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YY/T 0513.1-2019: Allogeneic grafts -- Part 1: The basic requirements for tissue bank
Status: Valid YY/T 0513.1: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0513.1-2019 | English | 239 |
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Allogeneic grafts -- Part 1: The basic requirements for tissue bank
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YY/T 0513.1-2019
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| YY/T 0513.1-2009 | English | 439 |
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Allogeneic bone grafts. Part 1: The basic requirements for bone bank
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YY/T 0513.1-2009
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Basic data | Standard ID | YY/T 0513.1-2019 (YY/T0513.1-2019) | | Description (Translated English) | Allogeneic grafts -- Part 1: The basic requirements for tissue bank | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 12,160 | | Date of Issue | 2019 | | Date of Implementation | 2020-10-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the basic requirements for the quality management of tissue banks, and specifies the whole process of allogeneic tissue banks from informed consent or authorization, donor applicability assessment, and tissue product collection, processing, packaging, labeling and distribution. This standard applies to the operation of allogeneic tissue banks and the quality control of their products. | YY/T 0513.1-2019: Allogeneic grafts -- Part 1: The basic requirements for tissue bank---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.
Allogeneic grafts-Part 1. The basic requirements for tissue bank
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Replaces YY/T 0513.1-2009
Allogeneic repair material
Part 1. Basic requirements for organization libraries
Published on October 23,.2019
2020-10-01 implementation
Published by the State Drug Administration
Foreword
YY/T 0513 `` Allogeneic Repair Materials '' is divided into the following 3 parts.
--- Part 1. Basic requirements for the organization library;
--- Part 2. Deep hypothermic frozen bone and freeze-dried bone;
--- Part 3. Demineralized bone.
This part is the first part of YY/T 0513.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY/T 0513.1-2009 "Allogeneic bone repair materials Part 1. Basic requirements for bone tissue bank", and
Compared with YY/T 0513.1-2009, in addition to editorial changes, the main technical changes are as follows.
--- The standard name was changed to "Allogeneic Repair Materials Part 1. Basic Requirements for Tissue Banks" (see the title of the homepage and the standard text)
Title, title of the.2009 version of the front page and standard text);
--- Removed the introduction (2009 introduction);
--- Further clarified the scope of application of this section to adapt to current management regulations, and supplemented the applicable existing product categories
In addition, it is listed as a "note" to explain the scope of application (see Chapter 1, Chapter 1 of the.2009 edition);
--- Added applicable standards for normative references (see Chapter 2, Chapter 2 of the.2009 edition);
--- Revised the term "bone tissue bank" to "tissue bank" and redefined it, and added the definition of "donor, production batch, product batch" to clarify
Confirm the basic concepts (see Chapter 3, Chapter 3 of the.2009 edition);
--- Modified the "4 bone tissue bank organization form and personnel" to "4 tissue bank quality management system", all subsequent ones involving "bone group
The term "weaving library" has been revised to "organization library". Based on the quality system standards and regulations, the internals of the quality system have been clarified and improved.
