11.100.20 : Biological evaluation of medical devices

ASTM E3060-16

ASTM E3060-16

Superseded Historical

Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

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ASTM E3152-18

ASTM E3152-18

Superseded Historical

Standard Guide for Standard Test Methods and Practices Available for Determining Antifungal Activity on Natural or Synthetic Substrates Treated with Antimicrobial Agents

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ASTM E2805-18

ASTM E2805-18

Superseded Historical

Standard Practice for Measurement of the Biological Activity of Ricin

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PD ISO/TR 10993-33:2015

PD ISO/TR 10993-33:2015

Active Most Recent

Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement ISO 10993-3

€374.00

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PD ISO/TR 10993-22:2017

PD ISO/TR 10993-22:2017

Active Most Recent

Biological evaluation of medical devices Guidance on nanomaterials

€404.00

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PD ISO/TR 21582:2021

PD ISO/TR 21582:2021

Active Most Recent

Pyrogenicity. Principles and methods for pyrogen testing of medical devices

€269.00

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PD ISO/TS 16782:2016

PD ISO/TS 16782:2016

Active Most Recent

Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

€269.00

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BS EN ISO 20776-1:2020

BS EN ISO 20776-1:2020

Active Most Recent

Susceptibility testing of infectious agents and evaluation performance antimicrobial susceptibility test devices Broth micro-dilution reference method for the in vitro activity against rapidly growing aerobic bacteria involved diseases

€269.00

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PD ISO/TS 21726:2019

PD ISO/TS 21726:2019

Active Most Recent

Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

€193.00

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PD ISO/TS 10993-19:2020

PD ISO/TS 10993-19:2020

Active Most Recent

Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization materials

€269.00

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BS EN ISO 10993-18:2009

BS EN ISO 10993-18:2009

Superseded Historical

Biological evaluation of medical devices Chemical characterization materials

€269.00

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BS EN ISO 10993-14:2009

BS EN ISO 10993-14:2009

Active Most Recent

Biological evaluation of medical devices Identification and quantification degradation products from ceramics

€193.00

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BS EN ISO 18812:2003

BS EN ISO 18812:2003

Active Most Recent

Health informatics. Clinical analyser interfaces to laboratory information systems. Use profiles

€374.00

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DD ISO/TS 10993-19:2006

DD ISO/TS 10993-19:2006

Withdrawn Most Recent

Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization materials

€269.00

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BS EN ISO 10993-2:2006

BS EN ISO 10993-2:2006

Superseded Historical

Biological evaluation of medical devices Animal welfare requirements

€269.00

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