|
US$519.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 36988-2018: Guidance for good tissue practice of human origin for tissue engineered medical products
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 36988-2018 | English | 519 |
Add to Cart
|
5 days [Need to translate]
|
Guidance for good tissue practice of human origin for tissue engineered medical products
| Valid |
GB/T 36988-2018
|
PDF similar to GB/T 36988-2018
Basic data | Standard ID | GB/T 36988-2018 (GB/T36988-2018) | | Description (Translated English) | Guidance for good tissue practice of human origin for tissue engineered medical products | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 26,238 | | Date of Issue | 2018-12-28 | | Date of Implementation | 2021-01-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 36988-2018: Guidance for good tissue practice of human origin for tissue engineered medical products
---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.
Guidance for good tissue practice of human origin for tissue engineered medical products
ICS 11.040.40
C45
National Standards of People's Republic of China
Guidelines for the operation of human resources in tissue engineering
Medicalproducts
Published on.2018-12-28
2021-01-01 implementation
State market supervision and administration
China National Standardization Administration issued
Content
Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Requirements 4
4.1 General 4
4.2 Quality System 5
4.3 Personnel 6
4.4 Operating Procedures 7
4.5 Plant Facilities 7
4.6 Environmental Control and Monitoring 7
4.7 Equipment 8
4.8 Materials and Reagents 8
4.9 Qualification Assessment of Donors 9
4.10 Collection of cells and tissues 9
4.11 Processing and Process Control of HCT/Ps 9
4.12 Process Change 10
4.13 Process Verification and Process Simulation 11
4.14 Label Management 11
4.15 Storage 11
4.16 Receiving, pre-shipping and shipping of HCT/Ps 12
4.17 Record 13
4.18 Chasing source 13
4.19 Complaint Document 14
Appendix A (Normative) Guidelines for the Evaluation of Human Cell and Tissue Donor Qualifications 15
Reference 19
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110).
This standard was drafted. China Food and Drug Control Research Institute.
The main drafters of this standard. Meng Shufang, Xu Liming, Wu Yu, Lin Lin, Wu Xueyu, Shao Anliang, Fan Jinping.
Introduction
As a multidisciplinary and emerging field, tissue engineering has developed rapidly in the past two decades, bringing revolutionary innovation to traditional medicine.
New, playing an irreplaceable role in the field of regenerative medicine. The US Food and Drug Administration (FDA) has approved tissue engineered skin
Nearly 10 products such as cartilage are on the market. The State Food and Drug Administration (CFDA) also approved the listing of tissue engineering skin. organization
The industrialization of engineering medical products has begun to take shape. After nearly two decades of development, China’s tissue engineering technology research is close to the international advanced level.
In some areas, even in the international leading position, the research of technical standards is gradually being built.
Human cells and tissues are one of the basic units of tissue engineering products. Compared with other countries, China is marking human cells and tissues.
Quasi-construction is even weaker, as the US FDA issued in.2004 on human cells and tissues and based on cell organization.
Federal regulations for products (21CFR1271HumanCels, Tissues, and CelalandTissue-basedProducts), of which
Part C (DopartC-DonorEligibility) specifies the human donor qualification requirements, Part D (SubpartD-CurrentGood)
TissuePractice) specifies good tissue practices for human cells, tissues and related products. Japan issued a treatment in.2000
And guidelines for using cell tissue products (GeneralPrinciplesfortheHandlingandUseofCelular/T issue-
basedProducts), in.2008, issued guidelines to ensure the quality and safety of human cells, tissue products (Guidelineson
EnsuringQualityandSafetyofHumanCel/T issue-processedProducts). Australia was enacted in.2000
Codeofgood manufacturing process-human blood and tissue, in
Good practice guidelines for human blood, blood components, human tissue and cell therapy products were issued in May.2013 (Codeofgoodmanufac-
Turingpracticeforhumanbloodandbloodcomponents,humantissueandhumanceluartherapyprod-
Ucts). In.2007, China published guidelines related to the processing of cells, tissues and organs that were not equivalent to ASTM standards.
