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YY 0989.3-2023: Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
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Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
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Basic data | Standard ID | YY 0989.3-2023 (YY0989.3-2023) | | Description (Translated English) | Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 46,434 | | Date of Issue | 2023-06-20 | | Date of Implementation | 2026-07-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies specific requirements for implantable neurostimulators. This standard applies to active implantable medical devices that provide electrical stimulation to the central nervous system or peripheral nervous system. | YY 0989.3-2023: Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
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ICS 11.040.40
CCSC35
Pharmaceutical Industry Standards of the People's Republic of China
Surgical Implants Active Implantable Medical Devices
Part 3.Implantable Neurostimulators
(ISO 14708-3.2017,MOD)
Published on 2023-06-20
2026-07-01 Implementation
Released by the State Drug Administration
Table of contents
Preface III
Introduction IV
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Symbols and abbreviations2
5 General requirements for active implantable medical devices2
6 Requirements for certain active implantable medical devices2
7 General requirements for packaging2
8 Common markings for active implantable medical devices3
9 Markings on sales packaging3
10 Structure of sales packaging 3
11 Marking on sterile packaging3
12 Construction of non-reusable packaging3
13 Markings on active implantable medical devices3
14 Protection against unintended biological effects caused by active implantable medical devices3
15 Protection against harm to patients or users caused by the external physical characteristics of active implantable medical devices5
16 Protection against harm to patients caused by electric current 5
17 Protection of patients from thermal injury5
18 Protection against ionizing radiation released or emitted by active implantable medical devices6
19 Protection against unintended effects caused by active implantable medical devices6
20 Protection of active implantable medical devices from damage caused by external defibrillators6
21 Protection of active implantable medical devices against changes caused by electric fields acting directly on patients7
22 Protection of active implantable medical devices from changes caused by hybrid medicine7
23 Protection of active implantable medical devices from mechanical forces 8
24 Protection of active implantable medical devices from damage caused by electrostatic discharge9
25 Protection of active implantable medical devices from damage caused by changes in atmospheric pressure 9
26 Protection of active implantable medical devices from damage caused by temperature changes 9
27 Protection of active implantable medical devices against non-ionizing electromagnetic radiation 9
28 Accompanying documents 18
Appendix AA (Informative) Basic Principles 20
Appendix BB (Informative) Injection Network Examples and Board Layout Guidelines 29
Reference 39
Figure 101 Injection network with frequency range 16.6Hz~80MHz Figure 12
Figure 102 Amplitude modulated test signal for voltage injection test 14
Figure 103 Amplitude modulated test signal for radiated magnetic field test 15
Figure 104 IPG and electrode lead layout 16
Figure AA.1 CEM43 and temperature 21 in constant time
Figure AA.2 Two examples of the same CEM43 results obtained with different exposure times22
Figure AA.3 Time and temperature curve example 22
Figure AA.4 Magnetic field environment test reference level 26
Figure AA.5 Injection voltage test level 27 from 16.6Hz to 80MHz
Figure BB.1 Example of organizational equivalent interface board 30
Figure BB.2 DUT contact plate example 33
Figure BB.3 Simplified electrode wire model (distribution parameters) 34
Figure BB.4 Simplified electrode lead model (lumped parameters) 34
Figure BB.5 Example of board layout plan 38
Table 101 CEM43 dose thresholds for various tissues5
Table 102 Acceptance criteria for ISO /T S10974 test requirements 7
Table 103 Minimum content of risk management and test reports10
Table 104 Frequency step 13 for voltage injection test
Table 105 Peak-peak injection test level VPP 13
Table 106 Minimum magnetic field test level H 14
Table 107 Frequency step 14 for radiated magnetic field test
Table 108 Near field test method requirements 16
Table 109 Test frequency, modulation and net RF power17
Table AA.1 Evaluation of CEM43 formula 21 at different temperatures
Table AA.2 Magnetic field test reference level 26
Table AA.3 Peak-peak injection test level VPP 27
Table BB.1 Organization interface circuit switch configuration example 31
Foreword
This 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 3 of "Surgical Implants Active Implantable Medical Devices", "Surgical Implants Active Implantable Medical Devices"
The following sections have been published.
---Part 1.General requirements for safety, marking and information provided by manufacturers;
---Part 2.Pacemaker;
---Part 3.Implantable neurostimulator;
---Part 5.Circulatory support devices;
---Part 6.Special requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias;
---Part 7.Special requirements for cochlear implant systems.
This document uses the redrafted method and is modified to adopt ISO 14708-3.2017 "Surgical Implants and Active Implantable Medical Devices - Part 3"
"Implantable neurostimulator".
Compared with ISO 14708-3.2017, the main technical changes and reasons for this document are as follows.
a) Regarding normative reference documents, this document has been adjusted with technical differences to adapt to my country’s technical conditions and the circumstances of the adjustment.
The situation is reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace IEC 60601-1.2012 with GB 9706.1, which is modified to adopt international standards;
● Replace ISO 14708-1 with GB 16174.1, which is equivalent to the international standard;
● Replace IEC 61000-4-3.2006 A1.2007 A2.2010 with GB/T 17626.3, which is equivalent to the international standard;
● Replace ISO 14971 with YY/T 0316, which is equivalent to the international standard;
● Replace IEC 60601-1-2 with YY 9706.102, which is modified to adopt international standards.;
● Added reference to GB/T 2423.43-2008 (see 23.2);
● Added reference to GB/T 2423.56-2018 (see 23.2).
b) Delete the informative appendix AA in the ISO 14708-3.2017 standard. This appendix is the comparison between this document and ISO /T R14283.
