Acknowledg N/A Removed the The acknowledgement is
ement Acknowledgement no longer needed.
section.
2 1.5 and 3.4 1.5 and 3.4 Removed No longer used as a
reference to reference.
AHCTA.
3 1.5 1.5 Removed WMDA The WMDA Position
Position Paper Paper reference is no
reference and longer valid.
replaced it with the
WBMT Position
Paper.
4 1.6 1.6 Updated names of To reflect the current
the APBMT, names used on their
EBMT, and ISCT. respective websites.
Version
Version 1.1.0
1.2.0
Chapter,
Chapter,
Section, Change Rationale
Section,
Table, or
Table, or
Figure
Figure
5 3.1 3.1 Removed FACT This definition is no
and JACIE longer accurate per the
definition for a Seventh Edition of the
partial label. FACT-JACIE International
Standards for
Hematopoietic Cellular
Therapy Product
Collection, Processing,
and Administration.
6 3.3 3.3 Changed the “2-D” is referring to the
wording from “2-D Data Matrix symbol on
label” to “2-D the label and not the label
symbol.” itself.
7 4 4 Updated wording To clarify that imaging
for use of imaging scanners are becoming
scanners. more widely available.
8 4 4 Added text that The receiving system
the use of imaging software may require
scanners may changes in order to
require changes to decode the compound
receiving system message read by imaging
software. scanners.
9 5 5 Added “and 2-D The chapter also provides
Symbol” to the direction for the
chapter title. placement of the 2-D
symbol on labels.
10 5.1 5.1 Updated Table To reflect the most recent
RT020. version of RT020 in ST-
005.
11 5.2 5.2 Added text that This text was added to
the inclusion of the clarify the information
bar code for Data previously presented only
Structure 005 is in a table.
strongly
recommended and
is anticipated to be
a requirement in
the future.
Version
Version 1.1.0
1.2.0
Chapter,
Chapter,
Section, Change Rationale
Section,
Table, or
Table, or
Figure
Figure
12 5.2 5.2 Removed Tables The new tables more
RT022, RT023, accurately reflect the
and RT024 and Standard.
added the new
Tables RT062 and
RT063.
13 5.2 5.2 Reworded To reference the
paragraphs information now located
referencing Tables in new Tables RT062 and
RT022, RT023, RT063.
and RT024 for bar
code positioning.
14 Figure 6 Figure 6 Removed the To clarify which bar codes
reference to are required on a cellular
Recommended therapy label and which
Bar Codes and ones are optional.
placed all optional
data structures
under the Optional
Bar Codes and
Symbols section.
15 N/A 5.4 Added section To provide instructions
for GRID location for the placement of the
on a 100 mm x GRID linear bar code on
100 mm label. cellular therapy labels.
16 6 6 Removed ICCBBA no longer uses
references to Bar this terminology. Chapter
Code Text, Data updated to match the text
Content Text, and requirements in ST-001.
Additional Text.
17 6 6 Removed In the ISBT 128 Standard
requirement for Technical Specification
san serif print. (ST-001), the focus is on
clarity of text instead of
particular font types and
sizes.
Version
Version 1.1.0
1.2.0
Chapter,
Chapter,
Section, Change Rationale
Section,
Table, or
Table, or
Figure
Figure
18 6.2.1 6.1 Added Check To reflect information in
Character ST-001 that the manual
information to check character should
Donation be used to ensure the
Identification accuracy of keyboard
Number Data data entry.
Structure section.
19 3.3, 6.3.2, 3.3, 6.3, and Changed This was a decision by
and 8 8 “Donation” to the Standards Committee
“Collection” for all to move toward Collection
references to Type instead of Donation
Donation Type Type as not all collections
Code and types of are donations.
donations.
20 6.3.3 6.4 Added “shall be The printed Class name
printed” after is a requirement for
Class name. cellular therapy products.
