11.100 : Laboratory medicine

11.100.01

Laboratory medicine in general

11.100.10

In vitro diagnostic test systems

11.100.20

Biological evaluation of medical devices

11.100.30

Analysis of blood and urine

11.100.99

Other standards related to laboratory medicine
BS EN ISO 18113-4:2011

BS EN ISO 18113-4:2011

Superseded Historical

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) reagents for self-testing

€269.00

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BS EN ISO 18113-5:2011

BS EN ISO 18113-5:2011

Superseded Historical

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) instruments for self-testing

€193.00

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PD ISO/TS 17518:2015

PD ISO/TS 17518:2015

Active Most Recent

Medical laboratories. Reagents for staining biological material. Guidance for users

€269.00

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PD ISO/TS 20658:2017

PD ISO/TS 20658:2017

Active Most Recent

Medical laboratories. Requirements for collection, transport, receipt, and handling of samples

€355.00

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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 ISO 21474-1:2020

BS ISO 21474-1:2020

Active Most Recent

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Terminology and general requirements acid quality evaluation

€269.00

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PD ISO/TS 17822-1:2014

PD ISO/TS 17822-1:2014

Active Most Recent

In vitro diagnostic test systems. Qualitative nucleic acid-based in examination procedures for detection and identification of microbial pathogens General requirements, terms definitions

€316.00

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PD CEN/TS 16826-3:2018

PD CEN/TS 16826-3:2018

Superseded Historical

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes snap frozen tissue Isolated DNA

€193.00

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BS EN IEC 61010-2-011:2021+A11:2021

BS EN IEC 61010-2-011:2021+A11:2021

Active Most Recent

Safety requirements for electrical equipment measurement, control, and laboratory use Particular refrigerating

€374.00

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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 IEC 61326-2-6:2021

BS EN IEC 61326-2-6:2021

Active Most Recent

Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical

€193.00

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