Standard Swedish standard · SS-EN ISO 80601-2-12:2011

Medical Electrical Equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011)

Status: Withdrawn · Replaced by: SS-EN ISO 80601-2-12:2020 Corrected by: SS-EN ISO 80601-2-12:2011/AC:2011

Scope
201.1 Scope, object and related standards

IEC 60601-1:2005, Clause 1 applies, except as follows:

201.1.1 Scope

Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT:
- intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and

NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.

- intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.

NOTE 2 A critical care VENTILATOR intended for use in transport within a professional healthcare facility is not considered an emergency and transport ventilator.

This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYSTEM, or to a VENTILATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR.

This International Standard is not applicable to ME EQUIPMENT or an ME SYSTEM operating in ventilation modes intended for patients who are not dependent on mechanical ventilation.

NOTE 3 A critical care VENTILATOR, when operating in such a mode, is not considered LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

Subjects

Anaesthetic, respiratory and reanimation equipment (11.040.10)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-80533

Edition: 1

Approved: 5/31/2011

No of pages: 100

Replaces: SS-EN 794-1+A2:2009

Replaced by: SS-EN ISO 80601-2-12:2020