YY/T 0606.8-2008
Tissue engineered medical products.Part 8:Alginate (English Version)

Standard No.

YY/T 0606.8-2008

Language

Chinese, Available in English version

Release Date

2008

Published By

Professional Standard - Medicine

Status

Be replaced 2020-06

Replace By

YY/T 1654-2019

Latest

YY/T 1654-2019

Scope

This part of YY/T 0606 is applicable to the preparation of sodium alginate for tissue engineering medical products and surgical implants.

YY/T 0606.8-2008 Referenced Document

• ASTM F2064-00 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application*， 2024-04-18 Update
• ASTM F2259-03 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (¹H NMR) Spectroscopy*， 2024-04-18 Update
• GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
• GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
• GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
• GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
• GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
• GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
• GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation
• GB/T 191 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
• YY/T 0313-1998 Package,lable,transport and storage for medical polymer products

YY/T 0606.8-2008 history

• 2019 YY/T 1654-2019 Tissue engineering medical device product sodium alginate
• 2008 YY/T 0606.8-2008 Tissue engineered medical products.Part 8:Alginate

YY/T 0606.8-2008 Tissue engineered medical products.Part 8:Alginate was changed to YY/T 1654-2019 Tissue engineering medical device product sodium alginate.