Cleaning Validation Protocol
Device name: XXXX
Model: XXXX
Test parts: XXXX
NO. | Name | Position | 犹如的反义词我要向前飞 Speciality |
1 | | 劳动课RA Engineer/team member | Major: Biotechnology, Understand cleaning requirements |
2 | | Mechanical Engineer/team member | Familiar with Dental XXXXs |
3 | | Quality manager/team member | Profession in Quality Management |
4 | | Management Reprentative/test director | Provide the resource support |
| | | |
小松鼠采松果
Title: RA Engineer
Title: Management reprentative1.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 ur manual for XXXX.
Test sample: XXXX, e 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 Process, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices.
鲁迅父亲的病Alfa MJ, Degagne P, Olson N. Worst-ca soiling levels for patient ud 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
Ur manual of XXXX
2.Introduction
This protocol details the methods to be ud 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 tho considered to be most challenging to clean and most likely to be soiled during actual u. The device then will be procesd in accordance with the cleaning procedure delineated in ction 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.
3.JUSTIFICATION
This test method was bad on methods outlined in AAMI TIR30:2011 and ASTM D7225-
媲美的近义词
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 ud to inoculate the device will simulate worst ca contaminants (blood and human saliva) that may come in contact with the device and remain on the device after clinical u. 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 u. The least effective (lowest) cleaning temperatures (according to the using temperature) within recommendations etc. The procedures will provide worst ca soiling conditions for the cleaning validation.
Acceptance criteria : no obvious stain under visual Obrvation, and will be bad on study data of residual blood levels of properly cleaned medical instruments which indicate that after cleaning, the level of blood < 0.1 g/deviceon 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, ud for blood Analysis
6)Swab
7)Timer
8)Thermometer
9)Soft cloth
10)soft brush
5.Cleaning
5.1Preparation of artificial test soil
The artificial test soil will contain the following components to mimic blood and saliva:
2.5 ml rabbit blood
2.5 ml physiological saline
5 ml human saliva
罗曼罗兰简介
5.2Cleaning validation Procedure
1)The devices listed in Table 1 will be obtained. See Table 2 for testing sample sizes.
2)Prior to testing, all devices will be pre-cleaned following steps 5).
3)The test samples will be inoculated in the most difficult to clean locations and areas most likely to be soiled during actual u with the prepared artificial test soil, e Figure 1 for the device inoculation description.
4)The inoculated test samples will be allowed to dry at room temperature for a minimum of two (2) hours to simulate worst ca conditions. A photo of the soiled devices will be included in the final report.
5)Head cleaning (for Each test sample and negative control):
a.Remove dirt and debris from the water spray outlets with a soft brush,
英文祝福b.Fill a cup halfway with clean water,
