YY/T 1712-2021 Active Industry standards-Medicine

YY/T 1712-2021 Assisted surgical medical equipment and assisted surgical medical system employing robotictechnology

Publish Date: 2021-03-09 Implement Date: 2022-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1712-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical electronic instruments and equipment

ICS Name: Medical equipment

Publish Date: 2021-03-09

Implement Date: 2022-10-01

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医用电子仪器标准化分技术委员会(SAC/TC 10/SC 5)

Pages: 22 pages

Scope

本标准规定了采用机器人技术的辅助手术设备和辅助手术系统的术语和定义、要求和试验方法。
本标准适用于采用机器人技术的辅助手术设备和辅助手术系统（以下简称“RA设备”）。

Development Information

Drafting Units:

上海市医疗器械检测所、重庆金山科技(集团)有限公司、北京天智航医疗科技股份有限公司、微创(上海)医疗机器人有限公司、上海交通大学医学院附属第九人民医院、上海联影医疗科技有限公司、天津大学、广东加华美认证有限公司上海分公司、中国人民解放军总医院、上海交通大学

Drafting Persons:

何骏、何超、洪伟、王了、赵永强、柴岗、王芸、邢元、况朝、何昆仑、徐凯、张筱莉、张维军、戴婷萍、唐佩福

Word Count: 40 Thousand words Pages: 22 pages

Referenced Standards

GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 12642-2001 Industrial robots—Performance criteria and related test methods GB/T 12642-2013 Industrial robots—Performance criteria and related test methods GB/T 12643-1997 Industrial robots—Vocabulary GB/T 12643-2013 Robots and robotic devices—Vocabulary GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment YY 0043-2005 Medical suture needle YY/T 0043-2016 Medical suture needle YY 0167-2005 Non-absorbable surglcal suture YY 0167-2020 Non-absorbable surgical suture YY/T 1686-2020 Medical electrical equipment employing robotic technology—Classification YY 0167-1998 Non-absorbable Surgical Suture YY/T 1686-2024 Medical electrical equipment employing robotic technology—Terminology,definitions and classification GB/T 12643-2025 Robotics—Vocabulary

Related Standards

GB 9706.8-1995 Replaced

GB 9706.8-1995 Medical electrical equipment—Part 2:Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

Publish Date: 1995-06-02

GB 11235-1997 Replaced

GB 11235-1997 VCu intra-uterine device

Publish Date: 1997-07-24

GB/T 17257.1-1998 Replaced

GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary

Publish Date: 1998-03-18

GB/T 17257.2-1998 Replaced

GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions

Publish Date: 1998-03-18

GB/T 17257.3-1998 Replaced

GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume

Publish Date: 1998-03-18

GB/T 17257.4-1998 Replaced

GB/T 17257.4-1998 Urine collection bags—Part 4:Determination of freedom form leakage

Publish Date: 1998-03-18