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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 42984.1-2023: Health software - Part 1: General requirements for product safety Status: Valid
Basic dataStandard ID: GB/T 42984.1-2023 (GB/T42984.1-2023)Description (Translated English): Health software - Part 1: General requirements for product safety Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C30 Classification of International Standard: 35.240.80 Word Count Estimation: 22,260 Date of Issue: 2023-09-07 Date of Implementation: 2024-10-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 42984.1-2023: Health software - Part 1: General requirements for product safety---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.ICS 35.240.80 CCSC30 National Standards of People's Republic of China health software Part 1.General requirements for product safety (IEC 82304-1.2016,MOD) Published on 2023-09-07 2024-10-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration Committee Table of contentsPreface III Introduction IV 1 Scope 1 1.1 Purpose 1 1.2 Application areas 1 1.3 Compliance 1 2 Normative reference documents 1 3 Terms and Definitions 1 4*Health Software Product Requirements4 4.1 General requirements and initial risk assessment4 4.2 Requirements for using health software products5 4.3 Verification of health software product usage requirements 5 4.4 Update usage requirements for health software products 5 4.5 System requirements 5 4.6 Verification of system requirements 6 4.7 Update system requirements for health software products 6 5 *Healthy software---Software life cycle process 6 6*Health Software Product Confirmation 6 6.1 Confirm plan 6 6.2 Implementation Confirmation 7 6.3 Confirmation report 7 7 Health Software Product Identification and Accompanying Documentation 7 7.1 *Identification 7 7.2 Accompanying documents 7 8 Post-launch activities for health software products10 8.1 General 10 8.2 Software maintenance 10 8.3 Reconfirm10 8.4 Post-launch communication for health software products10 8.5 Deactivation and disposal of health software products 11 Appendix A (Informative) Reasons for the requirements of this document 12 Reference 16 GB/T 43984.1-2023ForewordThis document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document is Part 1 of GB/T 42984 "Health Software". GB/T 42984 has released the following parts. ---Part 1.General requirements for product safety. This document is modified to adopt IEC 82304-1.2016 "Health Software Part 1.General Requirements for Product Safety". The technical differences between this document and IEC 82304-1.2016 and their reasons are as follows. ---Replaced IEC 62304.2006 and IEC 62304.2006/AMD1 with normatively cited YY/T 0664-2020. In.2015, the degree of consistency between the two documents was modified to adapt to my country's technical conditions. The following editorial changes have been made to this document. ---Replaced the IEC 60601/IEC 80601 series with the informative GB 9706 series; ---Replaced the IEC 61010 series with the informative GB 4793 (all parts); ---Replaced the ISO 14708 series with the informative GB 16174 (all parts); ---Replaced IEC 60601-1.2005/AMD1.2012 with GB 9706.1-2020; ---Replaced the source of the term "risk" in IEC 82304-1.2016 with IEC Guide63; ---Replaced the source of the term "cybersecurity" in IEC 82304-1.2016 with ISO /IEC /IEEE12207.2017 and added note; ---Deleted Note 4 of 4.2; --- Delete the last paragraph of A.1 in Appendix A about the description of different regulations applicable in international regulatory regions. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10). This document was drafted by. Beijing Yihe Jiaye Medical Technology Co., Ltd., Shanghai Institute of Medical Device Inspection, National Drug Administration Medical Device Technology Evaluation Center of the Supervision and Administration Bureau, China Institute of Food and Drug Control, and Neusoft Medical Systems Co., Ltd. The main drafters of this document. Chen Xingwen, Liu Chongsheng, Peng Liang, Li Shu, Xie Xinying, Wang Qingsong, and Chen Bei. GB/T 43984.1-2023IntroductionHealth software refers to software that contributes to an individual's health using the observation and/or demonstration of measurable health parameters or clinical expertise. This product is designed to run on a general-purpose computing platform and is intended to be marketed without specialized hardware for use by its manufacturer in managing Manage, maintain or improve personal health or provide care. Some health software may cause dangerous situations, therefore, all health software is required to be inspected Perform risk management. For health software that may lead to dangerous situations, risk controls are required to prevent harm or reduce the likelihood of harm occurring. capability. The line between health software and medical devices is difficult to distinguish. The developers of these software are usually not traditional medical device manufacturers. The development process and safety requirements of these products should be limited "in advance" by appropriate standards. Among various