GB/T 36988-2018 Active National standards

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

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

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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

Pages: 24 pages

Scope

This standard specifies the requirements for human cells, tissues, and cell/tissue-based products (HCT/Ps) at all stages of production, including establishing a quality system, facilities, cell and tissue collection, processing, product storage and transportation, recall, and donor qualification assessment. This standard applies to the production of human cells, tissues, or cell/tissue-based products for tissue engineering. This standard does not apply to organ transplantation and reproductive cell operations.

Development Information

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

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