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Standards [CURRENT]

ISO 10079-2

Medical suction equipment - Part 2: Manually powered suction equipment
Edition 2022-03

Pre-standard

ISO/TS 22077-4

Health informatics - Medical waveform format - Part 4: Stress test electrocardiography
Edition 2019-10

Pre-standard

ISO/TS 22077-5

Health informatics - Medical waveform format - Part 5: Neurophysiological signals
Edition 2021-04

Pre-standard

ISO/TS 23541-1

Health informatics - Categorial structure for representation of 3D human body position system - Part 1: Bones
Edition 2021-05

Pre-standard

ISO/TS 14441

Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment
Edition 2013-12

Pre-standard [New]

ISO/TS 20428

Genomics Informatics - Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records
Edition 2024-06

Pre-standard

ISO/TS 11137-4

Sterilization of health care products - Radiation - Part 4: Guidance on process control
Edition 2020-06

Pre-standard

ISO/TS 4425

Genomics informatics - Data elements and their metadata for describing the microsatellite instability (MSI) information of clinical massive parallel DNA sequencing
Edition 2023-04

Technical rule [CURRENT]

IEC/TR 80001-2-9

Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
Edition 2017-01

Pre-standard

ISO/TS 22456

Sterilization of healthcare products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Edition 2021-03

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