types of health software, health and wellness apps are a rapidly growing market, with hundreds of thousands of apps currently available. programs, the most popular of which have millions of downloads each. Some of these applications are subject to medical device regulations, but most Most are not bound by this. These apps are typically promoted directly to consumers through app stores without any formal evaluation. These applications Often collecting sensitive personal information without appropriate privacy controls, providing advice on topics such as fertility, diet or activity, or There is no evidence to support it. There are widespread concerns about the risks. At the same time, health apps have proven effective in improving quality of life quantity, and even extend lifespan, but it may not be adopted on a large scale. Many health organizations have assessment, accreditation and procurement requirements that meet local regulations application project. These campaigns are ideal for any app looking to promote or sell their products to health and wellness service providers. Manufacturers are important as providers want to ensure that the apps they recommend to patients are safe, reliable and effective. However, for For application manufacturers wishing to offer products in multiple markets, standards and assessments differ for each country, organization or region. The cost of the system is high. In order to effectively evaluate the quality and reliability of health software, including health applications, the ISO 82304 series of standards and technologies have been developed successively specifications, building on and integrating the guidelines and requirements for health software from many local and national health organizations around the world. to ensure the software is safe, reliable and effective. Currently, GB/T 42984 "Health Software" is divided into 2 parts. ---Part 1.General requirements for product safety. The purpose is to put forward requirements for the safety and network security of health software products and provide Provides guidance on future regulation and identification of liabilities for health software products. ---Part 2.Health and Wellness Application Quality and Reliability. The purpose is to define the quality and usability of health applications. Reliability-related questions and their supporting evidence to confirm (or determine) the quality and reliability of health applications. The clauses marked with an asterisk (*) in this document have explanations and explanations related to the clause in Appendix A. GB/T 43984.1-2023 health software Part 1.General requirements for product safety1 Scope1.1 Purpose This document specifies general requirements for health software product security. This document applies to the security and cybersecurity of health software products, focusing primarily on requirements for manufacturers. Health software product design It operates on a general computing platform and is expected to be available on the market without the need for specific hardware. 1.2 Application areas This document covers the entire life cycle, including design, development, installation, validation, maintenance and processing of health software products. In each referenced standard, the term "medical device" or "medical device software" is replaced, where appropriate, by the term "health software" or "health software product". "product" instead. If the term "patient" is used, whether in this document or in the referenced standard, it refers to a person whose health benefits from the use of health software personnel. This document does not apply to health software intended to be part of specific hardware designed for health use. Specifically, this document does not Applies to. a) Medical electrical equipment or systems covered by GB 9706 series; b) In vitro diagnostic equipment covered by GB 4793 (all parts); c) Implantable devices covered by GB 16174 (all parts). NOTE. This document also applies to health software products (e.g. medical applications, health applications) intended for use with mobile computing platforms. 1.3 Compliance Compliance with this document is determined by examining all documentation required by this document. Conformity is assessed and documented by the manufacturer. Health software products may require external evaluation if they need to comply with regulatory requirements. If this document normatively references sections or clauses of other standards with a safety or cybersecurity focus, the manufacturer may use the substitute The alternative method demonstrates compliance with the requirements of this document. If the process results (including traceability) of these alternative methods are clearly equivalent and the residual risk are still acceptable, these alternatives can be used.2 Normative reference documentsThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. YY/T 0664-2020 Medical device software software life cycle process (IEC 62304.2015, MOD)3 Terms and definitionsThe following terms and definitions apply to this document. 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