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ISO 4307:2021PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNAISO/TS 5441:2024PublishedCompetence requirements for biorisk management advisorsISO 5649:2024PublishedMedical laboratories — Concepts and specifications for the design, development, implementation and use of laboratory-developed testsISO/TS 5798:2022PublishedIn vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methodsISO 6717:2021PublishedIn vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than bloodISO 7405:2025PublishedDentistry — Evaluation of biocompatibility of medical devices used in dentistryISO/TS 7446:2026PublishedImplementation guidance for biorisk management for laboratories and other related organizationsISO/TS 7552-2:2024PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 2: Isolated DNAISO/TS 7552-3:2024PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 3: Preparations for analytical CTC stainingISO/TS 7552-1:2024PublishedMolecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 1: Isolated RNAISO 7713:1985PublishedLaboratory glassware — Disposable serological pipettesISO 10993-6:2026PublishedBiological evaluation of medical devices — Part 6: Tests for local effects after implantationISO 10993-7:2026PublishedBiological evaluation of medical devices — Part 7: Ethylene oxide sterilization residualsISO 10993-3:2026PublishedBiological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicityISO 10993-1:2025PublishedBiological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management processISO/TR 10993-55:2023PublishedBiological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicityISO 10993-17:2023PublishedBiological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituentsISO 10993-2:2022PublishedBiological evaluation of medical devices — Part 2: Animal welfare requirementsISO 10993-23:2021PublishedBiological evaluation of medical devices — Part 23: Tests for irritationISO 10993-10:2021PublishedBiological evaluation of medical devices — Part 10: Tests for skin sensitizationISO 10993-12:2021PublishedBiological evaluation of medical devices — Part 12: Sample preparation and reference materialsISO 10993-18:2020PublishedBiological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management processISO/TS 10993-19:2020PublishedBiological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materialsISO 10993-15:2019PublishedBiological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloysISO 10993-9:2019PublishedBiological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products