Technical Service; Accessories/Replacement Parts; Technical Specifications; Extracts From Relevant Standards - B.Braun AESCULAP Sistema de contenedores estériles Instrucciones De Manejo

8. Technical Service

For service, maintenance or repairs, please contact your national B. Braun/
Aesculap agency.
All guarantees and warranty rights as well as licenses will be void if
modifications on the device are performed.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 7461 95-2700
Fax: +49 7461 16-2887
E-mail: ats@aesculap.de
Other service addresses can be obtained from the address indicated above.

9. Accessories/Replacement parts

Accessories and expendables are listed in brochure no. C40401.

10. Technical specifications

The range of models and sizes of sterile containers is listed in brochure no.
C40401.

11. Extracts from relevant standards

11.1 Quoted standards

The following standards are quoted in connection with the sterile
containers:
• DIN 58953-9
• DIN 58946-1, EN 285, EN 866-3
• EN 868-1, EN 868-8
• EN 285/ANSI/AAMI/ISO 11134-1993, ANSI/AAMI ST46-1993,
further applicable EN ISO 17665 or EN 554/ISO 13683
• EN ISO 11607
11.2 Storage period for sterile materials —
extract from DIN 58953-9, sterile supplies
Loss of sterility is less likely caused by excessive storage periods as by
external influences and impacts during storage, transport and handling.
Therefore, there can be no general statement concerning appropriate
storage periods. The appropriate length of storage periods is determined
by the hygiene control committee. Responsibility for storage conditions
and storage periods lies with the hospital's operator or its medical
director.
Where appropriate, different storage periods for individual department
should be laid down in writing, also taking account of the type of
packaging and the storage conditions.
Recommended storage period for sterile materials in sterile
containers
according to EN 868-1 and EN 868-8: 6 months
The storage period just quoted represents a recommendation that, if
followed, would limit the risk of contamination during transport and
opening of the sterile container. Storage for longer periods can lead to
contamination of outer surfaces, depending upon storage conditions.
Although such longer periods do not in and of themselves lead to
recontamination of the contents of the package during storage, they do
increase the risk of contamination when sterile containers are transported
or opened. The recommended storage period is based on storage under dry
and dust-protected conditions. Longer storage periods are possible under
appropriate conditions at the storage site.
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