Healthpack’09
Memphis, TN
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E Labeling (lack of) progress in the EU
The new (14 Jan 2009) ISO 28219:2009, Packaging -Labeling and direct product marking with linear bar code and
two-dimensional symbols
EN 980 Symbols for use in the labeling of medical devices and
EN1041-Information supplied by the manufacturer of medical
devices; updates in 2008
Survey results: Preliminary work on a guidance doc for the
pressure sensitive labeling of terminally sterilized medical
devices.
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“In the light of technical progress in information technology and
medical devices, a process should be provided to allow information
supplied by the manufacturer to be available by other means”.
Amendment to Article 11…..the following paragraph is added:
“14. The Commission may, in accordance with the procedure
referred to in Article 7(2), adopt measures allowing instructions for
use to be provided by other means.”
Pretty much nothing has happened
since last years update...
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Updated MDD no longer expressly prohibits E Labeling.
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Proposed MDD acceptance may occur sometime this century.
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Asia – Move toward E Labeling, CD ROM widely accepted.
Japan modeling requirements after EU; Hong Kong has
accepted E Labeling
Eucomed and Global Harmonization task force have come up
with guidelines for safe and effective labeling
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Countries can still individually dictate how they will accept IFU’s;
with the acceptance of Bulgaria and Romania there are now 23
recognized European languages.
Consult with your notified body to see if your product is eligible
for E labeling in a specific country.
Pay close attention to rev control, access, proof of delivery,
language requirements, security, etc.
CD’s with product has generally been acceptable with notified
bodies.
Research specifics for your device in each regulated region you
are going to distribute in and be aware of ‘nuances’.
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Pertains to labels with barcodes only
is intended to “include, but it is not limited to,
multiple industries” including healthcare
manufacturers.
Defines minimum requirements for identifying items.
Provides guidelines for item marking with machinereadable symbols.
Covers both label and direct marking of items.
Includes testing procedures for label adhesive
characteristics and mark durability.
Provides guidance for the formatting on the label of
data presented in linear bar code, two-dimensional
symbol or human readable form
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Revised in 2008 – symbols “deemed suitable
without need for further explanation”.
Expanded from 12 to 29 symbols; 10 new EN
980 symbols and 7 from ISO 15223
Manufactures can still create their own
symbols as long as they are described in the
IFU
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First change in 10 years, although not much
has really changed
Annex A is the useful part, similar to the EN
980 symbol library.
Does clarify that full postal addresses are not
needed, just enough so the physical location
of the manufacturer is apparent; PO box is no
good.
Annex B discusses alternate labeling and elabeling.
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The Labeling Task Group put together a 10
question survey on Label Testing Methods &
Practices.
Summary to follow………….
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80% - yes
20% - no
Comments:
We evaluate our label as part of our packaging transit
qualification testing.
Originally completed, have not changed in years to require
evaluation.
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Yes, specific criteria and pre-defined acceptance –
80%
No, not specifically noted or tested – 20%
 60%
- yes
 40% - no
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60% - yes
40% - no
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Comments to “in general, what have you learned ‘the hard way’?”
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1.adhesion to specific substrates and temperature and humidity
conditioning equal or above that tested for the final product
2. ink rub test is an objective method to compare ink adhesion.
3.Readability of barcodes after smudge test
4.Be careful with DOE work to ensure product labels will remain
legible in shelf life testing.
5.Tamper evident seals falling off.
6."Kiss-cut" vs. "Perf-cut" on label sets. For certain applications the
kiss-cut allowed labels to peel up or peel completely off the package
prior to point of use. This type of background is very relevant and
valuable when evaluating new label set stocks.
7.Ribbon performance verses cost and maintenance
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ASTM D4169, Distribution simulation – 85.7%
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ISTA Distribution simulation practices – 28.6%
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ASTM F1980, Accelerated aging - 92.9%
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TAPPI methods – 7.1%
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UV exposure or other "fading" method – 0%
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1.No
2.Yes. 6 day conditioning. 2 days @ 95 degrees/95%RH , 2
days @ 135 degrees/25%RH, 2 days at -30 degrees. 3.RH
is controlled.
4.No Humidity. We do specify environmental conditioning
that includes Freeze/Thaw as part of our test protocols.
5.Typically, humidity is held at less than 20% in our AA
protocols.
6.We use ambient for humidity
7.Yes.
*continued next slide*
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8.Yes, but only based on Product requirements. AM
9.yes.
10.There is a "freeze/thaw" conditioning step used fro
time zero testing. Humidity is controlled at <20% which is
the default humidity used by the testing facility and
relevant standards.
11.no and no
12.No, unless substrates are paper... then Yes.
13.We monitor humidity level; typically less than 20%
is good; 11% is ideal We do not use Freeze/Thaw
cycles
14.No freeze thaw. Humidity controlled at high
temperature and 'non-condensing' humidity used at
low temperature
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Pre-sterilization - 46.7%
After a defined period of time - 46.7%
Post-sterilization - 73.3%
Post-distribution - 86.7%
After several pre-defined conditioning events
-13.3%
At more than one conditioning milestone
-26.7%
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Varies by feature or aspect - 33.3%
100% inspection or testing - 13.3%
Sample size determined by statistical method-66.7%
Fixed sample size (ex. n=30) - 33.3%
Comment: each lot of printed labels is inspected as a
unit. The lot is spot-checked for smudges, accuracy
of content, and general legibility. 100% of printed lots
are inspected.
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ASTM D3330, Peel adhesion of PS material - 20.0%
ASTM D5264, Sutherland abrasion and smudge
resistance test - 20.0%
ASTM F1319, Crockmeter abrasion and smudge
resistance test 0.0%
ASTM F2252, Ink adhesion tape test - 6.7%
(CEN/CENELEC) EN45502-, General Requirements for
marking - 6.7%1
Visual inspection (legibility) - 93.3%
Internal corporate standard - 20.0%3
"Simple" performance such as corner flagging - 26.7%
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Yes – 13.3%
No - 60%
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Other (comments)
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depends on the application/purpose of the label
We inspect for corner peeling and label tearing.
no, it is a part of the peel test failure modes
Simple tear testing is employed.
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This information will be posted on the IOPP
Medical Device Technical Committee’s
Labeling Task Group link.
http://www.iopp.org/i4a/pages/index.cfm?p
ageid=363
Please direct comments and questions to
Dave Olson, 612.706.3742
[email protected]
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Dave Olson, Advanced Web - Chair
Mark Andersen, BSCI
Ryan Cannon, American Medical Systems
Jan Gates, Abbot Vascular Cardiac Therapy
Gerry Gunderson, Quality Tech Services
Laurie Jordan, Smith Nephew
Susan Ritter, Tyco Healthcare/Valleylab
Judy Salzer, Medtronic CRDM
Dan Schaefer, Zimmer Spine
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Labeling Task Group Update