This guideline contains the principle requirements for cells, tissues and organs of the same and heterogeneous origin, not just for human cells and tissues.
As a result, some specific categories of organizational product standards also stipulate relevant requirements, but still show insufficient versatility. So far,
There is still a lack of versatility in the assessment of human donor qualifications, cell and tissue manipulation practices, and evaluation of cell-containing tissue engineering products.
Related standards.
In order to further standardize and promote the development of China's tissue engineering products industry, it is based on the management model of China's pharmaceuticals and medical devices.
The status of research and development and production of tissue engineering products in China, the contents of internationally existing cell and tissue operating practices and ISO related guidelines
As a blueprint, this standard is formulated in conjunction with the relevant requirements of China's pharmaceutical and medical device production quality management standards. Not only for the production of enterprise products
Provide guidance for production and quality management, provide technical support for regulatory authorities to formulate laws and regulations, and clinical transformation and promotion of tissue engineering in China
The process of industrialization development will be of great significance.
Guidelines for the operation of human resources in tissue engineering
1 Scope
This standard specifies the requirements for human cells, tissues and cell-based, tissue-based products (HCT/Ps) in all aspects of production.
Including the establishment of quality systems, facilities, cell and tissue collection, processing, product preservation and transportation, recalls and donor qualification assessment.
This standard applies to the production of human cells, tissues or products based on cells and tissues for tissue engineering. This standard does not apply
For organ transplantation and germ cell manipulation.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 18279.1-2015 Sterilization of ethylene oxide for health care products - Part 1. Development, validation and
General control requirements
GB 18280.1-2015 Sterilizing radiation for health care products - Part 1. Development, validation and routine
Control requirements
YY0033 Sterile medical device production management specification
YY/T 0606.16 Tissue Engineering Medical Products Part 16. Preservation Guide
YY/T 1445-2016 Tissue Engineering Medical Device Product Terminology
ISO 13408-1.2008 Aseptic processing of health care products - Part 1. General requirements (Aseptic processing of health
careproducts-Part 1.Generalrequirements)
ISO 13408-7.2012 Aseptic treatment of health care products - Part 7. Replacement processing of medical devices and combination products (A-
septicprocessingofhealthcareproducts-Part 7.Alternativeprocessesformedicaldevicesandcombi-
Nationproducts)
ISO 14160.2011 Health Products Sterilization of disposable medical devices using animal tissues and their derivatives
Characterization, development, validation and routine control requirements for the sterilization process of therapeutic devices (Sterilization of health care products-Liquid
Chemicalsterilizingagentsforsingle-usemedicaldevicesutilizinganimaltissuesandtheirderivatives-Re-
Requirements for characterization,development,validationandroutinecontrolofasterilizationprocess
Formalicaldevices)
ISO 14937.2000 Development, verification and routine control of the characteristics and disinfection methods of disinfectants for medical devices
General requirements for the system (Sterilizationofhealthcareproducts-Generalrequirementsfor characterizationofa
Sterilingagentandthedevelopment,validationandroutinecontrolofasterilizationprocessformedi-
Caldevices)
ISO 17665-1.2006 Sterilization of health products - Heating in humid air - Part 1. Development and validation of medical equipment
Sterilization process and requirements for its routine control (Sterilization of health care products-Moistheat-Part 1. Re-
Requirementsforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicalde-
Vices)
ISO 18362.2016 Control of microbial risk during manufacturing and processing of cell-based health care products (Manufactureof
cel-basedhealthcareproducts-Controlofmicrobialrisksduringprocessing)
ISO 20857.2010 Requirements for the setting, validation and routine control of sterilization processes for sterilized dry heat medical devices
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 36988-2018_English be delivered?Answer: Upon your order, we will start to translate GB/T 36988-2018_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of GB/T 36988-2018_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 36988-2018_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.
|