GB/T 36988-2018 Active National standards

GB/T 36988-2018 Guidance for good tissue practice of human origin for tissue engineered medical products

Publish Date: 2018-12-28 Implement Date: 2021-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 36988-2018

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2018-12-28

Implement Date: 2021-01-01

Publisher: 国家市场监督管理总局、中国国家标准化管理委员会

Technical Committee: 全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)

Pages: 24 pages

Scope

本标准规定了人源细胞、组织和以细胞、组织为基础的产品(HCT/Ps)在生产各个环节的要求，包括建立质量体系、设施、细胞及组织采集、加工、产品保存及运输、召回以及供体资质评估等。本标准适用于组织工程用人源细胞、组织或以细胞、组织为基础的产品的生产操作。本标准不适用于器官移植及生殖细胞的操作。

Development Information

Drafting Units:

中国食品药品检定研究院

Drafting Persons:

孟淑芳、徐丽明、吴瑜、林林、吴雪伶、邵安良、樊金萍

Word Count: 44 Thousand words Pages: 24 pages

Referenced Standards

GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices YY/T 0606.16 YY/T 1445-2016 Tissue engineering medical device products—Terminology ISO 13408-1:2008 ISO 13408-7:2012 ISO 14160:2011 ISO 14937:2000 ISO 17665-1:2006 ISO 18362:2016 ISO 20857:2010 ISO 25424:2009 YY/T 0033-2000 Good manufacture practice for sterile medical devices YY/T 0033-1990 Sterile medical device production management specifications YY 0033-2000 Sterile medical device production management regulations

Related Standards

GB 12264-1990 Replaced

GB 12264-1990 Artificial heart-lung machine Silicon rubber pump tube

Publish Date: 1990-01-08

GB 12279-1990 Replaced

GB 12279-1990 Cardiac valve prostheses general technical specification

Publish Date: 1990-03-26

GB 12417-1990 Replaced

GB 12417-1990 The general technological conditions of surgical metal implant

Publish Date: 1990-07-17

GB/T 13461-1992 Replaced

GB/T 13461-1992 Synthetic resin blow knee prostheses

Publish Date: 1992-06-01

GB/T 14191-1993 Replaced

GB/T 14191-1993 Terminology for prosthetics and orthotics

Publish Date: 1993-02-25

GB 14722-1993 Replaced

GB 14722-1993 Endoskeletal above knee prosthesis

Publish Date: 1993-12-04