GB 16174.2-2024 English PDFUS$1039.00 · In stock
Delivery: <= 7 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 16174.2-2024: Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers Status: Valid GB 16174.2: Historical versions
Basic dataStandard ID: GB 16174.2-2024 (GB16174.2-2024)Description (Translated English): Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers Sector / Industry: National Standard Classification of Chinese Standard: C35 Word Count Estimation: 52,552 Date of Issue: 2024-08-23 Date of Implementation: 2027-09-01 Older Standard (superseded by this standard): GB 16174.2-2015 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 16174.2-2024: Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers---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 11.040.40 CCSC35 National Standard of the People's Republic of China Replaces GB 16174.2-2015 Surgical Implants Active Implantable Medical Devices Part 2.Pacemakers Part 2.Cardiac Pacemakers Released on 2024-08-23 2027-09-01 Implementation State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Symbols and abbreviations 5 5 General requirements for active implantable medical devices 5 6 Measurement of implantable pulse generator and electrode lead characteristics 6 7 General requirements for packaging 16 8 Common marking of active implantable medical devices16 9 Marking on sales packaging 16 10 Structure of sales packaging 17 11 Marking on sterile packaging 17 12 Construction of non-reusable packaging 18 13 Marking on active implantable medical devices18 14 Protection against unintended biological effects caused by active implantable medical devices19 15 Protection against harm to the patient or user caused by the external physical properties of active implantable medical devices19 16 Protection of patients from injury caused by electric current 19 17 Protection of patients from thermal injury 21 18 Protection against ionizing radiation emitted or emitted by active implantable medical devices21 19 Protection against unintended effects caused by active implantable medical devices21 20 Protection of external defibrillators from damage by active implantable medical devices23 21 Protection of active implantable medical devices against changes caused by electric fields acting directly on the patient 23 22 Protection of active implantable medical devices against changes caused by hybrid medicine 23 23 Protection of active implantable medical devices against mechanical forces23 24 Protection of active implantable medical devices from damage caused by electrostatic discharge 26 25 Protection of active implantable medical devices against damage caused by changes in atmospheric pressure 26 26 Protection of active implantable medical devices against damage caused by temperature changes26 27 Protection of active implantable medical devices from non-ionizing electromagnetic radiation 26 28 Attached Documents 26 Appendix A (Informative) Basic Principles 30 Appendix B (Informative) Code describing the working mode of implantable pulse generator 36 Appendix C (Normative) Pulse Waveform 39 Reference 41ForewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is Part 2 of GB 16174 "Surgical Implants - Active Implantable Medical Devices". GB 16174 has been published as follows part. --- Part 1.General requirements for safety, marking and information to be provided by the manufacturer; --- Part 2.Cardiac pacemakers. This document replaces GB 16174.2-2015 "Surgical implants - Active implantable medical devices - Part 2.Cardiac pacemakers" and Compared with GB 16174.2-2015, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Changed the measurement of pulse amplitude, pulse width, pulse interval and pulse frequency (see 6.1.2, 6.1.1 of the.2015 edition); --- Deleted the input impedance [see 6.1.4, 28.8.2d of the.2015 edition)]; --- Deleted the electrode lead conductor resistance (Rc) and sensor impedance (ZS) [see 6.2 and 28.8.3d of the.2015 edition)]; --- Changed the requirements for electrical neutrality (see 16.2, 16.2 of the.2015 edition); --- Changed the protection of patients from thermal injury (see 17.1, Chapter 17 of the.2015 edition); --- Changed the protection against unintended effects caused by active implantable medical devices (see 19.2, 19.2 of the.2015 edition); --- Changed the protection of active implantable medical devices against damage caused by changes in atmospheric pressure (see Chapter 25, Chapter 25 of the.2015 edition); --- Changed the protection of active implantable medical devices against non-ionizing electromagnetic radiation (see Chapter 27, Chapter 27 of the.2015 edition); --- Added that the accompanying documents should include the URL (see 28.1); --- Deleted the additional clauses in 28.22 (see 28.22 of the.2015 edition). This document is modified to adopt ISO 14708-2.2019 "Surgical implants - Active implantable medical devices - Part 2.Cardiac pacemakers". The technical differences between this document and ISO 14708-2.2019 and their reasons are as follows. --- Replace ISO 14708-1.2014 with the normative reference GB 16174.1-2024 (see Chapter 5, Chapter 7 to Chapter 19, Chapter Chapter 21 to Chapter 26, Chapter 28) to adapt to my country's technical conditions; --- Replace ISO 14117.2019 with the normative reference YY/T 1874-2023 (see Chapter 20, Chapter 21, Chapter 27) Adapt to my country's technical conditions; --- Replace ISO 11318.2002 with the normative reference YY/T 0946-2014 (see 9.4.1, 11.10, 11.11, 16.2, 23.5) to adapt to my country's technical conditions; --- Replace ISO 27186.2010 with the normative reference ISO 27186.2020 (see 6.2.2, 9.4.1, 11.10, 11.11, 16.2, 23.5), citing the relevant requirements of the latest international standards. The following editorial changes were made to this document. --- Changed the titles of Chapter 5, Chapter 21, and Chapter 28; --- Deleted Appendix A of ISO 14708-2.2019, which is a comparison table between this document and ISO /T R14283. The order of appendix numbers is adjusted accordingly. