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YY/T 0606.9-2007Tissue Engineered Medical Products - Part 9: Sodium Hyaluronate (English PDF)

组织工程医疗产品第9部分：透明质酸钠

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 31, 2007

Implementation date

January 1, 2008

Scope

YY/T 0606.9-2007 is the English-translated version of 组织工程医疗产品第9部分：透明质酸钠.

YY/T 0606.9-2007 is the Chinese pharmaceutical industry standard, Part 9 of the YY/T 0606 series on tissue-engineered medical products, for sodium hyaluronate used to make surgical implants and tissue-engineered products.

It defines hyaluronic acid, classifies the material by source as tissue-extracted or produced by bacterial fermentation, and sets requirements for appearance, glucuronic acid content, pH of a 0.5% solution, intrinsic viscosity as a measure of molecular weight, residual ethanol, dry matter, ash, UV absorption at 260 nm and 280 nm, safety of raw materials and biological evaluation under GB/T 16886.

Test methods, inspection rules, marking, packaging, transport and storage follow, with normative annexes for the analytical methods. Issued on 31 January 2007, it has applied since 1 January 2008.

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Document preview — YY/T 0606.9-2007

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Foreword3
1 Scope4
2 Normative references4
3 Terms and definitions5
4 Classification6
5 Requirements6
6 Test methods9
7 Inspection rules12
8 Marks13
9 Packaging, transportation and storage14
Appendix A15
Appendix B18
Appendix C22
Appendix D25
References28

Foreword

YY/T 0606 Tissue engineered medical products is divided into.

- Part 1: General requirements;

- Part 2: Terminology;

- Part 3: General classification;

- Part 4: Terminology and classification of skin substitute;

- Part 5: Characterization and testing of substrates and scaffolds;

- Part 6: Type I collagen;

- Part 7: Chitosan;

- Part 8: Alginate;

- Part 9: Sodium hyaluronate;

- Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage;

- Part 12: Guide for processing cells, tissues, and organs;

- Part 13: Product conservation;

- Part 16: Guide for gel immobilization or microencapsulation of alginates in the living cells or tissues. This Part is the Part 9 of YY/T 0606.

The Appendixes A, B and C of this Part are normative; while the Appendix D is informative.

1 Scope

This Part of YY/T 0606 specifies the requirements, test methods, testing rules, marks, packaging, transportation and storage of the sodium hyaluronate used in surgical implants and tissue engineered medical products.

This Part applies to the sodium hyaluronate which can be used for preparing the surgical implants and tissue engineered medical products.

2 Normative references

The provisions in the following documents become the provisions of this Part through reference in this Part of YY/T 0606. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Part. However, parties who reach an agreement based on this Part are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest versions apply to this Part.

GB 191-2000 Packaging - Pictorial marking for handling of goods (eqv ISO 780:1997)

GB/T 14518-1993 Determination of the pH of adhesives (neq NFT 76-103.1972)

GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1:1997)

GB/T 16886.3-1997 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (idt ISO 10993-3:1992)

GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4. Selection of tests for interactions with blood (ISO 10993-4:2002, IDT)

GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity (ISO 10993-5:1999, IDT)

GB/T 16886.6-1997 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (idt ISO 10993-6:1994)

GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, IDT)

3 Terms and definitions

The following terms and definitions apply to this Part of YY/T 0606.

3.1 Hyaluronic acid

It refers to the linear polysaccharide that is composed of disaccharide repeating structural units generated by connecting D-glucuronic acid and N-acetyl-D- glucosamine together via beta-(1-3) glucosidic bond.

4 Classification

The sodium hyaluronate can be divided into tissue extraction type and bacterial fermentation type according to the sources of raw materials and preparation methods.

5 Requirements

5.1 Appearance

White or light-yellow powdered or filamentous solid without any visible foreign matters.

5.3 Content of glucuronic acid

>= 40% (mass fraction).

5.4 pH value

The pH value of the solution with the concentration of 0.5% is 6.0~7.5.

5.5 Intrinsic viscosity (molecular weight)

The intrinsic viscosities (molecular weights) of different products shall not be less than their own specified indicated values.

5.9 Residual amount of ethanol

<= 400µg/mg (mass fraction).

5.10 Dry matter content

>= 90% (mass fraction).

5.11 Ash content

<= 10% (mass fraction).

Note: The sodium salt on the hyaluronic acid molecules accounts for 5.7% of total molecular weight.

5.12 UV absorption

OD value at 280nm is <=1.0; OD value at 260nm is <=1.0.

5.15 Safety of raw materials

5.16 Biological properties

5.16.1 General rules

The sodium hyaluronate shall be conducted with biological evaluation according to the requirements specified in the GB/T 16886.1. It shall not release any substances that have adverse effects on the human bodies.

5.16.5 Hemolysis test

There shall be no hemolytic reaction.

5.16.6 Sensitization test

There shall be no skin sensitization.

5.16.7 Subcutaneous implant test

There shall be no significant differences between tissue reaction and negative control, 14 days after implantation.

5.16.8 Genotoxicity test

There shall be no genotoxicity.

6 Test methods

6.1 Appearance

USE naked eyes to observe directly. It shall conform to the provisions specified in the Article 5.1.

6.2 Fourier transform infrared spectroscopy (FT-IR)

USE the potassium bromide tablet method for sample preparation.

6.3 Determination of glucuronic acid content

The determination shall be conducted according to the methods specified in the […]

6.4 Determination of pH value

USE distilled water to prepare the sodium hyaluronate solution with the concentration of 5mg/mL.

6.5 Determination of intrinsic viscosity

The concentration of the sodium hyaluronate solution shall be subject to the delivery time, and shall be controlled within the range of 120s to 180s.

6.6 Determination of dynamic viscosity

USE distilled water and a rotary viscosimeter to prepare the sodium hyaluronate solution with the concentration of 10mg/mL.

6.10 Determination of dry matter content

The determination shall be conducted according to the loss on drying method specified in the Article L in the Appendix VIII of the Pharmacopoeia of People's Republic of China (2005 Edition, Volume 2). It shall conform to the provisions specified in the Article 5.10.

6.13 Sterility test

The determination shall be conducted according to the requirements for sterile operations and the methods specified in the Article H in the Appendix XI of the Pharmacopoeia of People's Republic of China (2005 Edition, Volume 2). It shall conform to the provisions specified in the Article 5.13.

6.15 Test for the safety of raw materials

6.15.1 Hemolysis test for hemolytic streptococcus

USE normal saline to prepare the sodium hyaluronate solution with the concentration of 1mg/mL. TAKE 1mL of sodium hyaluronate solution. Directly INOCULATE on the blood agar culture medium. CULTURE at 37°C for 24h. The test shall conform to the provisions specified in the Article 5.15.1.

6.15.2 Inspection and quarantine

CONDUCT inspection and quarantine for different items, or OBTAIN relevant inspection and quarantine certificate according to different raw materials.

6.16 Biological properties

7 Inspection rules

7.1 General rules

The sodium hyaluronate products fed on the same day with the same production process have the same batch number. The enterprises shall establish appropriate factory inspection items according their own production process.

7.2 Type inspection

8 Marks

8.1 The big-packages shall have the following marks.

8.2 The small packages shall have the following marks.

8.3 The storage and transportation marks shall conform to the provisions specified in the GB/T 191.

9 Packaging, transportation and storage

9.1 USE appropriate packaging to ensure the safety and effectiveness of the sodium hyaluronate products. […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 28 pages — is available in the English PDF.

Referenced standards

Normative references

GB 191-2000

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