EATB

Glossary of Terms



  • Allocation criteria: a set of criteria to ensure that recipients get equitable access to healthcare of appropriate quality for all, in which potential recipients get a ranking order on the basis of relevant medical urgency criteria (including waiting time).
  • Allogeneic use: cells or tissues removed from one person and applied to another (2004/23/EC).
  • Aseptic processing: processing is performed under clean room conditions. No terminal sterilisation that sterilises all product or package components is carried out (EATB 2003).
  • Audit: a documented review of procedures, records, personnel functions, equipment, materials, facilities and/or vendors in order to evaluate adherence to written SOPs, standards or government laws and regulations (CoE Guide 2004).
  • Autologous use: cells or tissues removed from and applied to the same person (2004/23/EC).
  • Batch (see also Lot): a defined quantity of tissue produced according to a single processing cycle during the same processing cycle which is intended to have uniform character and quality within specific limits, precluding mixing of cells and/or tissue from two or more donors (EATB 2003).
  • Bioburden: population of viable micro-organisms found on a given amount of material (EATB 2003).
  • Calibration: the set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard (EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice).
  • Cells: individual human cells or a collection of human cells when not bound by any form of connective tissue (2004/23/EC).
  • Clean, non sterile: use of methods and techniques that keep microbial contamination of the tissues collected at a minimum level (EATB 2003).
  • Clean-room technology: as all the technical and procedural actions required to control microbial and particulate contamination in work areas, and maintain predetermined levels of contamination (EATB 2003).
  • Competency: the ability of an employee to acceptably perform tasks for which he/she has been trained (AATB Standards 11th edition).
  • Complaint: any written or oral communication concerning dissatisfaction with the identity, quality, packaging, durability, reliability, safety, effectiveness, or performance of cells and/or tissue (AATB Standards 11th edition).
  • Cost: the actual costs for retrieval, processing, preservation, storage, distribution, education, research and development (EATB 2003).
  • Critical: means potentially having an effect on the quality and/or safety of having contact with the cells and tissues (2006/86/EC). Having an effect on fundamental requirements for quality and safety, thus (potentially) endangering the safety of recipients or personnel of the TE.
  • Demineralised bone: implant made from osseous tissue with a measurable residual below 5 % in its calcified intercellular calcium substances (Standards of Tissue Banking, American Association of Tissue Banks, 1990).
  • Direct use: any procedure where cells are donated and used without any processing and banking (2006/17/EC).
  • Disinfection: a process reducing the number of viable microorganisms, but does not insure the complete destruction of microbial forms, such as spores and viruses (EATB 2003).
  • Distribution: transportation and delivery of tissues or cells intended for human applications (2004/23/EC).
  • Donation: donating human tissues or cells intended for human applications (2004/23/EC).
  • Donor: every human source, whether living or deceased, of human cells or tissues (2004/23/EC).
  • Donor: live donor: any donor who has not undergone brain death (EATB 2003).
  • Donor: deceased donor: any donor who has undergone brain death or cardiac death (EATB 2003).
  • Donor of surgical residues: any donor where organs, tissues or cells are collected during a surgical procedure where the material is removed for therapeutic purposes other than to obtain organs, tissues, or cells (CoE Guide 2004).
  • Dura mater: a type of soft tissue that includes the pachymeninx (thick, membranous) tissue covering the brain (AATB Standards 11th edition).
  • End user: facility, or medical practitioner who performs transplantation procedure (EATB 2003).
  • Error: a departure, whether intentional or not, from the SOPM, standards, or applicable federal, state, and/or local laws and/or regulations during donor screening, testing, retrieval, processing, quarantine, labelling, storage, distribution, or dispensing of cells and/or tissues which may cause infectious disease transmission, adversely affect the clinical performance of cells and/or tissue, and/or interfere with the ability to trace cells and/or tissue to the donor (AATB Standards 11th edition).
  • Exceptional release: the dispensing of a unit of cells and/or tissue, because of an unusual clinical need, which circumvents normal release procedures. This requires written approval from both the Medical Director and the transplanting physician (AATB Standards 11th edition).
