Standards
Overview of Regulatory Standards and Guidance on Hemodynamic Measurements
| Type | Organisation | Nr. | Title | Version | Summary |
|---|---|---|---|---|---|
| Standard | IEC | 80601-2-30 | Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers | 2018 | EC 80601-2-30:2018 specifies the basic safety and essential performance requirements for automated sphygmomanometers and their accessories, focusing on the non-continuous, indirect measurement of blood pressure using an inflatable cuff. The second edition updates the 2009 standard with technical revisions, aligning with other IEC standards, adding requirements for public self-use devices, and ensuring compatibility with ISO 80369 connectors. |
| Standard | IEC | 60601-2-33 | Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 2022 | The scope of this document covers the basic safety and essential performance of Magnetic Resonance (MR) equipment and systems, applying to both unless specified otherwise, and excluding use beyond their intended purpose or in interventional MR examinations. Its objective is to establish requirements that ensure protection of both patients and MR workers. |
| Standard | IEC | 60601-2-34 | Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment | 2024 | This standard specifies the basic safety and essential performance requirements for invasive blood pressure monitoring equipment used in professional healthcare facilities and emergency medical service environments, excluding components such as catheter tubing, needles, and non-invasive monitoring equipment. It clarifies that requirements apply primarily to the equipment itself, and only to systems when safety functions are implemented at the system level. |
| Standard | IEC | 60601-2-44 | Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography | 2009 | This standard applies to the basic safety and essential performance of CT scanners, defined as medical electrical equipment with enclosed X-ray sources and detectors in a toroidal structure, and includes safety requirements for associated X-ray generators. Its objective is to establish safety and performance requirements, along with compliance methods, addressing aspects such as reproducibility, accuracy, and radiation protection in line with ICRP principles of justification, optimization, and dose management |
| Standard | IEC | 80601-2-49 | Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors | 2018 | IEC 80601-2-49:2018 defines safety and essential performance requirements for multifunction patient monitors used in healthcare facilities, emergency services, or home care, when monitoring a single patient with two or more physiological units. It excludes requirements for individual monitoring modules (e.g., ECG, invasive pressure, SpO₂), implantable parts, and replaces the 2011 edition by aligning with updated IEC 60601-1 and related collateral standards. |
| Standard | ANSI/AAMI | BP22 | Blood Pressure Transducers | 1994 (R2016) | This standard provides performance and safety requirements for transducers, including cables, designed for blood pressure measurements through an indwelling catheter or direct puncture, and also provides disclosure requirements to permit the user to determine the compatibility between the transducer and blood pressure monitor. This standard is a combined revision of two American National Standards (ANSI/AAMI BP22-1986 and ANSI/AAMI BP23-1986. |
| Standard | ISO | 81060-1 | Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type | 2007-12 | ISO 81060-1:2007 defines safety, performance, and labeling requirements for non-automated sphygmomanometers and their accessories, which use inflatable cuffs for non-invasive blood pressure measurement by operator observation. It also specifies test methods to verify accuracy for devices with pressure-sensing elements and displays used alongside blood flow detection. |
| Standard | ISO | 81060-2 | Part 2: Clinical investigation of intermittent automated measurement type | 2018 | This document sets requirements and methods for clinical investigations of sphygmomanometers used for intermittent, non-invasive, automated blood pressure estimation with a cuff. It applies to devices for all patient populations and use conditions, specifies disclosure requirements for devices that pass clinical investigation, and excludes non-automated sphygmomanometers, invasive monitors, and cuff sets of differing materials or construction. |
| Standard | ISO/TS | 81060-5 | Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers | 2020 | This document defines requirements for the repeatability and reproducibility of non-invasive blood pressure (NIBP) simulators used to test automated oscillometric sphygmomanometers, including verification of pulse rate settings. It does not address accuracy against human measurements, cuff properties, or simulator-sphygmomanometer interaction, which are evaluated separately in clinical investigations. |
| Standard | IEEE | 1708 | IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices | 2014 | IEEE Std 1708 defines wearable cuffless blood pressure devices and sets objective methods for their performance evaluation, regardless of form, attachment, or measurement mode (e.g., short-term, continuous, or beat-to-beat). It addresses the lack of existing standards for cuffless devices, providing guidance for manufacturers, purchasers, and healthcare professionals to ensure proper qualification, validation, and informed use of these emerging technologies. |
