YY/T 1654-2019Tissue engineering medical device products—Alginate (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard is a revision of YY/T 0606.8-2008 "Organizational Engineering Medical Products Part 8. Sodium Alginate". With YY/T 0606.8- Compared with.2008, the main technical changes except editorial changes are as follows.

--- The standard name was changed to "Sodium alginate for tissue engineering medical device products";

--- Removed the GB/T 16886 series of normative references (only GB/T 16886.1 reserved) (see 2, 2008 edition 2);

--- Revised the version number of GB/T 2828.1, GB/T 16886.1, YY/T 0313 and Chinese Pharmacopoeia in the normative reference documents (see 2, 2008 edition of 2);

--- Removed the specific requirements and test methods of biological evaluation, and only retained the general rules (see 5.11, 4.11, 5.11 of the 2008 edition);

--- Revised the test method for protein content (see Appendix C, Appendix C of the 2008 edition);

--- Revised reference ASTM F2064 version number (see references, 2008 edition of reference);

--- Deleted the background information of Appendix D (informative) (Appendix D of the 2008 edition);

--- Added reference USP 35-NF30 (see references).

1 Scope

This standard specifies the requirements, test methods, inspection rules, signs, packaging, etc. of sodium alginate as raw materials.

This standard applies to the preparation of tissue engineering medical device products and their stent materials sodium alginate.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 191 packaging storage and transportation icon

GB/T 2828.1. Sampling procedures for sampling by sampling - Part 1. Batch-to-batch sampling plan, searched by AQL

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management

YY/T 0313 Requirements for information provided by medical polymer product packaging and manufacturers Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Terms and definitions

The following terms and definitions apply to this document.