Version
Version 1.1.0
1.2.0
Chapter,
Chapter,
Section, Change Rationale
Section,
Table, or
Table, or
Figure
Figure
24 6.3.4 6.5 Changed the local To link the time zones in
time and time the example to those
zone in the UTC used in the note below it
example from EST for visual reference.
to CST.
25 N/A Figure 7 Added an example For clarification of the text
showing the data and to show examples of
labels. data labels.
26 N/A 6.7 Added section This information has
for eye-readable been added to the ISBT
presentation of 128 Standards (located
the GRID. in ST-015).
27 N/A Figure 20 , Added Figures 20 To provide information
Figure 21, - 22 as examples needed for labeling
and Figure of labels with the products with the GRID.
22 GRID.
28 8 8 Updated To match the current
definitions in the definitions in ST-001.
glossary.
29 8 8 Changed the To match the terminology
section header in used in Figure 2, Section
the glossary from 2.4.1 in ST-001 for the
“Terminology Donation Identification
Used in Donation Number Data Structure.
Numbering” to
“Terminology
Used in ISBT 128
Donation
Numbering.”
Note: The following changes were made to version 1.1.0 of this document and
inadvertently missed in the version changes table in Section 1.7:
1. The term “eye-readable text” was changed to “data content text” in Chapter 6
because the term “eye-readable” had a different meaning outside ISBT 128 that
caused confusion.
2. A paragraph on the Flexible Date and Time [Data Structure 031] was added to
Section 6.3.4 as a result of the new data structure added to the ISBT 128 Standard.
2 Data Structures
The data structures that are commonly used to label cellular therapy products include:
Detailed information for all data structures is found in the ISBT 128 Standard Technical
Specification (ST-001).
• Product labels that are applied by cellular therapy facilities. Different types of product
labels include:
o The label at the completion of product collection
o The label at the completion of processing
o The label at distribution for administration
o A partial label that can be either an in-process product label or the label on a
product that is ready for administration
• Primary considerations in label design shall include improving the safety of the
product and the efficiency of processing/administering. If these two considerations
conflict, safety shall take precedence over efficiency.
• Critical information on the container shall dominate the label via position and
prominence and shall take precedence over information that is of less importance to
the end-user (clinician, nurse, laboratory staff, and other hospital personnel).
Because of differences in languages and regulations, text that appears on the label, as
well as the location of that text, is left to national authorities. However, examples are
provided for guidance in determining where text may be placed. Bar code placement is
more strictly standardized.
The ISBT 128 Standard, therefore, does not specify a particular size of label. However, a
100 mm x 100 mm label is considered a routine label size when the size of the container
permits. This allows label stock typically used for blood banks to be used for cellular
therapy products.
• The eye-readable Product Code (Product Description Code, Collection Type Code,
and Division Code). If this text does not appear in conjunction with a bar code (e.g.,
there is no linear bar code for Product Code or a 2-D symbol is used), the word
“Product” shall precede the Product Code, see Figure 1 and Figure 2.
Specifications (quality, dimensions, etc.) for the printing of electronically readable symbols are
found in the ISBT 128 Standard Technical Specification (ST-001).
The base label should carry the two manufacturer’s information bar codes:
• The Container Manufacturer and Catalog Number [Data Structure 017] bar code in
the lower left quadrant
• The Container Lot Number [Data Structure 018] bar code in the lower right quadrant
The recommended position for these bar codes on a 100 ± 2 mm x 106 ± 2 mm label is
indicated in Table 1 and shown on Figure 5.
1 2
• The bar codes for the Donation Identification Number [Data Structure 001] and
Product Code [Data Structure 003] shall be present.
• When known at the time of labeling, the bar code for the Blood Groups [ABO and
RhD] [Data Structure 002] shall be present.
• The inclusion of the bar code for the Expiration Date and Time [Data Structure 005]
or the Flexible Date and Time [Data Structure 031], if known at the time of labeling, is
strongly recommended. It is anticipated this will be a requirement in the future.
