DB31/T 979-2016 (English Version) PDF

Standard No.: DB31/T 979-2016
Language: Chinese, Available in English version
Release Date: 2016
Published By: Shanghai Provincial Standard of the People's Republic of China
Latest: DB31/T 979-2016

Scope: This standard specifies the overall principles for setting up a clinical tissue engineering technology platform (hereinafter referred to as the platform), hardware setting requirements, basic production process operation requirements, quality control requirements and management requirements. This standard applies to the design, construction, inspection, maintenance, operation management and acceptance of newly built, renovated and expanded platforms.

DB31/T 979-2016 Referenced Document

DB31/T 687 Basic requirements for clinical cell therapy platform settings
GB 19489 Laboratories.General requirements for biosafety
GB 50016 Architectural design code for fire protection
GB 50052 Code for design electric power supply system
GB 50333 Architectural technical code for hospital clean operating department
GB 50346 Architectural and technical code for biosafety laboratories
GB 50457 Design standards for clean workshops in the pharmaceutical industry*， 2019-10-12 Update
GB 50591 Code for construction and acceptance of cleanroom
GB/T 16292 Test method for airborne particles in clean room(zone) of the pharmaceutical industry
GB/T 16293 Test method for airborne microbe in clean room(zone) of the pharmaceutical industry
ISO 14644 Cleanrooms and associated controlled environments — Part 9: Assessment of surface cleanliness for particle concentration*， 2022-05-09 Update

2016 DB31/T 979-2016 Essential requirements of tissue engineering technology platform for clinical therapy