eResearchTechnology GmbH AM3G01 Manuale Utente
Page 36/42
Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
The following applies for products which are potentially contaminated by
biological working substances of risk group 3 and 2 according to the regulation on
biological substances and which are thus classified as Transport Category B:
Please contact ERT before returning the goods and refer to the regulations for the
transport of dangerous goods.
biological working substances of risk group 3 and 2 according to the regulation on
biological substances and which are thus classified as Transport Category B:
Please contact ERT before returning the goods and refer to the regulations for the
transport of dangerous goods.
2. Cleaning
If the products had contact with biological working substances (for example blood
or other body fluids), they have to be cleaned and disinfected in a combined
cleaning and disinfection procedure, unless a differing agreement has been made
with ERT.
As a rule, the products also have to be cleaned in order to minimize adhesions and
bacterial contamination. Unless body fluids, body tissue or contrast agents etc.
have caused the product defective, deposits and adhesions should be removed
carefully without damaging or altering the product, if possible. For this, refer to
the notes on the preparation of products.
Products which have been contaminated by highly active pharmaceuticals have to
be cleaned appropriately with tap water.
If the products had contact with biological working substances (for example blood
or other body fluids), they have to be cleaned and disinfected in a combined
cleaning and disinfection procedure, unless a differing agreement has been made
with ERT.
As a rule, the products also have to be cleaned in order to minimize adhesions and
bacterial contamination. Unless body fluids, body tissue or contrast agents etc.
have caused the product defective, deposits and adhesions should be removed
carefully without damaging or altering the product, if possible. For this, refer to
the notes on the preparation of products.
Products which have been contaminated by highly active pharmaceuticals have to
be cleaned appropriately with tap water.
If in doubt, contact ERT for guidance on the further actions!
3. Disinfection/Sterilization
After cleaning, the products have to be disinfected and/or sterilized (only if
permitted for this medical product) in order to avoid endangering of your and our
employees.
If in doubt or in case of suspected material incompatibility, please consult ERT.
After cleaning, the products have to be disinfected and/or sterilized (only if
permitted for this medical product) in order to avoid endangering of your and our
employees.
If in doubt or in case of suspected material incompatibility, please consult ERT.
4. Packaging
To avoid any contamination, the cleaned and disinfected product has to be packed
as follows:
a) Put it into a sealable primary packing.
To avoid any contamination, the cleaned and disinfected product has to be packed
as follows:
a) Put it into a sealable primary packing.
Parts with sharp edges need to be packed particularly safely.
b) Put the primary packing in a waterproof secondary packing (if possible use
hard packing material).
c) Pack the secondary packing with a neutral packing material.
For “Packaging and labeling of non-contaminated products“: see point 6.
hard packing material).
c) Pack the secondary packing with a neutral packing material.
For “Packaging and labeling of non-contaminated products“: see point 6.