YY/T 1654-2019 Active Industry standards-Medicine

YY/T 1654-2019 Tissue engineering medical device products—Alginate

YY/T 1654-2019 Tissue engineering medical device products—Alginate

Publish Date: 2019-05-31 Implement Date: 2020-06-01 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 1654-2019

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: 2019-05-31

Implement Date: 2020-06-01

Pages: 15 pages

Scope

This standard specifies the requirements for sodium alginate as a raw material, test methods, inspection rules, marking, packaging, etc.
This standard applies to sodium alginate used in the preparation of tissue engineering medical device products and their scaffold materials.

Development Information

Word Count: 26 Thousand words Pages: 15 pages

Replace the following standards

YY/T 0606.8-2008 Tissue engineered medical products—Part 8:Alginate

Referenced Standards

中华人民共和国药典(2015年版) GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process YY/T 0313-1998 Package,lable,transport and storage for medical polymer products YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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