The product label design shall be based upon the concept of four equal quadrants, 50 ±
1 mm x 50 ± 1 mm each. The bar codes shall be placed in these quadrants as indicated
in Table 2.
Table 2 Positioning of Bar Codes on a 100 mm x 100 mm Cellular Therapy Label [RT062]
Optional:
• Collection Date [Data Structure 006]
• Collection Date and Time [Data Structure 007]
• Production Date and Time [Data Structure 009]
• Flexible Date and Time [Data Structure 031] - Encoding the collection or
production date and time
Lower Left Required to be printed:
• Product Code [Data Structure 003]
Upper Right Required to be printed when known at the time of labeling:
• Blood Groups [ABO and RhD] [Data Structure 002]
Optional:
• Global Registration Identifier for Donors [Data Structure 039]
Lower Right Strongly recommended to be printed when known at the time of labeling:
• Expiration Date and Time [Data Structure 005] or
• Flexible Date and Time [Data Structure 031] - Encoding the expiration date
and time
Donation Identification 3 ± 2 mm from top of Upper Bar code right edge should be
Number [001] Left Quadrant* 4 ± 2 mm from right edge of
Upper Left Quadrant*
Product Code [003] 3 ± 2 mm from top of Lower Bar code right edge should be
Left Quadrant* 4 ± 2 mm from right edge of
Lower Left Quadrant*
Blood Groups [ABO and 3 ± 2 mm from top of Upper Bar code left edge should be 4
RhD] [002] Right Quadrant* ± 2 mm from left edge of Upper
Right Quadrant*
Expiration Date and Time 3 ± 2 mm from top of Lower Bar code left edge should be 4
[005 or 031] Right Quadrant* ± 2 mm from left edge of Lower
Right Quadrant*
Collection Date (and Time) 20 ± 2 mm from top of Upper Bar code right edge should be
[006, 007, or 031] or Left Quadrant 4 ± 2 mm from right edge of
Production Date and Time Upper Left Quadrant
[009 or 031]
*Concatenation distances must also be maintained
When present, the Data Matrix symbol shall include the Donation Identification Number
and Product Code Data Structures. It should also include the Blood Groups [ABO and
RhD] and the Expiration Date and Time Data Structures when this information is
available. Any additional ISBT 128 data structures (excluding nationally defined
structures) may also be included.
Where a Data Matrix symbol is used, it should be positioned as close to the bottom of
the label as practical in the lower right quadrant.
Figure 6 shows the placement and nominal size of bar codes on a final label.
1 2
3 4
Gray lines marking quadrants are for reference only and should not be printed on the label
Strongly Recommended
4 – Expiration Date and Time
When encoded in a linear bar code or as standalone information in a 2-D symbol, it shall
be placed in the upper right quadrant.
When encoded along with other product information in a 2-D symbol, the eye-readable
GRID shall be placed in the upper right quadrant, and the 2-D symbol should be
positioned as close to the bottom of the label as practical in the lower right quadrant.
For an example of the GRID in a linear bar code and as standalone information in a 2-D
symbol, see Section 7, Figure 21 and Figure 22.
6 Text
Fonts selected for labels shall allow differentiation between similar characters (e.g., 0/O and
1/I).
Particular font sizes and types are not specified, but designers shall ensure clarity of all text and
use larger fonts to emphasize critical information. The use of color (e.g., for ABO) is neither
prohibited nor encouraged.
Unless otherwise specified, every ISBT 128 linear bar code on a container label shall be
accompanied by text that corresponds to the data content. It shall be printed left justified
immediately below, but not touching, the linear bar code, unless otherwise specified. Text shall
be in font that differentiates similar characters with a maximum height of 2 mm.
At a minimum, data labels (i.e., text indicating the meaning of the data item) should be used
when the purpose of the code is not apparent by its position on the label or by its context, see
Figure 7. Appropriate abbreviations may be used when space is limited.
