Case Medical Equipment Standards

This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME EQUIPMENT. This document...

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this International Standard....

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that...

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the ENCLOSED LASER...

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the ENCLOSED LASER...

5.1 Most heated apparatus in industrial, commercial, and residential service are insulated, unless thermal insulation interferes with their function; for example, it is inappropriate to insulate the bottom surface of a flatiron. However, surface temperatures of insulated equipment and...

This standard specifies U.S. consensus standard methods and instrumentation and test facilities requirements for measurement of radio frequency (RF) signals and noise emitted from unlicensed wireless devices (also called unlicensed transmitters, intentional radiators, and license-exempt...

This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and...

This document applies to the BASIC SAFETY and ESSENT IA L PERFORMANC E of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPME NT intended: -- for those P AT IENTS who can be dependent on artificial ventilation; -- for use in an environment, which provides...

1.1 This standard provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies. 1.1.1 Some of the techniques discussed in this guide may be applicable to...

This part of IEC 61810 applies to electromechanical elementary relays (non-specified time allor- nothing relays) for incorporation into low voltage equipment (circuits up to 1 000 V alternate current or 1 500 V direct current). It defines the basic functional and safety requirements and...

This document specifies the requirements for valve protection caps, valve guards and shrouds used on cylinders for liquefied, dissolved or compressed gases. Valve protection caps, valve guards or shrouds are some of the options available to protect cylinder valves (including Valves with Integral...

This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for non-continuous indirect estimation of the BLOOD PRESSURE without...

4.1 Reusable medical devices have a range of cleanability. The equipment, effort, and time expended for cleaning devices should be feasible in the intended setting. For that reason, it is essential that cleanability be considered during the design phase. 4.2 The next section...

This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT'S MOVEMENT...

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its...

This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in...

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories: - intended for use in...

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories: - intended for use in...

This Standard covers the protection from lightning of a) recreational, residential, institutional, medical, agricultural, industrial, commercial, military, and telecommunications buildings and structures; b) tall, slender structures such as smokestacks, silos, tanks, towers, masts, and...