Medical electrical equipment. Part 2-12: Particular requirements for the safety of lung ventilators. Critical care ventilators (IEC 60601-2-12:2001)
1.1 Scope Addition: This Particular Standard specifies the safety requirements for VENTILATORS, as defined in 2.1.125, intended for use in critical care settings. Continuous positive airway pressure (CPAP) devices, sleep apnea therapy devices, supportcare VENTILATORs, emergency and transport VENTILATORs, jet and high frequency VENTILATORs and oscillators are outside the scope of this Particular Standard, nor are devices that may be used within hospitals, intended solely to augment the ventilation of spontaneously breathing PATIENTS. Standards for other types of VENTILATORs, e.g. high frequency jet and oscillation ventilators, are under consideration. Requirements for VENTILATORs intended for anaesthetic applications are given in IEC 60601-2-13. 1.2 Object Addition: The object of this standard is to specify particular safety requirements for VENTILATORS intended for use in critical care settings. 1.3 Particular standards Addition: This Particular Standard refers to IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety, as amended by its amendment 1 (1991) and its amendment 2 (1995), herein referred to as the “General Standard”. The General Standard takes into account a set of Collateral Standards: IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requirements for safety, Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-2:2001, Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety, 4. Collateral standard: Programmable electrical medical systems Amendment 11 The term “this Standard” covers this Particular Standard, used together with the General Standard and the Collateral Standards. The numbering of sections, clauses, and subclauses of this Particular Standard corresponds with that of the General Standard. 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 the General Standard is replaced completely by the text of this Particular Standard. – “Addition” means that the text of this Particular Standard is additional to the requirements of the General Standard. – “Amendment” means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Subclauses or figures that are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Clauses and subclauses to which there is a rationale are marked with an asterisk *. These rationales can be found in an informative Annex AA. Annexes AA and CC are not normative parts of this Particular Standard and only provide additional information; they can never be the subjects of testing. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard or specified Collateral Standard applies without modification. Where it is intended that any part of the General Standard or Collateral Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. A requirement of this Particular Standard replacing or modifying requirements of the General Standard or a Collateral Standard takes precedence over the corresponding general requirement(s).
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