YY/T 9706.110-2021Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral standard: Requirements for the development of physiologic closed-loop controllers (English PDF)

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.

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.

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 document.