W1234 17 123456
The flag characters “ff” may be used to convey specific information other than the unique
identification of the product and shall be distinguished from the Donation Identification
Number.
When the default value (00) is used for flag characters, it does not have to be printed.
When Type 1 or Type 2 flag characters are used, they shall be printed as either:
• Numeric Presentation: The two-digit values of flags “ff” shall be printed rotated 90º
clockwise to make them visually different from the Donation Identification Number.
W0000 17 123456 G
Flag Characters
An additional check character is calculated on the thirteen data characters of the DIN. It
is printed enclosed in a box to the right of the DIN and flag characters, see Figure 8. The
check character system ISO/IEC 7064 Mod 37-2 method is used to compute this check
character. The manual check character should be used to ensure the accuracy of
keyboard data entry.
When linear bar codes are used, the DIN shall be printed beneath the corresponding bar
code, but it does not need to be left justified. This allows the DIN to be printed in a larger
font.
6.2 Facility
The name and the address of the facility that corresponds to the Facility Identification
Number (FIN) may appear beneath the DIN in text.
Note: It is also recommended that facilities not publish their FINs on their websites or
other materials in order to keep the link between FIN and facility name less easily
discoverable.
The Class name shall be printed and Attributes (except default Attributes) text should be
printed on the label when space allows. Product description text should be printed with
the Attributes proportionally smaller than the Class name.
Modifiers are no longer used with cellular therapy products. For facilities that have not
moved to the new terminology, please consult version 1.0.0 of this Standard for
instructions on how to print modifiers. For version 1.0.0 of this document, please contact
the ICCBBA office.
On smaller labels, the full product description may not fit on the label. The Class name
or approved abbreviation shall appear. Abbreviations of Class names [described in the
ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002)] may
be used on partial labels if space does not permit the full name and if allowed by
regulatory authorities. If abbreviations are used, the full Class name shall be used in the
accompanying documentation.
If space does not permit, the Attributes may be included on attached labels or in
accompanying documentation. Where space allows, a phrase such as “See Attached
Documentation for Details” should appear when the Attributes are not printed on the
label. Relative size of Class and Attributes should be as described above, if space
permits.
In this situation, it would be appropriate to print a statement on the label such as “Other
Additives Present” and “See Attached Documentation for Details,” see Figure 14.
Figure 14 Printing of “Yes/No” Attributes
6.5 Dates
When bar codes for dates (collection or expiration) are present, the corresponding text
shall be printed in the upper left quadrant for the collection date/time and lower right
quadrant for the expiration date/time. When linear bar codes are present, the information
shall appear beneath the corresponding linear bar code.
If bar codes for dates are not present, text information for collection date/time, if present,
should appear in the upper left quadrant and text information for expiration date/time, if
present, should appear in the lower right quadrant.
Dates shall be printed in compliance with ISO 8601-2004 extended format (YYYY-MM-
DD) or in the format day — month — year. If the latter, the day shall be numerical and
the month alphabetical using a three-letter abbreviation. The year shall be a four-digit
numerical representation.
Times shall be printed based on a twenty-four hour clock with a colon placed between
the hours and minutes.
2018-06-05 15:15
OR
05 JUN 2018 15:15
When the default time of 23:59 is encoded, the time does not have to appear as text,
although it is acceptable if it does appear.
2018-06-05
OR
05 JUN 2018
or
2018-06-05 23:59
OR
05 JUN 2018 23:59
If the product is to be shipped across time zones, AABB and FACT-JACIE Standards
require that the text expiration date and time include the local time zone. In addition, the
ISBT 128 Standard requires that the label also include the Coordinated Universal Time
(abbreviated UTC, previously known as Greenwich Mean Time, or GMT) when the
product is to be shipped across an international time zone.
