T/CIE 210-2024 Active Group standards

T/CIE 210-2024 General technical requirements of human body piercing equipment using robotic technology

T/CIE 210-2024 General technical requirements of human body piercing equipment using robotic technology

Publish Date: 2024-03-20 Implement Date: 2024-03-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: T/CIE 210-2024
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical devices
ICS Name: Medical equipment
Publish Date: 2024-03-20
Implement Date: 2024-03-20
Pages: 16 pages

Scope

This document specifies the classification, composition, functions, technical requirements, and test methods for human piercing devices that employ robotics technology.
This document applies to the use of human piercing devices that employ robotics technology in guidance, positioning, detection, measurement, and identification.
Note: For the sake of clarity, in this document, "human piercing devices that employ robotics technology" is referred to as "piercing robots".

Development Information

Word Count: 17 Thousand words Pages: 16 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 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/T 0664-2008 Medical device software—Software life cycle processes YY/T 0664-2020 Medical device software—Software life cycle processes YY/T 1686-2020 Medical electrical equipment employing robotic technology—Classification GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity YY/T 1837-2022 Medical electrical equipment—General requirements for reliability YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests

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