T/ZGCIT 015-2024 Active Group standards

T/ZGCIT 015-2024 Human umbilical cord mesenchymal stem cell clinical application guidelines for knee osteoarthritis

Publish Date: 2024-12-30 Implement Date: 2024-12-30 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/ZGCIT 015-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated medical equipment

Publish Date: 2024-12-30

Implement Date: 2024-12-30

Scope

Scope: This document specifies the requirements for institutions and personnel involved in the treatment of knee osteoarthritis with human umbilical cord mesenchymal stem cells, the process of obtaining human umbilical cord mesenchymal stem cells and local injection treatment, as well as the post-treatment examination, follow-up tracking, and monitoring procedures for patients. This document is applicable to orthopedics and arthroscopic surgery departments in general hospitals for the treatment of knee osteoarthritis caused by degenerative lesions using human umbilical cord mesenchymal stem cells. Main technical content: This document specifies the requirements for institutions and personnel involved in the treatment of knee osteoarthritis with human umbilical cord mesenchymal stem cells, the process of obtaining human umbilical cord mesenchymal stem cells and local injection treatment, as well as the post-treatment examination, follow-up tracking, and monitoring procedures for patients.

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