The UTC shall be printed beneath the local time in parentheses with the designation
“UTC.” Italics may also be used to clearly differentiate UTC from local time. For example:
Expiration Date/Time:
OR
Note: It is recognized that local time zone designations may have little meaning
internationally since two time zones may have the same abbreviation [e.g., CST can be
China Standard Time (UTC+08 hours) or Central Standard Time in North America (UTC-
06 hours)]. However, the Cellular Therapy Coding and Labeling Advisory Group
(CTCLAG) believe that local time zones are more readily interpreted within a continent.
For products shipped to different continents, UTC should be used to interpret time.
The Flexible Date and Time [Data Structure 031] allows the UTC to be encoded. With
the right software, the local date and time can be calculated from the UTC. For additional
information on use, see Implementation Guide: Use of Flexible Date and Time [Data
Structure 031] (IG-024).
If not nationally defined, facilities may add additional text to the label where space
permits and there is a need. While the placement of this information is not standardized,
examples in Chapter 7 provide some suggestions.
Spacing between the blocks shall be sufficient to ensure the blocks are clearly
separated.
The GRID shall be printed in a font that allows differentiation between similar letters and
digits (e.g., 0 and O, 1 and I).
When printed on a product label, the GRID shall be preceded with the uppercase letters
GRID and a colon (i.e., GRID:) and placed in the upper right quadrant. See an example
of the eye-readable GRID in Section 7, Figure 20.
7 Label Examples
The following labels are provided as examples only. National regulations and appropriate
standards must be consulted to ensure full compliance with requirements.
Note: With linear bar codes, there is not enough space to include Attribute text.
Note: With linear bar codes, there is not enough space to include Attribute text.
This label is 38 mm wide x 19 mm high. “Recipient Identification” has been abbreviated “RID.”
8 Glossary
General Terminology Used in ISBT 128 Coding and Labeling
Data Content The characters in a data structure that encode the information for which the
data structure is named. The data content does not include the data
identifier. (The Donation Identification Number is an exception to this rule.)
Data Identifier The first two or three characters in a data structure that identify the data
structure. These will always be present when the data structure is used as a
bar code, but may be omitted when the data structure is used in situations in
which the data structure identity is unambiguously and explicitly defined. [The
Donation Identification Number is an exception to this rule. The second
character of the data identifier can never be dropped because it is also part
of the data content. See ISBT 128 Standard Technical Specification (ST-
001).]
Data Structure Information content comprising the data identifier and data content. When a
data structure is represented as a bar code, the term data structure does not
include the symbology-specific and always present start and stop codes, the
modulo 103 check character, or any specified control characters.
Label An independent entity that may carry one or more bar codes and also
provides eye-readable information about the product.
Affixed Label A label that adheres in physical contact with the product
container.
Partial Label A label that because of size or other constraints does not
contain all the required information.
UTC Coordinated Universal Time, similar to GMT (Greenwich Mean Time), marks
the starting point of every time zone in the World. UTC does not change
based on daylight saving (summer) time; thus, the relationship of local time
to UTC changes if daylight saving (summer) time is observed.
DIN Year A two-character numeric code assigned by the facility that is used to
Code ensure uniqueness of a Donation Identification Number for a period of 100
years.
Flag Character Part of the data content of a data structure used in process control or data
transmission checking. For ISBT 128, flag characters are used with the
Donation Identification Number. Printed in eye-readable format, but
distinguished in some manner from the representation of the other data
characters.
Check Character A character used to ensure the accuracy of data. The value is calculated
based on an algorithm applied to the data. Examples are the modulo 103
check character internal to Code 128 and the ISO/IEC 7064 modulo 37-2
check character appended to text that verifies accurate keyboard entry.
Product Code
S12124A0
Product Description Division
Code Code
Collection Type
Code
Product Code An eight-character ISBT 128 code that comprises the Product Description
Code, a Collection Type Code, and a Division Code. The Product Code
makes each product from a collection unique. This is the Data Content for
the Product Code Data Structure.
Division A two-character code that uniquely identifies multiple products with the
Code same Product Description Code and Donation Identification Number.