Electrical

Categories: Electrical
Origin: CSA
Close date: Jan 21, 2023
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IEC 60601-1:2005+Amendment 1:2012, Clause 1 applies, except as follows:

201.1.1 Scope

IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by:

This particular standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended to increase the oxygen concentration of gas intended to be delivered to a single PATIENT. Such OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including TRANSIT-OPERABLE use by a single PATIENT in various environments including any private and public transportation as well as in commercial aircraft.

NOTE 1 Such an OXYGEN CONCENTRATOR can also be used in professional healthcare facilities.

This particular standard is applicable to a TRANSIT-OPERABLE and non-TRANSIT-OPERABLE OXYGEN CONCENTRATOR. This particular standard is applicable to an OXYGEN CONCENTRATOR integrated into or used with other medical devices, ME EQUIPMENT or ME SYSTEMS.

EXAMPLE 1 An OXYGEN CONCENTRATOR with integrated oxygen CONSERVING EQUIPMENT or humidifier.

EXAMPLE 2 An OXYGEN CONCENTRATOR used with a flowmeter stand.

EXAMPLE 3 An OXYGEN CONCENTRATOR as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases.

EXAMPLE 4 An OXYGEN CONCENTRATOR with an integrated liquid reservoir or gas cylinder filling system.

This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to an OXYGEN CONCENTRATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the OXYGEN CONCENTRATOR.

This particular standard does not specify the requirements for OXYGEN CONCENTRATORS for use with a MEDICAL GAS PIPELINE SYSTEM which are given in ISO 10083.

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 standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE 2 See also 4.2 of the General Standard.

This International Standard is a particular standard in the IEC 60601-1 series of standards.

201.1.2 Object

IEC 60601-1:2005, 1.2 is replaced by:

The object of this International Standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an OXYGEN CONCENTRATOR [as defined in 201.3.203] and its ACCESSORIES.

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

Categories: Electrical
Origin: CSA
Close date: Jan 21, 2023
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Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME 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 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 standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

This particular standard specifies the safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

This particular standard does not apply to:

- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information see IEC 80601-2-35;
- INFANT INCUBATORS; for information see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information see IEC 60601-2-20;
- INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50.

SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. 

Categories: Electrical
Origin: CSA
Close date: Jan 21, 2023
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201.1 Scope, object and related standards 

Clause 1 of the general standard1 applies, except as follows: 

201.1.1 Scope 

Replacement: 

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 is of CLASS 3B or 4, or CLASS 3B, or CLASS 4. 

MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS which incorporate lasers as sources of energy being transferred to the PATIENT or animal and where the lasers are specified as above, are referred to as “laser equipment” in this document. 

NOTE 1 LASER PRODUCTS for these applications classified as a Class 1, Class 1M, CLASS 2, Class 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1:2014 and by the general standard. 

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 to ME EQUIPMENT and to ME SYSTEMS, as relevant. 

Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard. 

NOTE 2 See also 4.2, RISK MANAGEMENT process, of the general standard. 

NOTE 3 If the laser equipment is CLASS 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household, it is covered by IEC 60335-2-113:2016. 

Categories: Electrical
Origin: CSA
Close date: Jan 21, 2023
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Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT.

This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE.

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.

The standard does not formulate ESSENTIAL PERFORMANCE requirements related to INTERVENTIONAL MR EXAMINATIONS.

 

 

Categories: Electrical
Origin: CSA
Close date: Jan 21, 2023
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Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, also referred to as ME 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 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 standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

This particular standard does not apply to:

- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use, for information see IEC 80601-2-35;
- INFANT INCUBATORS; for information see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
- INFANT RADIANT WARMERS; for information see IEC 60601-2-21.

Categories: Electrical
Origin: CSA
Close date: Jan 21, 2023
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201.1 * Scope, object and related standards 
 
IEC 60601‐1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
 
NOTE The general standard is IEC 60601‐1:2005+AMD1:2012+AMD2:2020.

201.1.1 Scope 

IEC 60601‐1:2005+Amendment 1:2012, 1.1 is replaced by:
 
This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
 
* Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
 
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
 
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation.
 
This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea.
 
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
 
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
 
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 7.2.13 and 8.4.1 of the general standard.
 
NOTE See also 4.2 of the general standard.
 