| Standard | ISO/IEEE | 11073-20601 | Part 20601: Personal health device communication — Application profile — Optimized exchange protocol | 2022 | This ISO/IEEE 11073 standard defines an optimized exchange protocol and modeling techniques to ensure interoperability between different types and vendors of personal health devices. It provides a common abstract data framework with transport-independent syntax, enabling logical connections, communication services, and presentation capabilities tailored to personal health applications. |
| Standard | ISO | 81060-3 | Part 3: Clinical investigation of continuous automated measurement type | 2022 | This document defines the requirements and methods for clinical investigations of continuous automated non-invasive sphygmomanometers, addressing both trending and absolute accuracy devices across all patient populations and use conditions. It excludes usability aspects, representation of output, and devices such as non-automated, intermittent automated, or invasive monitors, while specifying additional disclosure requirements for devices that undergo clinical investigation. |
| Standard | ISO | 10555-1 | Intravascular catheters — Sterile and single-use catheters Part 1: General requirements | 2023 | This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application. |
| Standard | ISO | 10555-3 | Intravascular catheters — Sterile and single-use catheters Part 3: Central venous catheters | 2013 | ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use. |
| Standard | IEC | 60601-2-25 | Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | 2011 | IEC 60601-2-25:2011 specifies requirements for the basic safety and essential performance of diagnostic electrocardiographs, including those used in ambulances and air transport, while excluding vectorcardiographs, ambulatory ECG equipment, and cardiac monitors not intended for diagnostic ECG reports. This second edition constitutes a technical revision that merges and replaces IEC 60601-2-25:1993 and IEC 60601-2-51:2003, aligning with the third edition of the general standard and introducing both reformatting and technical changes. |
| Standard | IEC | 60601-2-37 | Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | 2024 | IEC 60601-2-37:2024 specifies requirements for the basic safety and essential performance of ultrasonic diagnostic equipment and systems, excluding therapeutic devices, and replaces the 2007 edition with its 2015 amendment. The revision introduces updates aligned with the amended general IEC 60601-1 standard, updated normative references, developments in ultrasonics standards, and a full revision of Clause 201.11 on protection against excessive temperatures and other hazards. |
| Guidelines | ESC | doi:10.1093/eurheartj/ehz405 | 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS): The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC) Free | 2019 | The 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism, developed in collaboration with the European Respiratory Society, provide updated recommendations on risk stratification, diagnostic strategies, and treatment approaches, including the preferential use of non-vitamin K antagonist oral anticoagulants (NOACs). They also introduce revised definitions of haemodynamic instability, propose dedicated management algorithms for high-risk and pregnancy-associated PE, and emphasize structured long-term follow-up and prevention of recurrence. |
| Guidelines | ESC | https://doi.org/10.1093/eurheartj/ehab368 | 021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC | 2021 | The 2021 ESC Guidelines on heart failure provide updated, evidence-based recommendations for the diagnosis and management of heart failure across all phenotypes (HFrEF, HFmrEF, HFpEF), with new treatment algorithms and expanded guidance on comorbidities, device therapy, and patient follow-up. Key updates include the introduction of SGLT2 inhibitors as a core therapy, a reclassification of HF with mildly reduced ejection fraction, new quality indicators, and refined recommendations for advanced heart failure management, comorbidity care, and prevention strategies. |
| Guidelines | ESC/ERS | doi.org/10.1093/eurheartj/ehac237 | 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: Developed by the task force for the diagnosis and treatment of pulmonary hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Endorsed by the International Society for Heart and Lung Transplantation (ISHLT) and the European Reference Network on rare respiratory diseases (ERN-LUNG). | 2022 | The 2022 ESC/ERS Guidelines provide updated definitions, diagnostic algorithms, risk stratification models, and treatment strategies for pulmonary hypertension (PH), with specific emphasis on pulmonary arterial hypertension (PAH) and chronic thrombo-embolic pulmonary hypertension (CTEPH). They integrate new evidence on hemodynamic thresholds, risk assessment, pharmacologic and interventional therapies, and establish standards for PH centres, aiming to improve early detection and individualized management across all PH subgroups. |
| Guidelines | ESC | doi.org/10.1093/eurheartj/ehad195 | 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC | 2023 | The 2023 Focused Update of the 2021 ESC Guidelines for acute and chronic heart failure incorporates new evidence from recent randomized controlled trials, leading to updated recommendations for the management of HF with mildly reduced ejection fraction (HFmrEF), HF with preserved ejection fraction (HFpEF), acute HF, and key comorbidities such as diabetes, chronic kidney disease, and iron deficiency. These updates emphasize SGLT2 inhibitors, finerenone, intravenous iron therapy, and optimized post-discharge care, while refining diagnostic and therapeutic strategies to improve patient outcomes. |
