YY/T 9706.110-2021 Active Industry standards-Medicine

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

Publish Date: 2021-03-09 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 9706.110-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2021-03-09

Implement Date: 2023-05-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用电器标准化技术委员会(SAC/TC 10)

Pages: 28 pages

Scope

YY/T 9706的本部分规定了在医用电气设备和医用电气系统(以下简称ME设备和ME系统)中，用于控制生理变量的生理闭环控制器(PCLC)作为生理闭环控制系统(PCLCS)一部分时的开发 (分析、设计、验证和确认)要求。
注：生理变量可以是人体化学成分（如电解质、血糖）、物理特性（如患者体温、电生理现象、血液动力学）或药物浓度。
本部分适用于ME设备和ME系统的基本安全和基本性能。
本部分适用于各种类型的PCLC，如线性和非线性、自适应、模糊、神经网络等。
本部分的内容不包括：
——附加的机械要求；或
——附加的电气要求。
本部分适用于闭环控制器（见图1），通过设定控制器输出变量并与参考变量相关联，以调节（即改变或维持）测定的生理变量。
本部分不适用于采用非患者测量所得的反馈数据来维持物理或化学变量的闭环控制器。
注：本部分中带星号(*)的章和条在附录A中有相关原理说明。

Development Information

Drafting Units:

上海市医疗器械检测所、通标标准技术服务(上海)有限公司

Drafting Persons:

何骏、尹勇

Word Count: 50 Thousand words Pages: 28 pages

Same series standard

Referenced Standards

GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 1474-2016 Medical devices—Application of usability engineering to medical devices YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis

Adopt standards

IEC 60601-1-10:2007+A1:2013

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24