Safety and
Performance Standards

IEC 60601-1 Series Medical Electrical Equipment

This International standard relates to electrical safety, RFI/EMC, and other safety aspects of electrical products. Not all Vitalograph products are required to meet this standard, but for those that are, Vitalograph Products have been certified to conform to the appropriate parts since their inception in the late 1970s, assuring safety in line with the essential requirements.

ISO 26782 Spirometers

This performance and safety standard specifies requirements for spirometers intended for the assessment of pulmonary function in humans. This includes the measurement timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device. It applies to all spirometers regardless of the measurement method: flow-sensing, volume displacement and any other methods. This standard applies to all Vitalograph spirometers.

ISO 23747 Peak Flow Meters

This performance and safety standard addresses the discrepancy in readings obtained from peak flow meters and spirometers, together with issues caused by the peak flow meters with the Wright’s scale, which is non-linear. The standard requires testing for accuracy, reproducibility and frequency response. A meter with poor frequency response will result in errors leading to potential issues diagnosing and monitoring lung conditions. The standard also requires the meters to be checked for accuracy on a routine basis, as recommended by the manufacturer.

IEC EN 60601-2-27 ECG Devices and Software

This performance and safety standard relates to medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. Vitalograph provides ECG devices and software in conformance to this standard.

NIOSH CWHSP

The National Institute for Occupational Safety and Health (NIOSH) operates the Coal Workers’ Health Surveillance Program (CWHSP) which provides respiratory health screening and surveillance to US coal miners. Under this program, coal miners are entitled to respiratory health screening via questionnaires, chest radiography, and spirometry upon entry into the coal mining workforce and then periodically throughout their careers.
NIOSH approved CWHSP medical facilities providing respiratory health screening for miners must use spirometers that meet specific NIOSH requirements regarding the output data and content of spirometry test reports. Vitalograph Pneumotrac Spirotrac and Vitalograph COMPACT Workstation have the report and electronic data transfer file approved.

FDA 21CFR Part 11

FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect the public health.

EN ISO 14971 Medical Devices – Application of Risk Management to Medical Devices

Specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.

EN ISO 10993-1 Biological Evaluation of Medical Devices, Part 1. Evaluation and Testing

Applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

ATS/ERS 2019

Standards and consensus recommendations presented for manufacturers, clinicians, operators, and researchers with the aims of increasing the accuracy, precision, and quality of spirometric measurements and improving the patient experience.

IEC60601-2-25

Medical electrical equipment – Particular requirements for the basic safety and essential performance of electrocardiographs.

IEC60601-2-47

Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.

EN 60601-1-11

Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

ICH E14 (R3)

This guideline concerns the clinical evaluation of QT/QTc interval prolongation and proarrhytmic potential for non-antiarrhythmic medicinal products. It addresses the electrocardiograms methodology, gender, positive control, study design, use of concentration response modeling of QTc data and electrocardiogram monitoring in late stage clinical trials.