| Guidelines | ESC | doi.org/10.1093/eurheartj/ehad191 | 2023 ESC Guidelines for the management of acute coronary syndromes: Developed by the task force on the management of acute coronary syndromes of the European Society of Cardiology (ESC) | 2023 | The 2023 ESC Guidelines for the management of acute coronary syndromes (ACS) provide updated, evidence-based recommendations on the diagnosis, triage, and treatment of ACS, covering both STEMI and NSTE-ACS. Key guidance includes the use of high-sensitivity troponin algorithms, early invasive or reperfusion strategies, optimized antithrombotic therapy, revascularization approaches, and long-term secondary prevention, with a strong emphasis on patient-centered and risk-adapted care. |
| Guidelines | ESC | doi.org/10.1093/eurheartj/ehae178 | 2024 ESC Guidelines for the management of elevated blood pressure and hypertension: Developed by the task force on the management of elevated blood pressure and hypertension of the European Society of Cardiology (ESC) and endorsed by the European Society of Endocrinology (ESE) and the European Stroke Organisation (ESO) | 2024 | The 2024 ESC Guidelines for the management of elevated blood pressure and hypertension update the 2018 version by introducing the category of “elevated blood pressure” (120–139/70–89 mmHg), emphasizing cardiovascular risk–based management, and recommending a target systolic BP of 120–129 mmHg for most patients if well tolerated. The guidelines place stronger focus on outcome-driven evidence, personalized treatment (especially in older or frail patients), and wider use of out-of-office blood pressure monitoring, while also integrating sex, gender, and patient-centered perspectives throughout. |
| Guidelines | ACC | https://doi.org/10.1016/j.jacc.2021.12.012 | 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines | 2022 | The 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure replaces the 2013 guideline and 2017 focused update, offering patient-centered, evidence-based recommendations for the prevention, diagnosis, and treatment of heart failure. It incorporates new clinical evidence, updates prior recommendations, introduces new guidance where supported by data, and includes value statements for therapies with strong economic analyses to improve quality of care and patient outcomes. |
| Guidelines | AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM | https://doi.org/10.1016/j.jacc.2025.05.007 | 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines | 2025 | The 2025 AHA/ACC multi-society Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults replaces the 2017 version, reflecting updated evidence for hypertension care. It is designed as a living document to guide primary care and specialty clinicians in applying current knowledge to improve prevention, diagnosis, and management of high blood pressure. |
| Guidelines | ACC | https://doi.org/10.1016/j.jacc.2025.02.018 | 2025 Concise Clinical Guidance: An ACC Expert Consensus Statement on the Evaluation and Management of Cardiogenic Shock: A Report of the American College of Cardiology Solution Set Oversight Committee | 2025 | Heart failure–related cardiogenic shock (HF-CS) has risen in incidence in the United States, differing significantly from AMI-related shock in patient characteristics, comorbidities, and outcomes, while randomized trials have yet to identify mortality-reducing strategies beyond early revascularization in AMI-CS; the DanGer Shock trial was the first to show survival benefit with early microaxial flow pump use in select STEMI-related shock patients. In response to persistent gaps, the ACC convened a multidisciplinary expert roundtable to develop Concise Clinical Guidance that offers actionable, evidence-informed recommendations for the evaluation and management of cardiogenic shock, grounded in shared decision-making and tailored to diverse clinical settings. |
| Guidelines | ESICM | DOI: 10.1007/s00134-025-08137-z | ESICM guidelines on circulatory shock and hemodynamic monitoring 2025 | 2025 | These ESICM guidelines formulate 50 evidence-based and good-practice recommendations on the diagnosis of shock and hemodynamic monitoring in adult critically ill patients, based on PICO questions and the GRADE approach. They emphasize bedside assessment of skin perfusion, serial venous oxygen and CO₂ gap measurements, dynamic over static indices to guide fluid responsiveness, advanced monitoring of CO/stroke volume and arterial pressure in non-responders, and echocardiography as first-line imaging to classify shock and characterize ventricular dysfunction. |
| Guidelines | PVRI | DOI: 10.1002/pul2.70240 | Knowledge Gaps and Controversies on Cardiopulmonary Exercise Testing in the Assessment of Pulmonary Vascular Disease: An Official Statement of the Pulmonary Vascular Research Institute Exercise and Right Ventricular Function Task Force | 2026 | Exercise testing has long been essential for evaluating diagnosis, prognosis, and functional status in pulmonary hypertension (PH). Recent advances have clarified its role in defining reference values and prognostic markers. Nonetheless, substantial knowledge gaps persist regarding the implementation of invasive cardiopulmonary exercise testing (iCPET) and its potential to inform pathophysiology and therapeutic decision-making. This statement addresses the knowledge gaps that hinder the application of iCPET and exercise right heart catheterization (RHC) in the assessment of PH. We present research priorities and scenarios in which these tests may clarify drug mechanisms and support PH subphenotyping. An international, multidisciplinary task force of cardiology and pulmonology experts reviewed the literature and formulated consensus recommendations through iterative discussions. |
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