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed and coordinated by the State Food and Drug Administration. The previous versions of this document and the documents it replaces are as follows. ---First published in.2015 as GB 16174.2-2015; ---This is the first revision.IntroductionGB 16174 Surgical Implants - Active Implantable Medical Devices specifies the general requirements for active implantable medical devices, providing guidance for patients and Provide basic security for users. It is planned to include 7 parts. --- Part 1.General requirements for safety, marking and information to be provided by the manufacturer. The purpose is to specify the requirements for active implantable medical devices. General requirements for safety, marking and information to be provided by the manufacturer. --- Part 2.Cardiac pacemakers. The purpose is to specify the specific requirements for cardiac pacemakers. --- Part 3.Implantable neurostimulators (YY0989.3). The purpose is to specify the specific requirements for implantable neurostimulators. --- Part 4.Implantable infusion pumps. The purpose is to specify the specific requirements for implantable infusion pumps. --- Part 5.Circulatory support devices (YY/T 0989.5). The purpose is to specify the special requirements for circulatory support devices. --- Part 6.Particular requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias (YY0989.6). The purpose is to define active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias. Particular requirements for devices). --- Part 7.Particular requirements for cochlear implant systems (YY0989.7). The purpose is to specify the requirements for cochlear implant systems. Special requirements. This document is a revision and supplement to the general standard GB 16174.1-2024.The requirements of this document take precedence over the relevant requirements in Part 1. Require. Appendix A provides further explanation of the rationale for each clause of this document. Appendix B describes a coding system that can be used to specify bradycardia pacing modes. Appendix C specifies the reference points for measuring pulse amplitude and pulse width, and the waveform of the test signal used to determine sensitivity. Any trade names used in this document are provided for the convenience of the user and do not constitute an endorsement. Surgical Implants Active Implantable Medical Devices Part 2.Pacemakers1 ScopeThis document specifies requirements specific to cardiac pacemakers. This document applies to active implantable medical devices for the treatment of bradyarrhythmias and devices that provide cardiac resynchronization therapy, as well as Certain non-implantable parts and accessories of implantable medical devices. The tests specified in this document are type tests and compliance is confirmed by testing of samples. The electrical characteristics of the implantable pulse generator or electrode lead are verified by appropriate methods listed in this document or other methods. If other methods can be demonstrated to be equal to or superior in accuracy to the method specified, in case of dispute, the method specified in this document shall prevail. ISO 14708-6 covers all aspects of active implantable medical devices intended for the treatment of tachyarrhythmias. NOTE. What is often referred to as an “active implantable medical device” may in fact be a single device, a combination of multiple devices, or one or more devices in combination with one or more A combination of multiple accessories. Not all of these components are partially or fully implantable, but if non-implanted components or accessories may affect the implanted device To ensure the safety and performance of a device, requirements for non-implanted parts and accessories should be specified.2 Normative referencesThe contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB 16174.1-2024 Surgical implants Active implantable medical devices Part 1.Safety, marking and information provided by the manufacturer General requirements for information (ISO 14708-1.2014, MOD) YY/T 0946-2014 Cardiac Defibrillator DF-1 connector assembly dimensions and test requirements for implantable cardioverter defibrillators Request (ISO 11318.2002, MOD) Note. There is no technical difference between the referenced content of YY/T 0946-2014 and the referenced content of ISO 11318.2002. YY/T 1874-2023 Electromagnetic compatibility of active implantable medical devices - implantable cardiac pacemakers, implantable cardioverter-defibrillators Electromagnetic compatibility test details for cardiac resynchronization devices and cardiac resynchronization devices (ISO 14117.2019, IDT) ISO 5841-3.2013 Surgical implants - Cardiac pacemakers - Part 3.Small cross-section connectors for implantable cardiac pacemakers pacemakers] ISO 27186.2020 Active implantable medical devices - Implantable cardiac rhythm management devices - Four-pole connector system - Dimensions and tests3 Terms and definitionsThe terms and definitions defined in GB 16174.1-2024 and the following apply to this document. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 16174.2-2024_English be delivered?Answer: Upon your order, we will start to translate GB 16174.2-2024_English as soon as possible, and keep you informed of the progress. 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