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GB/T 19973.1-2023: Sterilization of health care products--Microbiological methods - Part 1: Determination of a population of microorganisms on products Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB/T 19973.1: Historical versions
Similar standardsGB/T 19973.1-2023: Sterilization of health care products--Microbiological methods - Part 1: Determination of a population of microorganisms on products---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT19973.1-2023 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.080.01 CCS C 47 GB/T 19973.1-2023 / ISO 11737-1.2018 Replacing GB/T 19973.1-2015 Sterilization of Health Care Products - Microbiological Methods – Part 1.Determination of a Population of Microorganisms on Products (ISO 11737-1.2018, IDT) 确实 Issued on: MARCH 17, 2023 Implemented on: OCTOBER 1, 2024 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 Introduction... 5 1 Scope... 7 2 Normative References... 7 3 Terms and Definitions... 8 4 General Requirements... 11 5 Selection of Products... 12 6 Methods of Determination and Microbial Characterization of Bioburden... 13 7 Validation of the Method for Determining Bioburden... 15 8 Routine Determination of Bioburden and Interpretation of Data... 16 9 Maintenance of the Method for Determining Bioburden... 17 Annex A (Informative) Guidance on the Determination of a Population of Microorganisms on Products... 18 Annex B (Informative) Guidance on Methods to Determine Bioburden... 40 Annex C (Informative) Validation of Bioburden Recovery Efficiency... 52 Annex D (Informative) Typical Assignment of Responsibilities... 61 Bibliography... 63ForewordThis Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for Standardization – Part 1.Rules for the Structure and Drafting of Standardizing Documents. This Document is Part 1 of GB/T 19973 Sterilization of Health Care Products - Microbiological Methods. GB/T 19973 consists of the following parts. --- Part 1.Determination of a Population of Microorganisms on Products; --- Part 2.Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process. This Document replaced GB/T 19973.1-2015 Sterilization of Medical Devices – Microbiological Methods – Part 1.Determination of a Population of Microorganisms on Products. Compared with GB/T 19973.1-2015, the major technical changes of this Document are as follows besides the structural adjustments and editorial modifications. --- Added the term "bioburden spike" and its definition (see 3.6 of this Edition); --- Add attention to the impact of changes in products and/or production processes on bioburden determination methods (see 9.1 of this Edition). This Document equivalently adopted ISO 11737-1.2018 Sterilization of Health Care Products – Microbiological Methods – Part 1.Determination of a Population of Microorganisms on Products. This Document made the following minimum editorial modifications. --- Incorporate the amendments to ISO 11737-1.2018/Amd.1.2021.The affected clauses are marked with a double vertical line (‖) in the outer margins. --- Add the Pharmacopoeia of the People's Republic of China to the pharmacopoeia examples (see A.4.3 of this Document). Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents. This Document was proposed by National Medical Products Administration. This Document shall be under the jurisdiction of National Technical Committee on Sterilization Techniques and Equipment of Standardization Administration of China (SAC/TC 200). Drafting organizations of this Document. Suzhou ProSteri Medical Technology Co., Ltd.; Hangzhou Endonom Medtech Co., Ltd.; Guangdong Medical Devices Quality Surveillance and Test Institute; Johnson & Johnson Medical (Suzhou) Ltd.; Terumo Medical Products Sterilization of Health Care Products - Microbiological Methods – Part 1.Determination of a Population of Microorganisms on Products1 ScopeThis Document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1.The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2.See Annex A for guidance on Clauses 1 to 9. This document does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3.Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and ISO 13022. This Document does not apply to the microbiological monitoring of the environment in which health care products are manufactured.2 Normative ReferencesThe provisions in following documents become the essential provisions of this Document through reference in this Document. For the dated documents, only the versions with the dates indicated are applicable to this Document; for the undated documents, only the latest version (including all the amendments) is applicable to this Document. ISO 13485 Medical devices – Quality management systems – requirements for regulatory purposes NOTE. YY/T 0287-2017 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485.2016, IDT) ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
