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British Standards for 11.100.20 Biological evaluation of medical devices | Module: ICS 11.100.20

Standards Shop | ICS 11 | ICS 11.100 |  ICS 11.100.20

BS EN ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
SKU/ISBN:9780580541896

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DD ISO/TS 10993-20:2006
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
SKU/ISBN:0580492281

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BS EN ISO 10993-13:2010
Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices
SKU/ISBN:9780580577192

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BS EN ISO 10993-5:2009
Biological evaluation of medical devices Tests for in vitro cytotoxicity
SKU/ISBN:9780580582592

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BS EN ISO 10993-14:2009
Biological evaluation of medical devices Identification and quantification of degradation products from ceramics
SKU/ISBN:9780580658259

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PD ISO/TR 22442-4:2010
Medical devices utilizing animal tissues and their derivatives Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
SKU/ISBN:9780580716669

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BS EN ISO 10993-6:2016
Biological evaluation of medical devices Tests for local effects after implantation
SKU/ISBN:9780580786853

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PD ISO/TS 16782:2016
Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
SKU/ISBN:9780580955464

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PD ISO/TR 15499:2016
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
SKU/ISBN:9780580959837

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BS EN ISO 10993-4:2017
Biological evaluation of medical devices Selection of tests for interactions with blood
SKU/ISBN:9780580844577

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PD ISO/TS 21726:2019
Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
SKU/ISBN:9780580997389

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PD ISO/TR 10993-33:2015
Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
SKU/ISBN:9780580847813

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BS EN ISO 10993-3:2014
Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity
SKU/ISBN:9780580696916

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PD ISO/TR 10993-22:2017
Biological evaluation of medical devices Guidance on nanomaterials
SKU/ISBN:9.78058E+12

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PD ISO/TS 10993-19:2020
Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
SKU/ISBN:9780580997556

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BS EN ISO 10993-16:2017
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
SKU/ISBN:9780539134605

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BS EN ISO 20776-1:2020
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobi..
SKU/ISBN:9780580523823

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BS EN ISO 14155:2020
Clinical investigation of medical devices for human subjects. Good clinical practice
SKU/ISBN:9780539162202

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BS EN ISO 10993-1:2020
Biological evaluation of medical devices Evaluation and testing within a risk management process
SKU/ISBN:9780580948688

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BS EN ISO 10993-23:2021
Biological evaluation of medical devices Tests for irritation
SKU/ISBN:9780580997433

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BS EN ISO 10993-12:2021
Biological evaluation of medical devices Sample preparation and reference materials
SKU/ISBN:9780539007510

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PD ISO/TR 21582:2021
Pyrogenicity. Principles and methods for pyrogen testing of medical devices
SKU/ISBN:9.78058E+12

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BS EN ISO 20776-2:2021
Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Evaluation of performance of antimicrobial susceptibility te..
SKU/ISBN:9780539151121

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BS EN ISO 10993-7:2008+A1:2022
Biological evaluation of medical devices Ethylene oxide sterilization residuals
SKU/ISBN:9780580971808

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BS EN ISO 10993-11:2018
Biological evaluation of medical devices Tests for systemic toxicity
SKU/ISBN:9780539208535

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BS ISO 17593:2022
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
SKU/ISBN:9780539064469

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BS EN ISO 10993-9:2021
Biological evaluation of medical devices Framework for identification and quantification of potential degradation products
SKU/ISBN:9780580970788

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BS EN ISO 10993-2:2022
Biological evaluation of medical devices Animal welfare requirements
SKU/ISBN:9780539251739

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BS EN ISO 10993-10:2023
Biological evaluation of medical devices Tests for skin sensitization
SKU/ISBN:9780539010480

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PD ISO/TR 10993-55:2023
Biological evaluation of medical devices Interlaboratory study on cytotoxicity
SKU/ISBN:9780539233438

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BS EN ISO 10993-15:2023
Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys
SKU/ISBN:9780580971082

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BS EN ISO 10993-18:2020+A1:2023
Biological evaluation of medical devices Chemical characterization of medical device materials within a risk management process
SKU/ISBN:9780539181326

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PD ISO/TS 11796:2023
Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
SKU/ISBN:9780539233520

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BS EN ISO 10993-17:2023
Biological evaluation of medical devices Toxicological risk assessment of medical device constituents
SKU/ISBN:9780539013320

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Standards Shop | ICS 11 | ICS 11.100 |  ICS 11.100.20

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