  • Expiry date: the date after which tissues or cells are no longer suitable for use (CSA 2003).
  • Facility: any area used in the procurement, processing, testing, storage or distribution of tissues/cells (CoE Guide 2004).
  • Finished tissue: cells and/or tissue that have been fully processed, enclosed in its final container, labelled and released to distribution inventory (AATB Standards 11th edition).
  • Freeze-dried tissue (synonym: lyophilised): achieved by freezing tissue in such a way that water is converted into ice in situ and subjected thereafter to a vacuum sufficient to facilitate sublimation of the ice thus formed (CoE Guide 2004).
  • Good Manufacturing Practice (GMP): a quality assurance scheme, which ensures that medicinal products are consistently produced and controlled to quality standards (UK HTA Code of Practice Draft, 2006).
  • Graft transplant material: the result of a series of operations including collection, processing, testing and package, ready to be delivered and used by the medical practitioner (CoE Guide 2004).
  • Harm: physical injury and/or damage to health and property (ISO/CD 14971 Medical Devices and Risk Management - Application of Risk Management to Medical Devices.)
  • Hazard: potential source of harm. (ISO/CD 14971 Medical Devices and Risk
  • Management - Application of Risk Management to Medical Devices).
  • Human application: the use of tissues or cells on or in a human recipient and extracorporal applications (2004/23/EC).
  • Informed consent: a procedure whereby information concerning the donation process is presented to the donor or donor’s next of kin with an opportunity for them to ask questions, after which specific approval is documented (AATB Standards 11th edition).
  • Label: a display of written, printed or graphic matter upon the immediate container of any article (US Food and Drug Administration (FDA) Guidance Document The Federal Food, Drug and Cosmetic (FD&C) Act, Section 201 (k)).
  • Lot (see also Batch): cells and/or tissue produced from one donor at one time using one set of instruments and supplies. Also refers to a quantity of reagents, supplies, or containers that is processed or manufactured at one time and identified by a unique identification number recipient.
  • Major non-conformity: if it poses a potential or indirect threat to the safety of a donor, recipient or staff member.
  • Medical clinician: person licensed by a country to practice the healing arts within its jurisdiction (EATB 2003).
  • Minor non-conformity: if it poses a minimal but not significant risk.
  • Next of kin: the person(s) most closely related to a deceased individual as designated by applicable law such as the Uniform Anatomical Gift Act (AATB Standards 11th edition).
  • Non-conformity: non compliance with the specified requirements (EATB 2003).
  • Organ: a differentiated and vital part of the human body, formed by different tissues, which maintains its structure, vascularisation and capacity to develop physiological functions with a significant level of autonomy (2004/23/EC).
  • Organisations responsible for human application: a health care establishment or a unit of a hospital or another body which carries out human application of human tissues and cells (2006/86/EC).
  • Partner donation: the donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship (2006/86/EC).
  • Pooling: the physical contact or mixing of cells or tissues from two or more donors in a single container (CoE Guide 2004).
  • Preservation: the use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of cells or tissues (2004/23/EC).
  • Procedure: a series of technical steps precisely followed in a defined order (EATB 2003).
  • Processing: all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications (2004/23/EC).
  • Procurement: a process by which tissue or cells are made available (2004/23/EC).
  • Procurement organisation: a health care establishment or a unit of a hospital or another body which undertakes the procurement of human tissues and cells and which may not be accredited, designated, authorised or licensed as a tissue establishment (2006/86/EC).
  • Product recall: to request from distribution any product which may be related to an adverse event or reaction. The request to return a tissue or batch to a tissue establishment due to the discovery of a safety issue.
  • Quality: the conformance of a tissue or process with pre-established specifications or Standards (AATB Definitions 2000).
  • Quality assurance: all those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality (CoE Guide 2004).
  • Quality control: the operational techniques and activities that are used to fulfil requirements for quality (EATB 2003).
