YY/T 1623-2018Test method of effectiveness of sterilization processes for reusable medical devices (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies test methods of determining the effectiveness of sterilization process for reusable medical devices.

This standard applies to tests that have established the effectiveness of the sterilization process, it does not apply to the validation of the sterilization process.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.

GB/T 6682 Water for analytical laboratory use - Specification and test methods

GB 18281.2 Sterilization of health care products-Biological indicators - Part

3 Biological indicators for moist heat sterilization processes

GB 18281.4 Sterilization of health care products - Biological indicators - Part

4 Biological indicators for dry heat sterilization processes

The Pharmacopoeia of the People's Republic of China (2015 version), volume IV

4.3 After the sample has been processed through a complete sterilization process, it shall use a specific elution technique to recover all residual bacterial spores from the device.

4.4 Use a minimum 5 devices to perform a process test cycle, or otherwise use one device to perform at least 5 consecutive process test cycles. If they are all qualified, this sterilization process is valid.

4.5 The person conducting this standard testing shall have an educational background in microbiology or related professional knowledge.

4.6 The sterility inspection and microbial limit inspection shall comply with the corresponding requirements of the Pharmacopoeia of the People's Republic of China (2015 version), volume IV.

5 Test devices

It shall include at least the following devices.

a) Sterile cotton-swabs;

b) Pressure steam sterilizer;

c) (48 ± 2) °C constant-temperature water-bath;

d) (35 ± 2) °C and (55 ± 2) °C bacteria incubator;

e) A disposable or reusable sterile membrane filter which has a 0.45 µm pore size;

f) Other devices or equipment as specified by the manufacturer of the sterilant, medical device or sterilizer.

6 Reagents

7 Procedures

7.1 Select the devices which require evaluation.

7.2 Read the cleaning instructions for the devices which require evaluation, ensure that all required accessories are complete and available. Follow the manufacturer's instructions to wash and dry the devices.

7.3 Infect the device, the infected part shall include the part of device which is most difficult to sterilize. The number of infected parts shall be determined based on the complexity of the device. The rationale for identifying and proving the parts of the device which are most difficult to sterilize shall be documented.

7.4 For procedures for contamination, elution, control testing, neutralization, growth promotion (sensitivity testing) and process testing cycles, the laboratory shall perform validation and develop standard operating practices.