ČSN EN ISO 80601-2-72 (364801) Zrušená norma

Anotace obsahu normy

This part of ISO 80601 applies to the basic safety and essential performance of a ventilator in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT:
- intended for use in the HOME HEALTHCARE ENVIRONMENT;
- intended for use by a LAY OPERATOR;
- intended for use with PATIENTS who are dependent on mechanical ventilation for their life support.
NOTE 1: Such VENTILATORS can also be used for PATIENTS who are not dependent on ventilatory support.
NOTE 2: In the HOME HEALTHCARE 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 accessories can 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 IEC 60601 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 emergency 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 breathing patients), 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.
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.
IEC 60601 1:2005+AMD1:2012, 1.3 applies with the following addition:
This part of ISO 80601 refers to those applicable collateral standards that are listed in IEC 60601 1:2005+AMD1:2012, Clause 2, as well as 201.2 of this part of ISO 80601.
IEC 60601 1 3:2008 does not apply.
IEC 60601 1:2005+AMD1:2012, 1.4 is replaced by:
In the IEC 60601 series, particular standards can modify, replace, or delete requirements contained in the general standard, including the collateral standards, as appropriate for the particular me equipment under consideration, and may add other basic safety or essential performance requirements.
A requirement of a particular standard takes priority over IEC 60601 1:2005+AMD1:2012 or the collateral standards.
For brevity, IEC 60601 1:2005+AMD1:2012 is referred to in this part of ISO 80601 as the general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this part of ISO 80601 corresponds to those of the general standard with the prefix "201" (e.g. 201.1 in this part of ISO 80601 addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix "2xx" where xx is the final digits of the collateral standard document number (e.g. 202.4 addresses the content of IEC 60601 1 2, Clause 4 collateral standard, 208.4 addresses the content of IEC 60601 1 8, Clause 4 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:
- "Replacement" means that the clause or subclause of IEC 60601 1:2005+AMD1:2012 or the applicable collateral standard is replaced completely by the text of this part of ISO 80601.
- "Addition" means that the text of this particular standard is additional to the requirements of IEC 60601 1:2005+AMD1:2012 or the applicable collateral standard.
- "Amendment" means that the clause or subclause of IEC 60601 1:2005+AMD1:2012 or the applicable collateral standard is amended as indicated by the text of this part of ISO 80601.
Subclauses or figures that are additional to those of the general standard are numbered starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for IEC 60601 1 2, 203 for IEC 60601 1 3, etc.
The term "this standard" is used to make reference to IEC 60601 1:2005+AMD1:2012, any applicable collateral standards, and this part of ISO 80601 taken together.
Where there is no corresponding clause or subclause in this part of ISO 80601, the clause or subclause of IEC 60601 1:2005+AMD1:2012 or the applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601 1:2005+AMD1:2012 or the applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this part of ISO 80601.