YY/T 1571-2017Tissue engineering medical device products—Sodium hyaluronate (English PDF)

Foreword

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

This Standard replaces YY/T 0606.9-2007, Tissue engineered medical products - Part 9: Sodium hyaluronate. Compared with YY/T 0606.9-2007, the major technical changes are as follows.

-- Change the standard name to Tissue engineering medical device products - Sodium hyaluronate;

-- Delete the normative references of YY/T16886 series (only reserve YY/T 16886.1) (see Chapter 2; Chapter 2 of the 2007 edition);

-- Add the normative references YY/T 0771.1 ~ 0771.3, Medical devices utilizing animal tissues and their derivatives (see Chapter 2);

-- Revise the edition year number of "Pharmacopeia of the People's Republic of China" in the normative references (see Chapter 2; Chapter 2 of the 2007 edition);

-- Modify the molecular formula (structural unit) of sodium hyaluronate (see 3.2; 3.2 of the 2007 edition);

-- Modify the requirements and test methods for sodium hyaluronate content (see 5.3, 6.3 and Appendix A; 5.3, 6.3 and Appendix A of the 2007 edition);

-- Modify the requirements for intrinsic viscosity and the molecular weight symbol M in the formula of the test method (see 5.5, 6.5; 5.5, 6.5 of the 2007 edition);

-- Delete the requirements and test methods for dynamic viscosity (see 5.6 and 6.6 of the 2007 edition);

-- Modify the test method for protein content (see 6.6 and Appendix B; 6.7 and

Appendix B of the 2007 edition)

-- Add the requirements and test methods for nucleic acids (see 5.7 and 6.7);

-- Modify the test method for heavy metal content (see 6.8; 6.8 of the 2007 edition);

-- Modify the requirements and test methods for residual ethanol (see 5.9, 6.9 and Appendix C; 5.9, 6.9 and Appendix C of the 2007 edition);

-- Delete the requirements and test methods for ash content (see 5.11 and 6.11 of the 2007 edition);

-- Delete the requirements and test methods for ultraviolet absorption (see 5.12 and 6.12 of the 2007 edition);

-- Modify the requirements and test methods for dry matter content (see 5.10, 6.10; 5.10, 6.10 of the 2007 edition);

-- Add the requirements and test methods for quaternary ammonium salt residues (see 5.11, 6.11 and Appendix D);

-- Add the requirements and test methods for sulfated mucopolysaccharides (see 5.12 and 6.12);

-- Add the requirements and test methods for iron content (see 5.13 and 6.13);

-- Add the requirements and test methods for chlorides (see 5.14 and 6.14);

-- Add the requirements and test methods for weight-average molecular weight and molecular weight distribution coefficient (see 5.15, 6.15 and Appendix E);

-- Add the requirements and test methods for the clarity and color of solution (see 5.16 and 6.16);

-- Add the requirements and test methods for microbial limit (see 5.18, 6.18);

-- Modify the requirements and test methods for bacterial endotoxin limit (see 5.19, 6.19; 5.14, 6.14 of the 2007 edition);

-- Modify the requirements and test methods for raw material safety (see 5.20, 6.20, 6.21; 5.15, 6.15 of the 2007 edition);

-- Delete the specific requirements and test methods for biological evaluation, only retaining the general principles (see 5.21; 5.16 and 6.16 of the 2007 edition);

-- Delete Chapter 7 Inspection rules (see Chapter 7 of the 2007 edition);

-- Delete the background information of Appendix D (see Appendix D of the 2007 edition);

-- Add the references "Guiding Principles for Registration and Declaration of Medical Device Products Utilizing Animal Tissues and Their Derivatives" and European Pharmacopoeia (see References);

-- Modify the version number of the reference ASTM F2347-03 (see References; References of the 2007 edition).

1 Scope

This Standard specifies the requirements and test methods for sodium hyaluronate used in surgical implants and tissue engineering medical device products.

This Standard applies to the preparation of sodium hyaluronate for tissue engineering medical device products and their scaffold materials.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies to this document. For undated references, the latest edition (including any amendment) applies to this document.

GB/T 191, Packaging - Pictorial marking for handling of goods

GB/T 14518, Determination of the pH of adhesives

GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1:2009, IDT) A linear polysaccharide that is composed of disaccharide repeating structural units of D-glucuronic acid and N-acetyl-D-glucosamine linked by beta-(1-3) glycosidic bonds.

GB 18278 (all parts), Sterilization of health care products - Moist heat

GB 18279 (all parts), Sterilization of health care products - Ethylene oxide

GB 18280 (all parts), Sterilization of health care products - Radiation

YY/T 0313, Medical polymer products - Requirement for package and information supplied by manufacturer

YY/T 0606.25, Tissue engineered medical product - Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives. Fluorescence method

YY/T 0771.1, Medical devices utilizing animal tissues and their derivatives - Part 1. Application of risk management (YY/T 0771.1-2009, ISO 22442-1:2007, IDT)

YY/T 0771.2, Medical devices utilizing animal tissues and their derivatives - Part 2.

Controls on sourcing, collection and handling (YY/T 0771.2-2009, ISO 22442- 2.2007, IDT)

3 Terms and definitions

The following terms and definitions are applicable to this document.

4 Classification

The preparation process of sodium hyaluronate can be divided into tissue extraction method and bacterial fermentation method according to different raw material sources and preparation methods.

5 Requirements

6 Test methods

7 Marking

7.1 The outer package shall have the following markings.

7.2 The small package shall have the following markings.

7.3 The storage marking shall comply with the provisions given in GB/T 191.

Note. Refer to the graphic symbols given in YY 0466.1, which shall meet the above requirements.

8 Packaging, transportation and storage

8.1 Packaging shall be appropriate, to ensure the safety and effectiveness of sodium hyaluronate products.