1 * Scope, object and related standards

1.1 Scope

ü        This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

ü         This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS.  It also provides guidance for the application of ALARM SYSTEMS.

1.2 Object

ü         The object of this collateral standard is to specify basic safety and essential performance requirements and tests for ALARM SYSTEMS in ME EQUIPMENT and ME SYSTEMS and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent ALARM SIGNALS and consistent control states and their marking for all ALARM SYSTEMS.

ü         This collateral standard does not specify:

whether any particular ME EQUIPMENT or ME SYSTEM is required to be provided with ALARM SYSTEMS;

the particular circumstances which initiate an ALARM CONDITION;

the allocation of priorities to a particular ALARM CONDITION; or

the means of generating ALARM SIGNALS.

1.3 Related standards

1.3.1 IEC 60601-1

ü         For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1.

ü         When referring to IEC 60601-1 or to this collateral standard, either individually or in combination, the following conventions are used:

– "the general standard" designates IEC 60601-1 alone;

– "this collateral standard" designates IEC 60601-1-8 alone;

– "this standard" designates the combination of the general standard and this collateral standard.

1.3.2 Particular standards

?       A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.

לא ברור מהו המושג particular standard, ומה המשמעות שהוא בעדיפות על פני תקן זה.

60601-1 הוא תקן כללי למכשור רפואי – קיימים תקנים ייחודיים particular standard למכשירים שונים כגון ECG, SPO2  או לדרישות ייחודיות כמו למשל "תוכנה רפואית".

דברים שנקבעו עבוד פרמטר מסויים עדיפים על דרישות כלליות הנוגעות לכלל המכשירים הרפואיים.