Standard

NS-EN 12598:1999

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Abstract

This European Standard refers to IEC 60601-1:1988: Medical electrical equipment - Part 1 : General requirements for safety, as amended by its amendments 1 (1991) and 2 (1995). For brevity Part 1 is referred to in this European standard either as the General Standard or as the General requirements. The scope given in clause 1 of the General Standard applies except that 1.1 is replaced by the following: This European Standard provides particular requirements for oxygen monitors, as defined in clause 1.3.14 (in this specification) intended for use in determining the oxygen level in gas mixtures. Both diverting and non-diverting oxygen monitors are covered. The field of application includes, but is not limited to, a) anaesthetic workstations and breathing systems; b) ventilators; c) infant incubators; Oxygen monitors intended for use in laboratory research applications are outside the scope of this Standard. The requirements of clause 1.3 of the General Standard apply with the following addition: The numbering of clauses and subclauses of this European Standard corresponds to that of the General Standard, thereby, sections have become major clause numbers. 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 European Standard. ´Addition´ means that the text of this European 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 European Standard. Subclauses or figures which 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. The term ´this Standard´ is used to make reference to the General Standard and this European Standard taken together. Where there is no corresponding section, clause or subclause in this European Standard, the section, clause or subclause of the General Standard, although possibly not relevant, applies without modification, where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this European Standard.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 11.040.10
  • National Committee SN/K 122

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EU law: 93/42/EEC

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