GB 9706.8-1995
Replaced
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
Price:
$ 31.00
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
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
Related Standards
GB 11235-1997
Replaced
GB 11235-1997 VCu intra-uterine device
GB/T 17257.1-1998
Replaced
GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary
GB/T 17257.2-1998
Replaced
GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
Replaced
GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
Replaced