Translated English of Chinese Standard: GB18281.1-2015 www.chinesestandard.net Sales@ChineseStandard.net ICS 11.080.01 C 47 NATIONAL STANDARD OF THE PEOPLE'S REPUBLIC OF CHINA GB / ISO 11138-1:2006 Replacing GB 18281.1-2000 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138:2006, IDT) Issued on: December 10, 2015 Implemented on: January 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. www.chinesestandard.net Page 1 of 54
Table of Contents Foreword... 3 Introduction... 6 1 Scope... 7 2 Normative references... 7 3 Terms and definitions... 8 4 General manufacturing requirements... 12 5 Specific manufacturing requirements... 15 6 Determination of resistance... 17 7 Culture conditions... 19 Annex A (Normative) Determination of viable count... 21 Annex B (Normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes... 23 Annex C (Normative) D value determination by survivor curve method... 26 Annex D (Normative) D value determination by fraction negative method... 31 Annex E (Normative) Survival-kill response characteristics... 48 Annex F (Informative) Relationship between components of biological indicators... 50 Bibliography... 52 www.chinesestandard.net Page 2 of 54
Foreword All technical content of this Part of GB 18281 is mandatory. GB 18281 consists of the following 5 parts, under the general title Sterilization of health care products - Biological indicators: - Part 1: General requirements; - Part 2: Biological indicators for ethylene oxide sterilization processes; - Part 3: Biological indicators for moist heat sterilization processes; - Part 4: Biological indicators for dry heat sterilization processes; - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes. This Part is Part 1 of GB 18281. This Part is drafted in accordance with the rules given in GB/T 1.1-2009. This Part replaces GB 18281.1-2000 Sterilization of health care products - Biological indicators - Part 1: General requirements. Compared with GB 18281.1-2000, main technical changes in this Part are as follows: - ADD the specific information of self-contained biological indicators; - ADD figures and tables of the general requirements for labellling; - ADD the requirements for specific minimum biomass and/or resistance standard scope in the use of biological indicators, those scope are detailed indicated in product labelling; - SPECIFY in Annex D that it can use HSKP, LHSKP and SMCP procedures to calculate D value. This Part uses translation method to identically adopt ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements. Corresponding Chinese documents of the international document in the normative reference of this Part are as follows: - GB/T 7408-2005 Data elements and interchange formats - Information interchange - Representation of dates and times (ISO 8601:2000, IDT); - Sterilization of health care products - Biological indicators - www.chinesestandard.net Page 3 of 54
Part 1: General requirements (ISO 11138-1:2006, IDT); - GB 18281.2-2015 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006, IDT); - GB 18280.1-2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, IDT); - GB 18280.2-2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, IDT); - GB/T 18280.3-2015 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006, IDT); - GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, IDT); - GB/T 19633.2-2015 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, IDT); - GB/T 19973.1-2015 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006, IDT); - GB/T 24628-2009 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006, IDT); - YY/T 0287-2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003, IDT); - YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223:2008, IDT). This Part has the following editorial modifications: - MADE some editorial modifications according to the rules given in GB/T 1.1; - DELETE the foreword of the international standard; Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing organizations of this document shall not be held responsible for identifying any or all such patent rights. www.chinesestandard.net Page 4 of 54
Sterilization of health care products - Biological indicators - Part 1: General requirements 1 Scope 1.1 General 1.1.1 This Part of GB 18281 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. 1.1.2 This Part specifies basic and common requirements that are applicable to all subsequent parts of GB 18281. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of GB 18281. If no specific subsequent part is provided, this Part applies. 1.2 Exclusions This Part does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This Part, however, could contain elements relevant to such microbiological test systems. 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. ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11135-2 Sterilization of health care products - Ethylene oxide - Part 2: www.chinesestandard.net Page 7 of 54