Scope and object
This clause of the General Standard and this clause of the Collateral Standard IEC 60601-1-2 apply, except as follows:
Scope
Addition:
This Particular Standard specifies the requirement for INFUSION PUMPS, INFUSION CONTROLLERS, SYRINGE PUMPS and PUMPS FOR AMBULATORY USE, as defined in 2.101 to 2.110. These devices are intended for use by medical staff and home PATIENTS as prescribed and medically indicated. These particular requirements do not apply to devices:
1) specifically intended for diagnostic or similar use (e.g. an-geography or other pumps permanently controlled or supervised by the OPERATOR),
2) enteral infusion,
3) extra-corporeal circulation of blood,
4) implantable or disposable devices,
5) EQUIPMENT specifically intended for diagnostic use within aerodynamic (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water);
6) EQUIPMENT specifically intended for diagnostic use within male potency testing (measurement of amount of liquid infused, necessary to maintain a preset level for maintaining penile erection: cavernosometry, cavernosography).
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 amendment 2 (1995) and to the Collateral Standard IEC 60601-1-2:1993, Medical electrical equipment - Part 1: General requirements for safety -2. Collateral Standard: Electromagnetic compatibility - Requirements and tests.
For brevity, Part 1 is referred to in this Particular Standard either as the General Standard or as the General Requirement(s) and IEC 60601-1-2 as the Collateral Standard.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to 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 replaces 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 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, the Collateral Standard and this Particular Standard taken together.Where there is no corresponding section, clause or sub clause in this Particular Standard, the section, clause or sub clause of the General Standard, although possibly not relevant, applies without modification; where it is intended that any part of the General Standard, although possibly not relevant, is not to be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard take priority over those of the General Standard.
The requirements are followed by specifications for the relevant tests.
Following the decision taken by subcommittee 62D at the meeting in Washington in 1979, a General guidance and rationale section giving some explanatory notes, where appropriate, about the more important requirements is included in annex AA.Clauses or subclauses for which there are explanatory notes in annex AA are marked with an asterisk ().
It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this Standard.
1.5 Collateral Standards
Addition:
This Particular Standard also refers to IED 60601-1-2, which is applicable unless otherwise stated in a particular clause or subclause.