FDA 审批 医疗器械 清洁验证方案

Cleaning Validation Protocol

Device name:

XXXX

Model: XXXX

Test parts: XXXX

NO.

1

2

3

4

Name

Position

RA Engineer/team member

Mechanical Engineer/team

member

Management

Representative/test director

Speciality

Major: Biotechnology, Understand cleaning

requirements

Familiar with Dental XXXXs

Quality manager/team member

Profession in Quality Management

Provide the resource support

Prepared by: ________________

Audited by: ________________

Title: RA Engineer

Title: Management representative

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1. General information

Protocol No.:

XXX-01

Sponsor:

XXXX Limited.

Add: XXXX China.

Test director:

XXX

Test personal

:

XXX

Test objective:

Validate the efficacy of cleaning method (manual cleaning) provided in user manual for

XXXX.

Test sample:

XXXX, see table 1

Test Lab:

XXXX Limited

Reference:

?

AAMI TIR12:2010 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in

Health Care Facilities. A Guide for Device Manufacturers 1st ed.

?

AAMI TIR30:2011 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for

Cleaning Reusable Medical Devices.

?

Alfa MJ, Degagne P, Olson N. Worst-case soiling levels for patient used flexible endoscopes before and

after cleaning. Am J Infect Control 1999;27:392-401.

?

ASTM D7225-13 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer- disinfectors

?

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for

Industry and Food and Drug Administration Staff. March 17, 2015

?

User manual of XXXX

2. Introduction

This protocol details the methods to be used to validate the effectiveness of a manual cleaning procedure for

the XXXX.

The device will be inoculated with an artificial test soil in various areas including those considered to be

most challenging to clean and most likely to be soiled during actual use. The device then will be processed in

accordance with the cleaning procedure delineated in section 5. the device will be assayed and residual blood

will be recovered to determine if adequate cleaning was achieved.

This testing will be repeated for a total of three (3) test cycles.

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3. JUSTIFICATION

This test method was based on methods outlined in AAMI TIR30:2011 and ASTM D7225-13 .Cleaning

instructions for reusable medical devices require validation in order to assure proper and safe reprocessing of

the devices by health care facilities. It is well known that a device which has not been cleaned properly may

inhibit the ability of the sterilization process to achieve the proper sterility assurance level. This cleaning

procedure must be able to remove gross amounts of soil from the test device in order for it to be determined

clean and safe for further processing. This study will attempt to verify that gross amounts of soil can be

removed from the device following the recommended cleaning procedure.

The artificial test soil used to inoculate the device will simulate worst case contaminants (blood and human

saliva) that may come in contact with the device and remain on the device after clinical use. The device will

be soiled using the artificial test soil and inoculated in the most difficult to clean locations and areas most

likely to be soiled during actual use. The least effective (lowest) cleaning temperatures (according to the

using temperature) within recommendations etc. These procedures will provide worst case soiling conditions

for the cleaning validation.

Acceptance criteria

: no obvious stain under visual Observation, and will be based on study data of residual

blood levels of properly cleaned medical instruments which indicate that after cleaning, the level of blood

＜

0.1 ?

g/device

on the device after performing the recommended cleaning procedure will indicate adequate

cleaning and demonstrate that the cleaning method is efficacious in removing soil .

4. EQUIPMENT AND MATERIALS

1)

XXXX: XXXX

2)

Detergent: 75% alcohol

3)

Rabbit blood

4)

Human saliva

5)

Solution 1--0.1%Tetramethylbenzidine (TMB) in 5% acetic acid, solution 2--3% hydrogen

peroxide solution, used for blood Analysis

6)

Swab

7)

Timer

8)

Thermometer

9)

Soft cloth

10)

soft brush

5. Cleaning

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