Health Care and Medical Devices

Contact: dean.taleb@csagroup.org
Origin: ISO
Close date: Mar 20, 2017
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201.1.
1 * Scope
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of oxygen CONSERVING EQUIPMENT, hereafter referred to as ME EQUIPMENT, in combination with its ACCESSORIES intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the PATIENT'S inspiratory cycle, when used in the HOME HEALTHCARE ENVIRONMENT. Oxygen CONSERVING EQUIPMENT is typically used by a LAY OPERATOR.
NOTE 1 CONSERVING EQUIPMENT can also be used in professional health care facilities.
NOTE 2 CONSERVING EQUIPMENT can be used with an oxygen concentrator.
This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to CONSERVING EQUIPMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the CONSERVING EQUIPMENT.
This particular standard is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
NOTE 3 CONSERVING EQUIPMENT complying with this particular standard can be incorporated with other devices that have their own standards, in which case the combination needs to comply with both standards.
EXAMPLES CONSERVING EQUIPMENT combined with a pressure regulator [2], an oxygen concentrator [1] or liquid oxygen equipment [6].
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 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 4 See also 4.2 of the general standard.
This particular standard is a particular standard in the IEC 60601 series of standards.

Contact: dean.taleb@csagroup.org
Origin: ISO
Close date: Mar 20, 2017
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201.1.
1 * Scope
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This particular standard 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.
This particular standard excludes SLEEP APNOEA BREATHING THERAPY EQUIPMENT intended for use with neonates.
This particular standard is applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are not dependent on mechanical ventilation.
This particular standard 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 particular standard 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. 3) Refer to Figure AA.1 for items covered further under this 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 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 4 See also 4.2 of the General Standard.

This particular standard is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs).[16]
This particular standard 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 particular standard does not specify the requirements for ventilators or ACCESSORIES intended for anaesthetic applications which are given in IEC 80601-2-13.
This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-24) .
This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for emergency and transport which are given in ISO 10651-35) .
This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for home-care ventilatory support devices which are given in ISO 10651-66) .
This particular standard is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

Contact: dean.taleb@csagroup.org
Origin: ISO
Close date: Mar 20, 2017
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201.1.1 Scope
Replacement:
This International standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM,
for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes,
hereinafter referred to as ME EQUIPMENT.
Not included within the scope of this particular standard are:
a) the part of ME EQUIPMENT, if provided, that measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules);
b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output;
c) pulse oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT
output. The requirements for pulse oximeter equipment are found in ISO 80601-2-61.
d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy, which may require different test procedures than defined herein.
e) FUNCTIONAL NEAR-INFRARED SPECTROSCOPY EQUIPMENT which measure changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin, which may require different test procedures than defined herein.

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Origin: CSA
Close date: Mar 20, 2017
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201.1.1 *Scope
IEC 60601‐1:2005+AMD1:2012, 1.1 is replaced by: This part of ISO 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in EQUIPMENT:
combination with its ACCESSORIES, hereafter referred to as MECARE ENVIRONMENT;
— intended for use in the HOME HEALTH
— intended for use by a LAY OPERATOR; ndr use withependepport.
— inteed fo PATIENTS who are dnt on mechanical ventilation for their life suENTILATORS can also be used foependent ort.
NOTE 1 Such Vr PATIENTS who are not dn ventilatory suppo HOME HEALT
NOTE 2 In theHCARE ENVIRONMENT, the power driving the VENTILATOR is often not reliable.
NOTE 3 Such VENTILATORS can also be used in non‐critical care applications of professional health care facilities. This part of ISO 80601 is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a VENTILATOR BREATHING SYSTEM or to a VENTILATOR where the characteristics of those S ca
ACCESSORIEn affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR. EXAMPLES Breathing tubes, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER,
external electrical power source, and DISTRIBUTED ALARM SYSTEM. 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 part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in 01
IEC 606‐1:2005+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601–1:2005+AMD1:2012, 4.2. This part of ISO 80601 is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT,
high‐frequency jet ventilators (HFJVs), and high‐frequency oscillatory ventilators (HFOVs)[35].
This part of ISO 80601 does not specify the requirements for cuirass and “iron‐lung” VENTILATORS. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for critical care applications, which are given in ISO 80601‐2‐12.

This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for
anaesthetic applications, which are given in ISO 80601‐2‐13. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for nc
emergey and transport which are given in ISO 10651‐3. NOTE 5 In the future, ISO 10651‐3 is expected to be harmonized with IEC 60601‐1:2005, at which time it will
be replaced by ISO 80601‐2‐xx. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for home‐care ventilatory support equipment (intended only to augment the ventilation of spontaneously g
breathinPATIENTS), which are given in ISO 10651‐6. NOTE 6 In the future, ISO 10651‐6 is expected to be harmonized with IEC 60601‐1:2005 and IEC 60601‐1‐
11:2015, at which time it will be replaced by ISO 80601‐2‐xx. This part of ISO 80601 does not specify the requirements for obstructive sleep apnoea therapy
ME EQUIPMENT, which are given in ISO 80601‐2‐70.[16] This part of ISO 80601 is a particular International Standard in the IEC 60601‐1 and ISO/IEC 80601 series of standards.
201.1.2 Object
IEC 60601‐1:2005+AMD1:2012, 1.2 is replaced by: The object of this part of ISO 80601 is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for a VENTILATOR, as defined in 201.3.217, and its ACCESSORIES. NOTE ACCESSORIES are included because the combination of the VENTILATOR and the ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of a VENTILATOR.