YY/T 1571-2017 Tissue engineering medical device products - Sodium hyaluronate
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 is applicable to sodium hyaluronate for the preparation of 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. For undated references, the latest edition of the referenced document (including any amendments) applies.
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)
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)
YY/T 0771.3 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents (YY/T 0771.3-2009, ISO 22442-3:2007, IDT)
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
hyaluronic acid
linear polysaccharide composed of disaccharide repeating structural units formed by D-glucuronic acid and N-acetyl-D-glucosamine linked through β-(1-3) glycosidic bonds, with each disaccharide unit connected to another through β-(1-4) glycosidic bonds
3.2
sodium hyaluronate
sodium salt form of hyaluronic acid, with a relative molecular mass of 401.3 for its structural unit, and its molecular structure formula as shown in Figure 1
Figure 1 Molecular formula of sodium hyaluronate (structural unit)
4 Classification
According to the raw material sources and preparation methods, the preparation process of sodium hyaluronate may be classified into the tissue extraction method and the bacterial fermentation method.
5 Requirements
5.1 Appearance
White or white-like powder, granular or fibrous solid, without any visible foreign matter to the naked eye.
5.2 Identification
The typical Fourier transform infrared spectroscopy (FT-IR) frequencies (cm-1) of sodium hyaluronate are 3 275~3 390 (b), 1 615 (s), 1 405 (m), 1 377 (m), 1 150, 1 077, 1 045 (s), 946 (m), 893 (w). The wavenumber error of the measured absorption bands in the fingerprint region shall be less than ±5 cm-1 (0.5%) of the specified values.
Note: s: strong; m: medium; w: weak; b: broad.
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Test methods
7 Marking
8 Packaging, transportation and storage
Annex A (Normative) Determination of sodium hyaluronate content
Annex B (Normative) Determination of protein content
Annex C (Normative) Determination of ethanol residue (Headspace gas chromatography)
Annex D (Informative) Determination of quaternary ammonium salt (Cetylpyridinium chloride) residue
Annex E (Normative) Determination of weight-average molecular weight and molecular weight distribution
Bibliography
YY/T 1571-2017 Tissue engineering medical device products - Sodium hyaluronate
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 is applicable to sodium hyaluronate for the preparation of 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. For undated references, the latest edition of the referenced document (including any amendments) applies.
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)
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)
YY/T 0771.3 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents (YY/T 0771.3-2009, ISO 22442-3:2007, IDT)
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
hyaluronic acid
linear polysaccharide composed of disaccharide repeating structural units formed by D-glucuronic acid and N-acetyl-D-glucosamine linked through β-(1-3) glycosidic bonds, with each disaccharide unit connected to another through β-(1-4) glycosidic bonds
3.2
sodium hyaluronate
sodium salt form of hyaluronic acid, with a relative molecular mass of 401.3 for its structural unit, and its molecular structure formula as shown in Figure 1
Figure 1 Molecular formula of sodium hyaluronate (structural unit)
4 Classification
According to the raw material sources and preparation methods, the preparation process of sodium hyaluronate may be classified into the tissue extraction method and the bacterial fermentation method.
5 Requirements
5.1 Appearance
White or white-like powder, granular or fibrous solid, without any visible foreign matter to the naked eye.
5.2 Identification
The typical Fourier transform infrared spectroscopy (FT-IR) frequencies (cm-1) of sodium hyaluronate are 3 275~3 390 (b), 1 615 (s), 1 405 (m), 1 377 (m), 1 150, 1 077, 1 045 (s), 946 (m), 893 (w). The wavenumber error of the measured absorption bands in the fingerprint region shall be less than ±5 cm-1 (0.5%) of the specified values.
Note: s: strong; m: medium; w: weak; b: broad.
Contents of YY/T 1571-2017
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Test methods
7 Marking
8 Packaging, transportation and storage
Annex A (Normative) Determination of sodium hyaluronate content
Annex B (Normative) Determination of protein content
Annex C (Normative) Determination of ethanol residue (Headspace gas chromatography)
Annex D (Informative) Determination of quaternary ammonium salt (Cetylpyridinium chloride) residue
Annex E (Normative) Determination of weight-average molecular weight and molecular weight distribution
Bibliography
