Health Care and Medical Devices

Origin: CSA
Close date: Apr 14, 2020
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This Standard provides a Framework for the Paramedic Service Organization’s (PSO) response to the opioid crisis. The Framework provides practical guidance on how to address opioid use in the out-of-hospital setting, including caring for patients during a poisoning or overdose, as well as tracking the crisis across paramedic service organizations.

Origin: CSA
Close date: Apr 14, 2020
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Cette norme fournit un cadre pour la réponse de l’organisation de services paramédicaux (OSP) à la crise des opioïdes. Le cadre fournit des conseils pratiques sur la manière de à adresser la consommation d’opioïdes en milieu extrahospitalier, notamment pour les soins prodigués aux patients intoxiqués ou faisant l’objet d’une surdose, ainsi que sur le suivi de la crise dans les organisations de services paramédicaux.

Origin: IEC
Close date: May 1, 2020
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Scope:

This part of IEC 60601 applies to the basic safety of hearing aids and hearing aid systems, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.

If a clause or subclause is specifically intended to be applicable to hearing aids only, or to hearing aid systems only, the title and content of that clause or subclause will say so. if that is not the case, the clause or subclause applies both to hearing aids and to hearing aid systems, as relevant.

Hazards inherent in the intended physiological function of hearing aids or hearing aid systems within the scope of this document are not covered by specific requirements in this document except in 201.7.9.2 and 201.9.6.

NOTE See also 4.2 of the general standard.

Accessories to hearing aids in the home healthcare environment (e.g. remote control units, audio streamers, battery chargers, power supplies) can be tested according to the applicable standard, IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied. Hearing aids do not have a mains part intended for connection to ac supply mains. The connection to the supply mains of a hearing aid system is covered by power supply, charger or other types of accessories.

Accessories with functional connection to a hearing aid may form a hearing aid system. Hearing aid related accessories that are not physically connected to the hearing aid during normal use are not considered to be applied part, because they do not directly contribute to the intended use of the hearing aid.

Wireless programming interfaces are covered by the applicable standard IEC 60065, IEC 60950-1, IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied.

Programming interfaces with wired connection to the hearing aid are covered by the general standard.

NOTE Detachable parts of hearing aids, even if supplied separately (e.g. ear hooks, domes, wax guards etc.), are not considered as accessories, but as component parts.

This document does not apply to:

• Cochlear implants or other implanted hearing aids;
• Bone conduction hearing aids;
• Educational hearing aids (i.e. group hearing aids, auditory trainers etc.);
• The application of a hearing aid for the measurement of hearing levels; IEC 60645-1 applies; – fix installed audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1;
• The sound generating function of a tinnitus masker.

This document does not address applicable testing for intentional RF radiation of wireless equipment (e.g. maximum radiated output power, modulation bandwidth, etc.).

Origin: IEC
Close date: May 1, 2020
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Scope:

This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.

These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.

The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.

This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.

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 clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 7.2.13 and 8.4.1 of the general standard.

NOTE 1 See also 4.2 of the general standard. “The general standard” is IEC 60601‐1:2005+AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

This document can also be applied to ME EQUIPMENT and their accessories used for compensation or alleviation of disease, injury or disability.

This document is not applicable to pulse oximeter equipment intended solely for foetal use.

This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.

NOTE 2 ME EQUIPMENT that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.

This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use.

This document is a particular standard in the IEC 60601‐1 and ISO/IEC 80601 series of standards.

Origin: IEC
Close date: May 1, 2020
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Scope:

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 sets laboratory characterization test limits for the screening thermograph.

NOTE 101 A screening thermograph is intended for screening of a human subject and detection of skin temperature elevated above normal. An elevated skin temperature needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see ISO 80601-2-56 [30]).

NOTE 102 The main part of such equipment is commonly referred to as an infrared camera.

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 clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

Origin: IEC
Close date: May 1, 2020
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Scope

201.1 Scope and object

IEC 60601-1:2005, Clause 1 applies, except as follows:

201.1.1 * Scope

Replacement:

This International Standard specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT.

This International Standard specifies requirements for

- anaesthetic gas monitoring
- carbon dioxide monitoring, and
- oxygen monitoring.

NOTE 1 An RGM can be either standalone ME EQUIPMENT or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.

This International Standard is not applicable to an RGM intended for use with flammable anaesthetic agents.

Environmental aspects are addressed in Annex BB.

NOTE 2 Additional aspects of environmental impact are addressed in ISO 14971 and IEC 60601-1-9.

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 clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this particular standard, except in 7.2.13 and 8.4.1 of the general standard (IEC 60601-1).

NOTE 3 See also 4.2 of the general standard.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an RGM (as defined in 201.3.210) and its ACCESSORIES.

NOTE ACCESSORIES are included because the combination of the RGM and the ACCESSORIES needs to be safe. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of an RGM.

Origin:
Close date: May 20, 2020
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adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 20914

Origin: ISO
Close date: May 26, 2020
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1 Scope

[Replace the first paragraph with the following]

This Standard specifies requirements for sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g., scalpel blades, trocars, hypodermic needles, and syringes.

[Replace the third and fourth paragraphs with the following two paragraphs]

This document includes: design and functionality requirements, and performance testing for single-use and reusable sharps containers; and lifespan simulation, cleaning and decontamination, microbiological validation, and quality monitoring for reusable sharps containers.

This Standard is not applicable to outer containers used in the transportation of filled single-use sharps containers.