|
US$439.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0606.25-2014: Tissue engineered medical product. Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
Status: Obsolete
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0606.25-2014 | English | 439 |
Add to Cart
|
3 days [Need to translate]
|
Tissue engineered medical product. Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
| Obsolete |
YY/T 0606.25-2014
|
PDF similar to YY/T 0606.25-2014
Basic data | Standard ID | YY/T 0606.25-2014 (YY/T0606.25-2014) | | Description (Translated English) | Tissue engineered medical product. Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 11,173 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | PRC Pharmacopoeia 2010 edition (Volume 3) | | Adopted Standard | PRC Pharmacopoeia 2010 edition (Volume 3) | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to biological materials of animal origin and their derivatives of the final product or intermediate products, tissue engineered medical products of animal origin matrix or scaffold scaffold. The standard test method for the quantitat | YY/T 0606.25-2014: Tissue engineered medical product. Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Tissue engineered medical product.Part 25. Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives. Fluorescence method
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Tissue Engineered Medical Products Part 25.
Biological material of animal origin residues in DNA assays.
Fluorescent staining
Tissueengineeredmedicalproduct-Part 25.
tissuesandtheirderivatives. Fluorescencemethod
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
YY/T 0606 "tissue-engineered medical products" have or plan to release the following sections.
--- Part 2. Terminology;
--- Part 3. General classification;
--- Part 4. skin substitute (object) of the terminology and classification;
--- Part 5. Matrix and stent performance and testing;
--- Part 6. Ⅰ collagen;
--- Part 7. chitosan;
--- Part 8. sodium alginate;
--- Part 9. sodium hyaluronate;
--- Part 10. In vivo evaluation of the repair or regeneration of articular cartilage implants;
--- Part 12. cells, tissues, organs processing guide;
--- Part 13. automatic cell counting;
--- Part 14. Test methods and evaluation matrix scaffold immune response. ELISA method;
--- Part 15. Test method for evaluating the immune response matrix and bracket. Lymphocyte proliferation assay;
--- Part 16. Saving Guide;
--- Part 17. exogenous factor evaluation guidelines;
--- Part 18. alginate gel or microencapsulated fixed guide;
--- Part 19. Repair and replacement of bone tissue implant bone formation activity in vivo evaluation guidelines;
--- Part 20. Test methods and evaluation matrix scaffold immune response. cell migration test;
--- Part 24. resorbable biomaterial implant evaluation test specification;
--- Part 25. materials of animal origin DNA residues in biological assays. Fluorescence staining;
--- Part 26. polymer scaffold microstructure evaluation guidelines.
This section YY/T 0606 Part 25 of.
This section Press GB/T 1.1-2009 given rule drafting.
Please note that some of the content of this section may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the jurisdiction of the Chinese Institute of Food and Drug test.
This section drafted by. Chinese Academy of Food and Drug test.
The main drafters of this section. Xu Liming, Chen Liang, Shao Anliang.
Introduction
Trauma derived from biological scaffold mammalian extracellular matrix is composed of commonly used surgical repair, tendon, skin, cardiovascular,
Gastrointestinal and lower urinary tract tissue reconstruction. Various tissues outside the extracellular matrix scaffold drawn from humans and animals, such as. pig skin, cornea,
Small intestine, bladder and urethra, cow skin, human skin, etc. Since the cell membrane antigen epitope, allogeneic or heterologous DNA as well as by the loss
Small molecules may cause injury from a wide range of human immune response, so the process of animal origin acellular matrix material is believed to be
very important. Although the extracellular matrix material has been widely used in clinical, but there are still due to residual DNA and residual proteins, etc.
Inflammation and immune response induced hazards. Thus, the biological material of animal origin, the residual DNA quantitation is a weight control product quality
To one of the measures. At present, no international standard method for detecting residues of the products of DNA. US FDA nor animal
Specific provisions derived biological material remains limited amount of DNA. The use of animal-derived biomaterials for medical devices to become an animal source of medical equipment.
