GB / ISO :2006

Transcription

1 Translated English of Chinese Standard: GB ICS C 47 NATIONAL STANDARD OF THE PEOPLE'S REPUBLIC OF CHINA GB / ISO :2006 Partly replacing GB Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO :2006, IDT) Issued on: December 31, 2015 Implemented on: July 1, 2017 Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of the People's Republic of China. Page 1 of 86

2 Table of Contents Foreword... 3 Introduction Scope Normative references Abbreviations, terms and definitions Definition and maintenance of product families for dose setting, dose substantiation and sterilization dose auditing Selection and testing of product for establishing and verifying the sterilization dose Methods of dose establishment Method 1: Dose setting using bioburden information Method 2: Dose setting using fraction positive information from incremental dosing to determine an extrapolation factor Method VD max - Substantiation of 25 kgy or 15 kgy as the sterilization dose Auditing sterilization dose Worked examples Bibliography Page 2 of 86

3 Foreword All technical content of this Part of GB is mandatory. GB consists of the following parts, under the general title Sterilization of health care products - Biological indicators: - GB Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; - GB Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; - GB/T Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects. This Part is Part 2 of GB This Part is drafted in accordance with the rules given in GB/T This Part partly replaces GB Sterilization of health care products - Requirement for validation and routine control - Radiation sterilization. Compared with GB , this Part was developed from Annex B of GB , main technical changes in this Part are as follows: - ADD the definition of product families; - DETAIL the methods of dose establishment; INTRODUCE the application of Method 1 and Method 2 in detail; - ADD the VD max method. This Part uses translation method to identically adopt ISO :2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. Corresponding Chinese documents of the international document in the normative reference of this Part are as follows: - GB/T Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO :1994, IDT); - GB/T Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO :1998, IDT) Page 3 of 86

4 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose 1 Scope This Part of GB specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kgy or 15 kgy as the sterilization dose to achieve a sterility assurance level, SAL, of This Part also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. This Part defines product families for dose establishment and dose auditing. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO :2006, IDT) ISO Sterilization of medical devices - Microbiological methods - Part 1: Determination of the population of microorganisms on product ISO Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility performed in the validation of a sterilization process 3 Abbreviations, terms and definitions For purposes of this document, the terms and definitions given in ISO and the following apply. 3.1 Abbreviations A Page 7 of 86

5 Bibliography [1] GB Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization [2] GB/T Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects [3] ISO/TS 11139:2006 Sterilization of health care products - Vocabulary [4] AAMI Recommended Practice, RS:1984, Process control guidelines for gamma radiation sterilization of medical devices. Arlington VA, AAMI, [5] AAMI TIR27:2001, Sterilization of Health Care Products - Radiation Sterilization - Substantiation of 25 kgy as a Sterilization Dose - Method VD max, Arlington VA, AAMI, [6] ANSI/AAMI ST32:1991, second edition of AAMI RS Guideline for Gamma Radiation Sterilization, Arlington VA, AAMI, [7] NHB A, October 1968, The Microbiological Examination of Space Hardware, National Aeronautics and Space Administration, Washington, DC [8] DAVIS, K.W., STRAWDERMAN, W.E., MASEFIELD, J. and WHITBY, J.L. DS gamma radiation dose setting and auditing strategies for sterilizing medical devices, in: Gaughran, E.R.L., and Morrissey, R.F., (eds.), Sterilization of medical products, Vol. 2. Montreal: Multiscience Publications Ltd., 1981; pp [9] DAVIS, K.W., STRAWDERMAN, W.E. and WHITBY, J.L. The rationale and computer evaluation of a gamma sterilization dose determination method for medical devices using a substerilization incremental dose sterility test protocol, J. Appl. Bact. 1984; 57; pp [10] FAVERO, M. Microbiologic Assay of Space Hardware, Environmental Biology and Medicine. 1971; 1: [11] HERRING, C. Dose audit failures and dose augmentation, Radiat. Phys. Chem. 1999; 54; pp [12] HERRING, C., BRANDSBERG, J., OXBORROW, G. and PULEO, J. Comparison of media for detection of fungi on spacecraft, Applied Microbiology, 1974; 27(3); pp [13] KOWALSKI, J., AOSHUANG, Y. and TALLENTIRE, A. Radiation sterilization Page 85 of 86