Correspondence table;
c) Added some updated content in ISO 14708-1.2014, because ISO 14708-3.2017 corresponds to ISO 14708-1.2014
The special requirements of ISO 14708-1.2014 are added to this special standard (see 13.1, 14.2, 16.2,
17.2,19.2,23.2,23.6,28.4,28.19,28.105).
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 sponsored by the National Surgical Implants and Orthopedic Instruments Standardization Technical Committee Active Implants Sub-Technical Committee (SAC/TC110/
SC4) Return to home.
Introduction
"Surgical Implants and Active Implantable Medical Devices" contains 7 parts.
---Part 1.General requirements for safety, marking and information provided by the manufacturer. The purpose is to provide for active implantable medical devices
General requirements for safety, labeling and information provided by manufacturers
---Part 2.Pacemaker. The purpose is to specify specific requirements for cardiac pacemakers
---Part 3.Implantable neurostimulator. The purpose is to specify specific requirements for implantable neurostimulators
---Part 4.Implantable infusion pump. The purpose is to specify specific requirements for implantable infusion pumps
---Part 5.Circulatory support devices. The purpose is to specify specific requirements for circulatory support devices
---Part 6.Special requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias.
The purpose is to specify specific requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias
---Part 7.Special requirements for cochlear implant systems. The purpose is to specify specific requirements for cochlear implant systems.
This document specifies specific requirements for active implantable medical devices that perform electrical stimulation of the central nervous system or peripheral nervous system.
Provide basic safety for patients and users.
This document is a special standard and is a reference to the general standard GB 16174.1 "Surgical Implants, Active Implantable Medical Devices - Part 1.Safety"
Modifications and additions to General Requirements for Safety, Marking and Information Provided by Manufacturers. The requirements of this document take precedence over those in Part 1
Require.
Devices that use electricity to stimulate the nervous system are often called neurostimulators. They generate controlled electrical pulses that pass through
Electrodes that contact a specific target area fire. Whether the neurostimulator is fully implanted or partially implanted, it usually requires leads or extensions
Leads carry stimulation pulses from the pulse generator to the electrodes, but newer devices may not require electrode leads or extension leads. a kind of body
External programmer can be used to adjust instrument parameters.
Currently, there are a variety of neurostimulators used to treat the central nervous system or peripheral nervous system. Regardless of their therapy, this document addresses these categories
All types of neurostimulators are suitable.
This document covers all components and accessories of the implantable neurostimulator, including programmer, software and technical manuals. Not neurostimulation
All parts and accessories of the device are required to be implanted in whole or in part unless they may affect the safety or performance specified by the manufacturer.
Requirements for these non-implantable parts and accessories are to be specified.
This document does not include non-implantable medical devices such as extracorporeal neurostimulators and radiofrequency coupled neurostimulators, although these devices may
Contains implanted parts. Because these devices are already covered by the IEC 60601-1 series of standards.
Changes to the provisions in Part 1 of this document are designated by the following words.
"Replacement". The content of a chapter or article in Part 1 is completely replaced by the content of this document.
"Addition". Add the contents of this document to the requirements of Part 1.
"Modification". The content of the chapter or article in Part 1 is modified based on the content of this document.
"Unused". The content of a chapter or clause in Part 1 is not used in this document.
Articles, figures or tables continue from Part 1 and are numbered starting from 101; supplementary appendices are numbered AA, BB, etc.
Surgical Implants Active Implantable Medical Devices
Part 3.Implantable Neurostimulators
1 Scope
This document specifies specific requirements for implantable neurostimulators.
This document applies to active implantable medical devices that perform electrical stimulation of the central nervous system or peripheral nervous system.
Note. The tests specified in this document are type tests and are performed on samples to evaluate the behavioral response of the device. These tests are not intended to be used in the manufacture of devices.
Routine testing of finished products.
2 Normative reference documents
The 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.
GB/T 2423.43-2008 Environmental testing of electrical and electronic products Part 2.Test methods vibration, impact and similar dynamics
Installation of test samples (IEC 60068-2-47.2005, IDT)
GB/T 2423.56-2018 Environmental testing Part 2.Test method Test Fh, broadband random vibration and guidelines
(IEC 60068-2-64.2008,IDT)
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (GB 9706.1-2020,
IEC 60601-1.2012, MOD)
GB 16174.1 Surgical implants Active implantable medical devices Part 1.Safety, marking and communication of information provided by the manufacturer
Application requirements (GB 16174.1-2015, ISO 14708-1.2000, IDT)
GB/T 17626.3 Electromagnetic compatibility testing and measurement technology Radio frequency electromagnetic field radiation immunity test (GB/T 17626.3-
2016,IEC 61000-4-3.2010,IDT)
YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007 correction
version, IDT)
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and basic performance Parallel standards. Electromagnetic and
Capacity requirements and tests (YY 9706.102-2021, IEC 60601-1-2.2007, MOD)
ISO 14117.2012 Electromagnetic compatibility of active implantable medical devices, implantable pacemakers, implantable cardioverter defibrillators
ISO /T S10974 Assessment of the safety of magnetic resonance imaging in patients wearing active implantable medical devices (Assessmentofthe
3 Terms and definitions
The terms and definitions defined in GB 16174.1 (hereinafter referred to as Part 1) and the following terms and definitions apply to this document.
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