This document is not applicable to high‐frequency jet ventilators (HFJVs) or high‐frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‐2‐87[13].

This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator‐dependent patients, which are given in ISO 80601‐2‐12.
 
This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‐2‐13[8].
 
This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator‐dependent patients, which are given in ISO 80601‐2‐72[9].

This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 80601‐2‐84[12].
 
This document does not specify the requirements for ventilators or accessories intended for home‐care ventilatory support, which are given in ISO 80601‐2‐79[10] and ISO 80601‐2‐80[11].
Categories: Electrical
Origin: CSA
Close date: Jan 21, 2023
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Scope, objective and related standards

Clause 1 of the general standard1) applies, except as follows:

Replacement:

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ECG ME EQUIPMENT and ACCESSORIES (including ECG ELECTRODES, TRUNK CABLES, and LEAD WIRES) as defined in 201.3.211, 201.3.240, and 201.3.222, hereinafter also referred to as ECG ME EQUIPMENT. Additional specific requirements apply to the ECG ME EQUIPMENT based on the INTENDED USE claimed by the MANUFACTURER for equipment intended for ECG PATIENT MONITORING, DIAGNOSTIC, or AMBULATORY use as defined in 201.3.226, 201.3.207 and 201.3.202 respectively. This particular standard applies to ECG ME EQUIPMENT for use in professional healthcare facilities as well as in EMERGENCY MEDICAL SERVICE ENVIRONMENTS and HOME HEALTHCARE ENVIRONMENTS.In addition, clauses may be applied to ACCESSORIES (including ECG ELECTRODES, TRUNK CABLES, and LEAD WIRES) or a part or parts of an ECG system (e.g AMBULATORY ECG RECORDER).

The scope for each of these types of ECG ME EQUIPMENT are described as follows:

ECG ME EQUIPMENT Any ECG device or system or part of a system that acquires an ECG signal from the body surface of one PATIENT and displays, records, analyzes, or transmits the resultant data for the purpose of diagnosing, treating, or monitoring that PATIENT. This includes any device or system or part of a system that meets the definition of MONITORING, DIAGNOSTIC, or AMBULATORY ECG ME EQUIPMENT as well as any other device that acquires and/or processes an ECG signal for the purpose of diagnosing, treating or monitoring a PATIENT based on the acquired body surface ECG signal. This does not include devices that are used for diagnosing, treating or monitoring PATIENTS based only on other types of cardiac signals such as magnetocardiographic signals or derived from other cardiac signals such as heart rate monitors derived from a photo plethysmograph or phonocardiograps. In addition, ECG ME EQUIPMENT does not include devices that are solely used for health and wellness (e.g. fitness trackers measuring heart rate solely to improve general wellness or athletic performance). However, devices that are part of consumer devices (such as a watch) that acquired an ECG and displays, records, analyzes, and/or transmits the ECG for the purpose of diagnosing, treating or monitoring the PATIENT are included in the scope of an ECG ME EQUIPMENT.This does not include external defibrillators unless they have an INTENDED USE for making a diagnosis, monitoring or treatment from the ECG waveform in addition to the function of delivering a defibrillation shock based on the ECG.

Any ECG ME EQUIPMENT that acquires a 12 LEAD2 ECG signal for the purpose of diagnosis from the interpretation of the cardiac rhythm, conduction, and waveform contour. This includes any device that acquires diagnostic resting ECG as well as any other type of ECG ME EQUIPMENT that claims to have the capability of acquiring a diagnostic 12 LEAD ECG. ECG ME EQUIPMENT that produces a diagnostic 12 LEAD ECG from non-standard electrode positionsis excluded from the scope of DIAGNOSTIC ECG ME EQUIPMENT. Devices which have multiple purposes and include the DIAGNOSTIC ECG ME EQUIPMENT definition in the INTENDED USE are included within this scope.

AMBULATORY ECG ME EQUIPMENT

Any ECG ME EQUIPMENT that acquires an ECG signal from an AMBULATORY PATIENT. Examples of AMBULATORY ECG ME EQUIPMENT include Holter systems and continuous long-term AMBULATORY full disclosure recording systems; Holter recorders, mobile cardiac telemetry and long-term AMBULATORY patch recorders, event recorders, and non-continuous loop recorders. Devices which have multiple purposes and include the AMBULATORY ECG ME EQUIPMENT definition in the INTENDED USE are included within this scope.