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Section 1
Page 6
1.4

Definitions of Terms

Term
Disinfection
German Society for Sterile
Supply (Deutsche Gesell-
schaft für Sterilgutversorgung
e.V.)
Specialist
Gastronorm
H1
ISO Standard
Check, inspect
Machine safety
German Law on Medical
Devices (Medizinproduk-
tegesetz)
Passive layer
Verify, test
Qualified person,
qualified personnel
Clean / unclean side
Sterile supply
Sterilisation unit
Serving Trolley
SW | SW ERGO | SSW | SSW ERGO | MSW | MSSW
Definition
Reduction of causal agents of infections on and in contaminated objects, so that the
objects can no longer be the source of further infections.
The primary objective is to create a uniformly high standard of quality in the preparation
of medical devices. The recommendations of the Quality Committee of Experts provide
tips and instructions on practical methods of preparation. For instance, the introduction
of agreed curricula for training personnel entrusted with preparing medical devices
made it possible to implement recognised standards that have made a significant
contribution towards achieving the stated objectives.
A specialist is a person who can assess work assigned and can recognise possible
hazards themselves based on their professional training, skills, experience and
knowledge of the respective guidelines.
Gastronorm is a measurement system used worldwide in places such as food pro-
cessing plants or large-scale kitchens. The use of standardised sizes makes it possible
to exchange food pans. The basic size of the Gastronorm (GN) 1/1 is 12.8 x 20.9'' (325
× 530mm). Items are available in different depths.
Hygienic standard (NSF/USDA) for lubricants that are suitable for incidental and tech-
nically unavoidable contact with foodstuffs
The ISO standard is a system of measurements governing containers used in sterile
supply logistics, for example, for transport and storage of articles in cupboards and
transport vehicles, in OP theatres, ambulances, preparation and ward rooms as well as
laundry rooms. The basic dimension is 15.7 x 23.6'' (400 x 600 mm). ISO standard
containers are available in different versions and with different depths.
Compare with certain conditions and/or characteristics such as damage, leaks, filling
levels and heat.
The term machine safety refers to all the measures used to avert injury to persons. The
basis for machine safety is directives and laws for protecting users of technical devices
and systems valid nationally and across the EC.
The German law governing medical devices is the name given in Germany and Austria
to the transposition into national law of the European Directives 90/385/EEC relating to
Active Implantable Medical Devices, 93/42/EEC relating to Medical Devices and
98/79/EEC relating to In-Vitro Diagnostic Medical Devices.
Medicines are not covered by the term medical devices.
A non-metallic protective layer on a metallic material that prevents or slows down
material corrosion.
Compare with certain values such as weight, torque, content or temperature.
Qualified personnel are persons who due to their professional training, experience,
instruction and their knowledge of relevant standards, guidelines, accident prevention
regulations and operating conditions have been authorised by a person responsible for
system safety to carry out required activities and can recognise and prevent any poten-
tial hazards (definition of specialists according to IEC 364).
The Central Sterile Supply consists of three working areas: the unclean side or clean-
ing zone, the clean side (packaging stations) and the sterile area (sterile supply store).
Contaminated material is cleaned and/or disinfected manually and automatically on the
unclean side. Cleaning and disinfecting machines clean, disinfect and dry the material.
Cleaning and disinfecting machines are so-called through-loading types that can only
be loaded on the unclean side and unloaded on the clean side.
The clean side is the second largest working area of the ZSVA (Central Sterile Supply).
The cleaned and disinfected material is then packaged in containers and subsequently
sterilised.
Sterile supply is a historical term that has developed over time in conjunction with the
term sterilisation unit. This volume measurement of 54 l denotes the volume to be
sterilised, in which it is possible to store a different number of medical devices. It is only
of limited use as a measure of performance for the scale of sterilisation of medical
devices.
Volume unit. A sterilisation unit measuring 23.6 x 11.8 x 11.8'' (60 × 30 × 30) cm, which
equals a volume of 54 l.
Introduction
Definitions of Terms
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