YY/T 0513.1-2019Allogeneic grafts - Part 1: The basic requirements for tissue bank (English PDF)

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).

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 document. 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.