YY/T 0513.1-2019 Active Industry standards-Medicine

YY/T 0513.1-2019 Allogeneic grafts—Part 1:The basic requirements for tissue bank

YY/T 0513.1-2019 Allogeneic grafts—Part 1:The basic requirements for tissue bank

Publish Date: 2019-10-23 Implement Date: 2020-10-01 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: YY/T 0513.1-2019

Standard Type: Industry 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: 2019-10-23

Implement Date: 2020-10-01

Pages: 12 pages

Scope

This part of YY/T 0513 specifies the basic requirements for the quality management of tissue banks, and stipulates the entire process of allogeneic tissue banks, including informed consent or authorization, donor suitability assessment, and the collection, processing, packaging, labeling, and distribution of tissue products.
This part is applicable to the operation of allogeneic tissue banks and the quality control of their products.

Development Information

Word Count: 22 Thousand words Pages: 12 pages

Replace the following standards

YY/T 0513.1-2009

Referenced Standards

中华人民共和国药典(2015版) GB/T 16292-1996 Test method for airborne particles in clean room (area) the pharmaceutical industry GB/T 16292-2010 Test method for airborne particles in clean room (zone) of the pharmaceutical industry GB/T 16293-1996 Test method for airborne microbe in clean room(area) the pharmaceutical industry GB/T 16293-2010 Test method for airborne microbe in clean room(zone) of the pharmaceutical industry GB/T 16294-1996 Test method for settling microbe in clean room(area) the pharmaceutical industry GB/T 16294-2010 Test method for settling microbe in clean room(zone) of the pharmaceutical industry GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems YY/T 0033-2000 Good manufacture practice for sterile medical devices YY 0236-1996 Drug packaging composite film (General) YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0033-1990 Sterile medical device production management specifications YY 0033-2000 Sterile medical device production management regulations GB/T 16292-2025 Test method for airborne particles in clean room(zone) of the pharmaceutical industry GB/T 16293-2025 Test method for airborne microbe in clean room(zone) of the pharmaceutical industy GB/T 16294-2025 Test method for settling microbe in clean room (zone)of the pharmaceutical industy

Related Standards

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GB 12279-1990 Replaced

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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