AAMI TIR37 pdf free download

AAMI TIR37 pdf free download.Sterilization of health care products—Radiation— Guidance on sterilization of biologics and tissue-based products.
3.2 batch defined quantity of product, intended or purported to be uniform in character and quality, that has been produced during a defined cycle of manufacture. [ANSI/AAMI/ISO TIR1 1 1 39:2006, definition 2.1 ] NOTE For the purposes of this document, a group of tissue products can be described using terms such as donor, processing batch and sterilization batch. 3.3 bioburden population of microorganisms on or in product and/or sterile barrier system. [ANSI/AAMI/ISO TIR1 1 1 39:2006, definition 2.2] 3.4 biologics a preparation that is synthesized from living organisms, or their products, and used as a diagnostic, preventive or therapeutic agent. 3.5 companion tissue tissue from the same donor(s) that is not intended to be used for transplantation. NOTE For the purposes of this document, companion tissue should be processed in the same manner as tissue that is used for transplantation. Companion tissue is representative of tissue intended for transplantation but is only used for evaluation and/or testing purposes.3.6 culture conditions combination of growth media and manner of incubation used to promote germination, growth and/or multiplication of microorganisms NOTE The manner of incubation may include the temperature, time and any other conditions specified for incubation. [ANSI/AAMI/ISO TIR1 1 1 39:2006, definition 2.1 0] 3.7 donor identification unique code assigned to all tissue and companion tissue that originates from the same donor. 3.8 human tissue-based products human cells, tissues, or cellular or tissue-based products (HCT/Ps) articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Examples of HCT/Ps include, but are not limited to, bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue. [FDA 21 CFR 1 271 .3(d)] 3.9 processing any activity performed on an HCT/P other than recovery, donor screening, donor testing, storage, labeling, packaging, or distribution, such as testing for microorganisms, preparation, sterilization, steps to inactivate or remove adventitious agents, preservation for storage, and removal from storage. [FDA 21 CFR 1271 .3(ff)] NOTE For the purposes of this document, cellular-based products are not included. 3.10 processing batch product that has been processed in the same manner and at the same time. NOTE for HCT/Ps, the processing batch is from a single donor source.3.11 processing category group of different product that can be sterilized together. NOTE Processing categories can be based on, for instance, composition, density or dose requirements. [ANSI/AAMI/ISO 1 1 1 37-1 :2006, definition 3.29] 3.12 product family group of different product that can be given the same sterilization dose. [ANSI/AAMI/ISO 1 1 1 37-1 :2006, definition 3.31 ] NOTE the product family is meant solely to determine the sterilization dose based upon bioburden numbers and radiation resistance. 3.13 refrigerant substance placed in the shipping box with the tissue or biologic, intended to maintain a low temperature during the shipping process (e.g., ice packs or dry ice). 3.14 sample item portion SIP defined portion of a health care product that is tested. [ANSI/AAMI/ISO 1 1 1 37-2:2006, definition 3.29]3.16 sterilization batch product to be, or that has been, sterilized at the same time. 3.17 terminal sterilization process whereby product is sterilized within its sterile barrier system. [ANSI/AAMI/ISO TIR1 1 1 39:2006, definition 2.52]AAMI TIR37 pdf download.