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.