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ASTM F 2739 : 2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
Available format(s)

Hardcopy , PDF

Superseded date

31-01-2020

Language(s)

English

Published date

01-10-2016

This guide is a resource of cell viability test methods that can be used to assess the number and distribution of viable and non-viable cells within porous and non-porous, hard or soft biomaterial scaffolds, such as those used in tissue-engineered medical products (TEMPs).

1.1This guide is a resource of cell viability test methods that can be used to assess the number and distribution of viable and non-viable cells within porous and non-porous, hard or soft biomaterial scaffolds, such as those used in tissue-engineered medical products (TEMPs).

1.2In addition to providing a compendium of available techniques, this guide describes materials-specific interactions with the cell assays that can interfere with accurate cell viability analysis, and includes guidance on how to avoid, and/or account for, scaffold material/cell viability assay interactions.

1.3These methods can be used for 3-D scaffolds containing cells that have been cultured in vitro or for scaffold/cell constructs that are retrieved after implantation in living organisms.

1.4This guide does not propose acceptance criteria based on the application of cell viability test methods.

1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Committee
F 04
DocumentType
Guide
Pages
7
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

17/30341492 DC : 0 BS ISO 20391-1 - BIOTECHNOLOGY - CELL COUNTING - PART 1: GENERAL GUIDANCE ON CELL COUNTING METHODS
ASTM F 3225 : 2017 Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
ISO 20391-1:2018 Biotechnology — Cell counting — Part 1: General guidance on cell counting methods
ASTM F 3163 : 2016 Standard Guide for Classification of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
DIN ISO 13022 E : 2014 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
ASTM F 2997 : 2013 Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis
DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
ASTM F 2903 : 2011 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
ASTM F 3206 : 2017 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
ASTM F 3088 : 2014 Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions
ASTM F 3223 : 2017 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
ASTM F 3268 : 2018 : REV A Standard Guide for <emph type="bdit">in vitro</emph> Degradation Testing of Absorbable Metals
ASTM F 561 : 2019 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
10/30203224 DC : 0 BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
ANSI/AAMI/ISO 13022:2012 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
ASTM F 3268 : 2018 Standard Guide for <emph type="bdit">in vitro</emph> Degradation Testing of Absorbable Metals

ASTM F 2149 : 2001 Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
ASTM F 2315 : 2010 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
ASTM F 2149 : 2016 : REDLINE Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
ASTM F 2998 : 2014 Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells (Withdrawn 2023)
ASTM F 2315 : 2011 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
ASTM F 2149 : 2001 : R2007 Standard Test Method for Automated Analyses of Cells-the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F 2149 : 2016 Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
ASTM F 2315 : 2003 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
ASTM F 2315 : 2018 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

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