CLASSIC MEDICAL TECH(SHA)CO.,LTO CE technology document
Document ‘s Serial number：PR050108 status：1.1
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Description of sterilization process
1 General
1.1 Objective
According to requirements of EN 550-1994《Medical Device — EO sterilization validation and
routine control》，validate (verify) the validity of EO sterilizer to ensure the requirement of medical
device for single use.
1.2 scope
This validation protocol is only applicable for validation on Model HDX10 EO sterilizer produced
by Hangzhou Dianda Disinfection Equipment Factory.
1.3 Method
Half-cycle method.
1.4 Validation
1.4.1 Validation protocol：the validation protocol was established by validation team of the company,
and approved by management representative before implementation.
1.4.2 Implementation of validation：The validation team was composed by related personnel from
responsible departments, which is responsible for the implementation of EO sterilization according to
validation protocol.
1.4.3 Validation result：Confirm the result according to data obtained from validation process by
participants, which shall be concluded and signed.
1.4.4 Validation data：All validation data, materials collected and validation reports shall be retained and
archived well.
1.5 Requirements
Data collected in validation shall be accurate and valid, and shall be conforming to specifications
of EN 550-1994 《Medical device — EO sterilization validation and routine control》.
2 Validation protocol
2.1 Physical performance validation
2.1.1 Evacuation rate test
Requirement：pre-evacuate to —15Kpa with time ≤6min；
Pre-evacuate to —50Kpa with time ≤30min；
CLASSIC MEDICAL TECH(SHA)CO.,LTO CE technology document
Document ‘s Serial number：PR050108 status：1.1
Page 2 of 8
Condition：Temperature— constant.
2.1.2 Evacuation leakage test
Requirement：pre-evacuate to —— —50Kpa；
Leakage rate ≤0.1KPa/min.
Condition：Temperature — Constant；