  • Quality control: specific tests defined by the Quality Assurance Program to be performed in order to monitor retrieval, processing, preservation and storage, tissue quality and test accuracy. These may include but are not limited to: performance evaluation, Testing and controls used to determine the accuracy and reliability of the tissue bank’s equipment and operational procedures as well as the monitoring of supplies, reagents, equipment and facilities (AATB Definitions, 2000).
  • Quality management: the coordinated activities to direct and control an organisation with regard to quality (2006/86/EC).
  • Quality system: the organisational structure, defined responsibilities, procedures, processes and resources for implementing quality management; includes all activities which contribute to quality, directly or indirectly (2006/86/EC).
  • Quarantine: the status of retrieved tissue or cells, or tissue isolated physically or by other effective means, whilst awaiting a decision on their acceptance or rejection (2004/23/EC).
  • Recall: an action taken by a tissue bank to locate and retrieve cells and/or tissue from distribution and dispensary inventories (AATB Standards 11th edition).
  • Recipient: the person into whom an organ, tissue or cells is/are grafted/implanted (CoE Guide 2004).
  • Reimbursement: a payment of money equal to, but not exceeding, expenses necessarily incurred (EATB 2003).
  • Reproductive cells: all tissues and cells intended to be used for the purpose of assisted reproduction (2006/86/EC).
  • Residual moisture: the ratio of the mass of residual water to the mass of lyophilizate (EATB 2003).
  • Residual water: content is less than 6 % by gravimetric analysis (CoE Guide 2004).
  • Responsible person: a person who is authorized to perform designated functions for which he or she is trained and qualified (AATB Standards 11th edition).
  • Retrieval: the procurement, harvesting or collection of transplantable tissues or cells, whether viable or not, from a living or non-living donor, for the benefit of one or more patients (EATB 2003).
  • Risk: the probability of a hazard causing harm and the degree of severity of the harm (ISO/CD 14971 Medical Devices and Risk Management - Application of Risk Management to Medical Devices).
  • Risk analysis: investigation of available information to identify hazards and estimate risk (ISO/CD 14971 Medical Devices and Risk Management - Application of Risk Management to Medical Devices).
  • Safety: freedom from unacceptable risk of harm (ISO/CD 14971 Medical Devices and Risk Management - Application of Risk Management to Medical Devices).
  • Serious adverse event: any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity (2004/23/EC).
  • Serious adverse reaction: an unintended response, including a communicable disease, in the donor or in the recipient, associated with the procurement or human application of tissues and cells, which is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity (2004/23/EC).
  • Standards: specifications, requirements and procedures applicable to donor screening, tissue procurement, testing, processing, storage and distribution designed to ensure the continued purity, potency, clinical efficacy and safety of such tissues during the dating period (EATB 2003).
  • Standard Operating Procedures (SOPs): written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product (2006/86/EC).
  • Sterilisation: a validated physical or chemical process to destroy, inactivate or reduce microorganisms to a sterility assurance level of 10-6 (CoE Guide 2004).
  • Storage: maintaining the product under appropriate controlled conditions until distribution (2004/23/EC).
  • Surgical residues: collection of tissues/cells during a surgical procedure where the material is removed for therapeutic purposes other than to obtain organs, tissues, or cells (CoE Guide 2004).
  • Terminal sterilisation: a validated process whereby tissue is sterilized within its primary packaging (AATB Standards 11th edition).
  • Tissue: all constituent parts of the human body formed by cells (2004/23/EC). Human tissue includes all constituted parts of a human body formed by cells including surgical residues and amnion, but excluding organs, blood and blood products. New products engineered from human tissue are included (EATB 2003).
  • Tissue container: wrapping system insuring the integrity and sterility of tissues (CoE Guide 2004).
  • Tissue establishment (TE): a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells (2004/23/EC).
  • Tissue package: additional wrapping used to protect one or more tissue containers during transit (EATB 2003).
  • Traceability: the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s); traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells (2006/86/EC).
  • Validation (or ‘qualification’ in the case of equipment or environments): establishing documented evidence that provides a high degree of assurance that a specific process, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use (2006/86/EC).