IEC 60601-2-30:1999 pdf download.Medical electrical equipment – Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
1 Scope and object
This clause of the General Standard applies except as follows:
*1.1 Scope
Addition:
This Particular Standard specifies requirements for the safety, including essential performance,
of AUTOMATIC CYCLING NON – INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in
2.1 02, hereinafter referred to as EQUIPMENT . The EQUIPMENT may be attended or unattended.
This Particular Standard does not apply to blood pressure measuring equipment which uses
finger transducers or to semi-automatic blood pressure measuring equipment, typically in which
each determination needs to be initiated manually.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety,
including essential performance, of AUTOMATIC CYCLING NON – INVASIVE BLOOD PRESSURE
MONITORING EQUIPMENT , with special attention being paid to the avoidance of hazards due to
the inflation process.
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601 -1 : 1 988, Medical electrical equipment – Part 1 :
General requirements for safety, as amended by its amendment 1 (1 991 ) and amendment 2
(1 995). The General Standard also takes into account IEC 60601 -1 -2: 1 993, Medical electrical
equipment – Part 1 : General requirements for safety – 2. Collateral Standard: Electromagnetic
compatibility – Requirements and tests, and IEC 60601 -1 -4:1 996, Medical electrical equipment
– Part 1 : General requirements for safety – 4. Collateral Standard: Programmable electrical
medical systems.
For brevity, IEC 60601 is referred to in this Particular Standard either as the “General
Standard” or as the “General Requirement(s)”.
The term “this Standard” is used to make reference to the General Standard and this Particular
Standard taken together.
The numbering of sections, clauses or 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 which are additional to those of the General Standard are numbered starting from 1 01 , additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Where there is no corresponding section, clause or subclause in this Particular 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 Particular Standard. The requirements of this Particular Standard take priority over those of the General Standard and Collateral Standards mentioned above.
2 Terminology and definitions
This clause of the General Standard applies except as follows:
2.1.5 APPLIED PART
Replacement:
The occluding cuff and any integral transducers, their connecting leads and pressure tubes.
Additional definitions:
2.101 ALARM
A signal which indicates abnormal events occurring to the PATIENT or EQUIPMENT .
2.102 AUTOMATIC CYCLING NON – INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT ( EQUIPMENT )
A device, or part of a physiological monitoring or measuring system, including its associated
accessories used for intermittent assessment of a PATIENT ’s blood pressure by an externally
applied means.
2.103 INHIBITION
Disabling or SILENCING and disabling an ALARM until revoked intentionally.
2.104 LATCHED ALARM
An ALARM , the visual and auditory manifestation of which does not stop when the parameter
(which caused the alarm) returns to a value which no longer exceeds the alarm limit or if the
abnormal PATIENT condition does not exist any longer.
IEC 60601-2-30:1999 pdf download
