FDA审批 医疗器械 湿热灭菌确认方案

Sterilization Validation Protocol

Device name: XXXX

Model: XXXX

Sterilization condition: Gravity steam, 134℃for 10 minutes

Test parts: XXXX

Prepared by: ________________ Audited by: ________________ Title: RA Engineer Title: Management representative

1.General information

Protocol No.: XXXX-01

Sponsor: XXXX Limited.

Add: XXXX China.

Test personal :XXX

Test objective: To Validate the sterilization efficacy of XXXX when processed in a hospital steam gravity cycles: 273℉（134℃）for ten (10) minutes exposure.

Test sample: XXXX, see table 1.

Test Lab:XXXX Limited

Microbiological

Testing laboratory：XXXX LTD (Registration ID: CNASXXXX)

Reference:

1)Pflug, IJ, and Holcomb, RG, “Principles of the Thermal Destruction of Microorganisms” in Disinfection,

Sterilization and Preservation, (SS Block, ed). Lea & Febiger, Philadelphia, 4th edition, 1991.

2)United States Pharmacopeia. Current Edition.

3)ANSI/AAMI ST55:2013, Table top steam sterilizers.

4)ANSI/AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in

health care facilities: A guide for device manufacturers.

5)AAMI/ISO 14937:2009 Sterilization of health care products –General requirements for

characterization of a sterilizing agent and the development, validation and routine control of a

sterilization process for medical devices.

6)ANSI/AAMI ST81: 2004 (R2010) Sterilization of medical devices –Information to be provided by

the manufacturer for the processing of resterilizable medical devices.

7)ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (Consolidated Text) Comprehensive guide to steam

sterilization and sterility assurance in health care facilities.

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

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

9)XXXX instructions: User manual.

2. Introduction

This protocol details the methods to be used in determining the sterilization cycle of XXXX when processed in a gravity steam sterilization cycle of 273℉（134℃）for ten (10) minutes exposure. A method of steam sterilization was utilized in order to achieve a sterility assurance level (SAL) of 1.0×10-6 using the biological indicator (BI) overkill method. The SAL was achieved by placing a minimum of 1.0×106 spores of Geobacillus stearothermophilus and processing at one-half the excepted full cycle exposure time. Following exposure, BI will be sent to external certification body (XXXX LTD) for incubation.

A total of three (3) testing cycles will be performed.

3. JUSTIFICATION

The overkill method was selected to verify the sterilization efficacy of the devices per AAMI/ISO guidelines. In this method , validation is accomplished by demonstrating that a minimum of 10×106 highly resistant Geobacillus stearothermophilus spores will be killed in a half-cycle (6-log reduction). A full cycle would therefore result in a 12-log reduction of spores and produce a 10-6 SAL, which reflects a one-in-a-million chance of a non-sterile item. The study provide the sterilization efficacy data for the product.

4. EQUIPMENT AND MATERIALS

1)XXXXs: XXXX

2)Lubricant: Mineral Oil based spray

3)Sterilizer: Table top steam sterilizer

4)Sterilization pouches

5)Test organism(BI): Geobacillus stearothermophilus ATCC 7953 biological indicator (BI) spore

strips.

6)Steam integrators (CI): Class 5 Integrators

5 Sterilization

5.1 Gravity Steam Half-cycle description

Temperature : 134℃（273℉）; Exposure Time: 5mins.

5.2 Validation of spore

The biological indicators selected for testing will be chosen for use based on the listed population, D-value,