Matériel médical électrique - Partie 2-30: Exigences particulières pour la sécurité, incluant les performances essentielles, du cycle automatique non invasive Blood Pressure Monitoring Equipment

Scope and object

This clause of the General Standard applies except as follows:

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 2.102, 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 av oidance of hazards due to the inflation process.

1.3 Particular Standards

Addition:

This Particular Standard refers to IEC 60601-1: 1988, Medical electrial equipment - Part 1: General requirements for safety, as amended by its amendment 1 (1991) and amendment 2 (1995). The General Standard also takes into account IEC 60601-1-2: 1993, Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests, and IEC 60601-1-4:1996, Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral Standard: Programmable elecrical 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 thei 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 Stnadard are numbered starting from 101, additional annexes are lettered AA, BB, etc., 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.