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YY/T 9706.110-2021: Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
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Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
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YY/T 9706.110-2021
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Basic data | Standard ID | YY/T 9706.110-2021 (YY/T9706.110-2021) | | Description (Translated English) | Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 26,265 | | Issuing agency(ies) | State Drug Administration | YY/T 9706.110-2021: Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
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Medical electrical equipment - Part 1-10.General requirements for basic safety and essential performance - Collateral Standard. Requirements for the development of physiologic closed-loop controllers
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standards
Medical Electrical Equipment Part 1-10.Basic Safety
Parallel standards with general requirements for basic performance.
Physiological closed-loop controller development requirements
(IEC 60601-1-10.2007 A1.2013,MOD)
Released on 2021-03-09
2023-05-01 implementation
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅰ
1 Scope, purpose and related standards 1
2 Normative references 1
3 Terms and definitions 2
4 *General requirements 5
5 ME equipment identification, marking and documentation 6
6 Accuracy of controllers and instruments and protection of dangerous outputs 6
7 *Programmable Medical Electrical System (PEMS) 7
8 Requirements for the development of Physiological Closed Loop Controller (PCLC) 7
Appendix A (informative appendix) General guidance and principle explanation 12
Appendix B (informative appendix) Description of PCLCS dynamic performance 19
Appendix C (informative appendix) Guidelines for marking and marking requirements for ME equipment and ME systems 22
References 23
Foreword
YY/T 9706 "Medical Electrical Equipment" series standards are divided into two parts.
---Part 1.General and parallel requirements;
---Part 2.Special requirements.
This part is part 1-10 of YY/T 9706.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
The revision of this part adopts IEC 60601-1-10.2007 A1.2013 "Medical Electrical Equipment Part 1-10.Basic Safety and Basic
Parallel standards for general performance requirements. Physiological closed-loop controller development requirements" (English version).
Compared with IEC 60601-1-10.2007 A1.2013, the main technical changes in this part are as follows except for editorial changes.
---Regarding normative reference documents, this section has made adjustments with technical differences, and has used my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace IEC 60601-1.2012 with GB 9706.1-2020, which is modified to adopt international standards;
● Replace IEC 60601-1-6.2013 with YY/T 9706.106 which is modified to adopt international standards;
● Replace IEC 60601-1-8.2012 with YY 9706.108-2021 which is modified to adopt international standards;
● Replace IEC 62366.2007 with YY/T 1474 which is modified to adopt international standards;
● Replace ISO 14971 with YY/T 0316 which is equivalent to adopting international standards;
---Some typesetting formats have been modified in accordance with GB/T 1.1;
---In order to facilitate the understanding of the original standard, the standard referenced in the appendix (informative appendix) retains the original standard number;
---The index is deleted.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Medical Electrical Appliance Standardization Technical Committee (SAC/TC10).
Drafting organizations of this section. Shanghai Medical Device Testing Institute, Shanghai Standard Technical Service (Shanghai) Co., Ltd.
The main drafters of this section. He Jun, Yin Yong.
Medical Electrical Equipment Part 1-10.Basic Safety
Parallel standards with general requirements for basic performance.
Physiological closed-loop controller development requirements
1 Scope, purpose and related standards
1.1 *Scope
This part of YY/T 9706 specifies that in medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME system),
The development of a physiological closed-loop controller (PCLC) used to control physiological variables as part of a physiological closed-loop control system (PCLCS) (analysis,
Design, verification and validation) requirements.
Note. Physiological variables can be human chemical components (such as electrolytes, blood sugar), physical properties (such as patient temperature, electrophysiological phenomena, hemodynamics) or drugs
concentration.
This section applies to the basic safety and basic performance of ME equipment and ME systems.
This section applies to various types of PCLC, such as linear and non-linear, adaptive, fuzzy, neural network, etc.
The content of this section does not include.
---Additional mechanical requirements; or
---Additional electrical requirements.
This part is applicable to closed-loop controllers (see Figure 1). The output variables of the controller are set and related to the reference variables to adjust (that is, change the
Change or maintain) the measured physiological variables.
This section does not apply to closed-loop controllers that use feedback data from non-patient measurements to maintain physical or chemical variables.
Note. The chapters and articles with an asterisk (*) in this section have relevant principles in Appendix A.
1.2 Purpose
Prescribe general requirements beyond the requirements of general standards and serve as the basis for specific standards.
1.3 Related standards
1.3.1 GB 9706.1
For ME equipment and ME systems, this section is a supplement to GB 9706.1.
When referring to GB 9706.1 or this part alone or in combination, the following conventions are used.
--- "General Standard" refers to a separate GB 9706.1;
--- "This Part" refers to a separate YY/T 9706.110 (IEC 60601-1-10);
--- "This standard" refers to the combination of the general standard and this part.
1.3.2 Specific standards
The requirements of the specific standards take precedence over the corresponding requirements in this section.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
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