eResearchTechnology GmbH AM3G01 User Manual
Page 37/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
5. Labeling
If a concrete risk of infection (e.g. HIV, Hepatitis B or C) is known to be present,
this risk has to be noted on the packing of the returned goods and/or in the
accom-panying documents.
For “Packaging and labeling of non-contaminated products“: see point 6.
If a concrete risk of infection (e.g. HIV, Hepatitis B or C) is known to be present,
this risk has to be noted on the packing of the returned goods and/or in the
accom-panying documents.
For “Packaging and labeling of non-contaminated products“: see point 6.
6. Packaging and labeling of non-contaminated products
If the procedures described under point 2 and 3 are not applied, the contaminated
product has to be returned in a combined packing complying with the packaging
instruction P 650 ADR after contacting ERT, if necessary. Proceed as follows:
If the procedures described under point 2 and 3 are not applied, the contaminated
product has to be returned in a combined packing complying with the packaging
instruction P 650 ADR after contacting ERT, if necessary. Proceed as follows:
a) Put the product into a liquid-tight, sealable packing (e.g. tear-proof plastic
bag) (primary packing)
b) Put the primary packing into a (if possible, liquid-tight) protective packing
(secondary packing); for liquid materials, insert an adequate amount of
absorbing material between the primary and the secondary packing.
c) Pack the secondary packing with an additional outer packaging (padded
envelope or cardboard box).
d) Label the outer packaging with the corresponding UN no. 3373 for
diagnostic or clinical samples and add the note:
bag) (primary packing)
b) Put the primary packing into a (if possible, liquid-tight) protective packing
(secondary packing); for liquid materials, insert an adequate amount of
absorbing material between the primary and the secondary packing.
c) Pack the secondary packing with an additional outer packaging (padded
envelope or cardboard box).
d) Label the outer packaging with the corresponding UN no. 3373 for
diagnostic or clinical samples and add the note:
“Biologischer Stoff, Kategorie B/Biological Substance, Category B“
7. Dispatch
Please note that non-decontaminated returns with suspected pathogens of risk
group 3 are excluded from mailing. Diagnostic or clinical samples of UN no. 3373
which have been packed according to packing instruction P 650 are not subject
to any further regulations on the transportation of dangerous goods and may be
transported by a forwarding agent or a parcel service.
For this purpose use the accompanying shipping documents of the forwarding
agent/carrier containing the corresponding valid transportation regulations, e.g.
GGVSE (Road and Railway Dangerous Goods Regulation).
The product is then dispatched to the address provided by the manufacturer.
Please note that non-decontaminated returns with suspected pathogens of risk
group 3 are excluded from mailing. Diagnostic or clinical samples of UN no. 3373
which have been packed according to packing instruction P 650 are not subject
to any further regulations on the transportation of dangerous goods and may be
transported by a forwarding agent or a parcel service.
For this purpose use the accompanying shipping documents of the forwarding
agent/carrier containing the corresponding valid transportation regulations, e.g.
GGVSE (Road and Railway Dangerous Goods Regulation).
The product is then dispatched to the address provided by the manufacturer.
Address:
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
Tel: +49 9305 720-9891
www.ert.com
eResearchTechnology GmbH
Sieboldstrasse 3
97230 Estenfeld, Germany
Tel: +49 9305 720-9891
www.ert.com