Getinge HS 6613 ER-2 - Test Articles and Spare Parts

38 - OPERATION
Packaging material for formaldehyde
For formaldehyde sterilizing, we recommend paper/plastic bags
intended for steam sterilizing.
Articles for test purposes
The user is responsible for maintaining a routine check of the operation
of the sterilizer in accordance with European standard EN17665. There
are various types of test articles on the market to assist the user.
Chemical indicators
Chemical indicators used when testing various types of sterilizer must
conform to European standard EN867-1, the other parts of which also
specify particular requirements for different types of indicator.
Getinge AB recommends using chemical indicators in steam steriliza-
tion processes. For other types of processes it the user’s responsibility
to evaluate whether individual makes are applicable to the GETINGE
sterilizer process.
An established test method in which chemical indicators are used is the
Bowie-Dick test, with test packages or its equivalent with a disposable
package. For information see also under “Bowie-Dick testing”.
Biological indicators
Biological indicators used when testing various types of sterilizer must
conform to European standard EN866-1, the other parts of which also
specify particular requirements for different types of indicator.
Getinge AB recommends using biological indicators in steam steriliza-
tion processes. For other types of processes it the user’s responsibility
to evaluate whether individual makes are applicable to the GETINGE
sterilizer process.
Sterilizer parts for periodic replacement
Spare parts
So that correct operation and product safety can be guaranteed, parts for
recorders, printers or periodic maintenance must be genuine GETINGE
spare parts or parts approved by Getinge Infection Control. Article
numbers of genuine parts are stated in the relevant sections of the serv-
ice manual.
Sterilization media for low-temperature sterilising with
formaldehyde sterilizers
Low-temperature sterilizing can only be done with special sterilizers
intended for the purpose. During sterilizing with formaldehyde, the
medium is added from containers attached to the sterilizer.
Formaldehyde solution
Containers holding formaldehyde solution are brought to the site and
attached to the sterilizer by the operator.