ASTM E1262 Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
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- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
- ASTM F2721 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
- ASTM F2451 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
- ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
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- ASTM F2721 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
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- ASTM F2131 Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line
- ASTM F2529 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
- ASTM F2721 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
- ASTM F2451 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
- ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
- ASTM F2451 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
- ASTM F2721 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
- ASTM F2529 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
- ASTM F2131 Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line
- ASTM F2131 Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line
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- ASTM F2451 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
- ASTM F2721 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
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- ASTM F2721 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
- ASTM F2451 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
- ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
- ASTM F2451 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
- ASTM F2721 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
- ASTM F2721 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
- ASTM F2451 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
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ASTM International
Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
N E1262
Annotation
This guide highlights some of the more relevant biological concepts as they are currently understood, and summarizes the critical technical aspects for acceptable bioassay performances as they currently are perceived and practiced. The Chinese hamster ovary cell/hypoxanthine guanine phosphoribosyl transferase (CHO/HGPRT) assay (1)2 has been widely applied to the toxicological evaluation of industrial and environmental chemicals.
This guide concentrates on the practical aspects of cell culture, mutagenesis procedures, data analysis, quality control, and testing strategy. The suggested approach represents a consensus of the panel members for the performance of the assay. It is to be understood, however, that these are merely general guidelines and are not to be followed without the use of sound scientific judgement. Users of the assay should evaluate their approach based on the properties of the substances to be tested and the questions to be answered.
Deviation from the guidelines based on sound scientific judgement should by no means invalidate the results obtained.
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
This 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.
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