T/BTIAIRI 0002-2025 Active Group standards

T/BTIAIRI 0002-2025 The maturity evaluation of medical robotics technology

Publish Date: 2025-09-25 Implement Date: 2025-12-25 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/BTIAIRI 0002-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Integrated medical equipment

Publish Date: 2025-09-25

Implement Date: 2025-12-25

Scope

In addition to the standard normative elements (scope, normative reference documents, terms and definitions, etc.), the main content of the standard includes the grading and definition of the maturity level of medical robotics technology, determination rules, and evaluation processes. Among them: (1) The standard adopts a nine-level technical maturity evaluation system, clearly defining the full-cycle development path of medical robots from technology concept verification to mature product deployment, and systematically standardizing the technical characteristics and evaluation requirements at each stage. (2) The standard sets detailed technical requirements and evaluation indicators for each grade of medical robotics technology maturity, providing clear evaluation standards for determining the maturity level of the technology. (3) The evaluation process of medical robotics technology maturity includes three key steps: first, formulating a systematic evaluation plan based on the standard requirements; second, determining the maturity level based on technical characteristics and evaluation indicators; and finally, preparing a standardized evaluation report document.

Development Information

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