International Organization for Standardization issued a series of animal source of medical equipment standard (ISO 22442-1.2007), China was in 2008, converted to equivalent
"Animal source of medical equipment" industry standard. This standard includes Part 1 "Risk Management"; Part 2 control "source, collection and disposal
System "; Part 3" of viruses and transmissible spongiform encephalopathy (TSE) to confirm the removal and inactivation of factors. "In 2009 China promulgated the" Animal
Derived medical device product registration dossier Guidelines "(Food and Drug Administration Office of armed Han [2009] No. 519). Medical device products of animal origin
Registration dossier requirements mentioned in the registration dossier on the basis of meeting the general requirements, the need to increase relates to control of viral and/or
Contagious pathogen infection and related technical content immunogenicity risk. Wherein the request to remove (or reduce) materials of animal origin
Description immunogenicity process, quality control indicators and confirmatory experimental data or related information. For materials of animal origin brought by Free
Reduce immunogenicity risk, the general approach to reduce their immunogenicity in the production process, including off the cells, remove contaminating proteins, as well as to make egg
Denaturation and other physical and/or chemical processing steps, remove or cover epitopes. Production companies need to reduce their immunogenicity material
The validity for verification. One of means of verification is to detect the residual DNA content. Biological agent detection method based on residual DNA
Including DNA probe hybridization and fluorescence staining ( "People's Republic of China Pharmacopoeia" 2010 edition three, IX-B Appendix exogenous
DNA residues in assay), where easy staining operation, high sensitivity, good reproducibility, are widely used. however.
a) biological material of animal origin derived from animal or human tissues (mainly the stromal tissue), and other cell-depleted process is made mostly
A solid state (some for the gel or liquid state), can not be directly detected by the above method;
b) stromal tissue contains large amounts of structural proteins, affect the outcome of the fluorescence assay.
Therefore, biologics residual DNA detection method can not be directly used for quantitative detection of biological material of animal origin residual DNA. The standard
Brigadier elaborate animal biological material suitable for the quantitative detection of residual DNA.
Tissue Engineered Medical Products Part 25.
Biological material of animal origin residues in DNA assays.
Fluorescent staining
1 Scope
YY/T 0606 This section applies to animal biological material and its derivatives final products or intermediate products for tissue engineering Medical
Spa products of animal origin scaffold matrix or scaffold can also be used for human-derived materials.
This part of the test method for the quantitative detection of residual DNA biological material of animal origin. Sample to be tested for residues in DNA
The detection result in the detection sensitivity of the method of the effective portion. Is set for each particular sample, test conditions whether co
Treatment requires appropriate method validation. In addition to this standard selection methods, may adopt other equivalent method.
Implementation of this part of the user shall establish appropriate safety and health regulations, and the applicability of the provisions of the regulations.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
People's Republic of China Pharmacopoeia 2010 edition three
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Matrix matrix
Tissue-engineered medical products as the growth of cells or biomolecules, support or delivery vehicle of raw materials, which can be a polymer composition
Quality, or it may be the biological tissue extracellular matrix (Matrix) substances derived from biological origin.
3.2
Bracket scaffold
Alternative, repair or regeneration of tissue cells or biologically active factors migration, binding or transporting a support, carrier or matrix release.
Many organic compounds (biogenic substances), inorganic and polymeric substances can be used as tissue engineering scaffolds medical products.
3.3
Animal animal
Spine or any invertebrate [including amphibians, arthropods (eg crustaceans), birds, coral, fish, reptiles, molluscs
Matter and mammals], does not include people (Homo sapiens).
3.4
Derivatives derivates
Substance obtained by the manufacturing process from animal-derived materials. For example. hyaluronic acid, collagen, gelatin, monoclonal antibody, chitosan, white
Protein.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0606.25-2014_English be delivered?Answer: Upon your order, we will start to translate YY/T 0606.25-2014_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 0606.25-2014_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0606.25-2014_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|