Content; according to the elements of the quality system, combined with the characteristics of the organizational library, re-listed and stipulated the requirements for each quality link. "4.1
"Management Committee shall be established" was revised to "4.2.2 Organizing Bank Manager"; "4.2.3 Manager Representative" and "4.3 Document Control" were added
"4.4 Quality Internal Audit" (see Chapter 4, Chapter 4 of the.2009 edition);
--- Divide the "5 production and process control" clauses into "5 infrastructure control" and "6 production process control" clauses. Based on "5
The “facility control” clause has refined and standardized the requirements for production facilities, testing facilities, and storage facilities (see Chapters 5 and 6
(Chapter 5,.2009 edition);
--- In the revised "6 Production Process Control" clause, management and specification requirements for all aspects of production have been added (see Chapter 6,
Chapter 5 of the.2009 edition);
--- Added "7 Quality Control" (see Chapter 7);
--- Modified the "5.7 Recognition of Bone Tissue Acquisition" to "8 Acquisition of Allogeneic Tissue". Removed donor medical history requirements
"5.8.8 The above-mentioned tissues of living sources shall be placed in a separate storage box", adding "h) Others. according to the characteristics of different tissues
Corresponding Medical History Requirements "; revised" 5.11 Donor Test Requirements "to" 8.4.3 Serological Tests ", replacing the content of the original" Note "with"
"Living donors should be tested for hepatitis B virus core antibodies" mentioned in the text of condition e); at the same time, "Note. if not
Live donors can be tested with validated methods using extracts or extracts from their tissue materials "; increased tissue yield
Environmental requirements and transport and reception requirements (see Chapter 8, 5.7 of the.2009 edition);
--- Added "9 Organizational Processing" clauses (see Chapter 9);
--- Modified the "6 tags control" to "10 tags and labels" and added the requirements of "10.3 Product Manual" (see Chapter 10,
Chapter 6 of the.2009 edition);
--- Amended the "7 packaging control" to "11 packaging control", added "the final sterilized medical device packaging can refer to GB/T 19633,
Requirement of YY 0236 "; Removed the requirement that there should be product instructions in the 7.5 package (see Chapter 11, Chapter 7 of the.2009 edition);
--- Modified "9.2 Reuse" to "14 Disposal Organizations for Disposal" (see Chapter 14, see 9.2 in.2009)
--- Added the content of product traceability requirements (see Chapter 15, Chapter 9 of the.2009 edition);
--- Added the content of the product recall procedure and improved the presentation (see Chapter 17, Chapter 9 of the.2009 edition);
--- Amended the "9 adverse reaction report system" to "18 adverse event reports", deleted the sub-items under it. Added "Medical
Citations for the management of device adverse event monitoring and re-evaluation "(see Chapter 18, see Chapter 9 of the.2009 edition);
--- Updated the bibliography, supplemented the current regulations and the new version of the American Organizational Bank Association (AATB) Organizational Library Standard (see References
Literature,.2009 edition references);
--- Deleted "Maintenance of 10 Bone Tissue Bank Quality Management System", and related content was merged into "7 Quality Control" (see Chapter 7,.2009
Chapter 10).
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This section is proposed by the State Drug Administration.
This section is under the jurisdiction of the China Food and Drug Administration.
This section was drafted. General Hospital of the Chinese People's Liberation Army, Shanxi Medical Organization Bank, China Food and Drug Testing Institute.
The main drafters of this section. Lu Shizhang, Guo Quanyi, Zhao Yaping, Xu Liming, Peng Jiang, Xu Wenjing, Shao Anliang, Zhao Shichong, Xian Hai, Feng Xiaoming,
Wu Tingfei.
Allogeneic repair material
Part 1. Basic requirements for organization libraries
1 Scope
This part of YY/T 0513 specifies the basic requirements for the quality management of the tissue bank.It requires informed consent or authorization,
Donor applicability assessment, and organization of product collection, processing, packaging, labeling, and distribution of the whole process of activities are regulated.
This section applies to the operation of allogeneic tissue bank and its product quality control.
Note. Tissue bank products mainly include allogeneic bone tissue (freeze-dried bone, deep hypothermic frozen bone), bone joints and attached tissue (such as cartilage, meniscus, etc.),
Allogeneic soft tissue (tendon/ligament, nerve, membrane tissue, skin, etc.) and the above-mentioned tissue-derived components (such as demineralized bone, acellular tissue), etc.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 16292 Test method for suspended particles in clean room (area) of pharmaceutical industry
GB/T 16293 Test method for plankton in clean room (area) of pharmaceutical industry
GB/T 16294 Test method for sedimentary bacteria in clean room (area) of pharmaceutical industry
GB/T 19633.1 Packaging of final sterilized medical devices. Part 1. Requirements for materials, sterile barrier systems and packaging systems
YY 0033 Specification for production management of sterile medical devices
YY 0236 Compound film for pharmaceutical packaging (general rules)
YY/T 0287 Medical device quality management system for regulatory requirements
Pharmacopoeia of the People's Republic of China (2015 Edition)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Tissuebank
Institutions engaged in screening donors, obtaining, processing, inspecting, storing, and distributing tissue products for clinical transplantation/implantation treatment.
3.2
Donor donor
Donors who provide allogeneic tissues.
3.3
Production lot
A certain number of products from the same donor, produced at the same time and on the same production line, with the same properties and quality.
3.4
Product batch
Produced from the same donor and continuously produced in the same processing cycle and under the same process conditions.
Number of products.
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