4-1
Techniques of Sterilisation Operator Manual P129390-106
4.1 General The information in this section is intended as a general guide to
steam sterilization techniques. Also recommended is reference to
the standards of the EN 285:2006, Sterilization – Steam Sterilizers,
Large Steam Sterilizers EN ISO 17665-1:2006, Sterilization of
Healthcare Products – Moist Heat Part 1: Requirements for the
development, validation and routine control of a sterilization process
for medical devices
• Prior to sterilization, all materials and articles must be thoroughly
cleaned.
• After sterilization, goods should be stored in conditions that will
not compromise the barrier quality of their wrapping materials.
Training for all personnel on the operation and the maintenance of
the sterilizer shall be performed on a regular basis. Records of this
training and evidence of the understanding of the training material
shall be maintained, and are the responsibility of, the organization or
facility where this equipment is in use.
Important: Applicable cycles have been validated to satisfy the
requirements outlined in Table 4-1 (page 4-2). If cycle parameters
(sterilize time, dry time, temperature) other than those listed are
required, it is the responsibility of the healthcare facility to validate
the cycle. Reference EN ISO 17665-1:2006, Sterilization of
Healthcare Products – Moist Heat for guidelines and standards for
validating sterilization cycles and ensuring that proper sterility
assurance level (SAL) as well as moisture retention acceptance
criteria are met.
NOTE: Contact STERIS for information on a wide range of education/
training programs designed to meet the educational needs of
healthcare industries.
WARNING: It is inappropriate
for a healthcare facility to
sterilize liquids for direct
patient contact.
TECHNIQUES OF STERILIZATION
4
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