YY/T 0513.1-2019 Active Industry standards-Medicine

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

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

Publisher: 国家药品监督管理局

Technical Committee: 中国食品药品检定研究院

Pages: 12 pages

Scope

YY/T 0513的本部分规定了组织库质量管理的基本要求，对同种异体组织库从知情同意或授权、捐献者适用性评估，以及组织产品的采集、加工、包装、标识和分发等全过程活动进行规定。
本部分适用于同种异体组织库运行及其产品质量控制。

Development Information

Drafting Units:

中国人民解放军总医院、山西省医用组织库、中国食品药品检定研究院

Drafting Persons:

卢世璧、郭全义、赵亚平、徐丽明、彭江、许文静、邵安良、赵师充、鲜海、冯晓明、奚廷斐

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

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