IEC 60601-2-21:2009/COR1:2013
(Corrigendum)Corrigendum 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
General Information
- Abstract
- Status
- Published
- Publication Date
- 24-Feb-2013
- Technical Committee
- SC 62D - Particular medical equipment, software, and systems
- Current Stage
- DELPUB - Deleted Publication
- Start Date
- 29-Sep-2020
- Completion Date
- 28-Aug-2026
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IEC 60601-2-21:2009/COR1:2013 - Corrigendum 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers Released:2/25/2013
Relations
- Effective Date
- 05-Sep-2023
- Effective Date
- 05-Sep-2023
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IEC 60601-2-21:2009/COR1:2013 - Corrigendum 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers Released:2/25/2013
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Frequently Asked Questions
IEC 60601-2-21:2009/COR1:2013 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Corrigendum 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers". This standard covers: Corrigendum 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Corrigendum 1 - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC 60601-2-21:2009/COR1:2013 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC 60601-2-21:2009/COR1:2013 has the following relationships with other standards: It is inter standard links to IEC 60601-2-21:2009, IEC 60601-2-21:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
IEC 60601-2-21:2009/COR1:2013 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
IEC 60601-2-21 CEI 60601-2-21
(Second edition – 2009) (Deuxième édition – 2009)
Medical electrical equipment – Appareils électromédicaux –
Part 2-21: Particular requirements for Partie 2-21: Exigences particulières pour
the basic safety and essential performance la sécurité de base et les
of infant radiant warmers performances essentielles des incubateurs
radiants pour nouveau-nés
CO RRI G ENDU M 1
*
201.9.6.2.1.101 Audible alarms 201.9.6.2.1.101 *Niveau sonore
sound level des alarmes sonores
Replace, in the first paragra
...
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NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
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- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
- ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79;
- sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
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- high-frequency oscillatory ventilators (HFOVs);
- respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
- user-powered resuscitators, which are given in ISO 10651-4;
- gas-powered emergency resuscitators, which are given in ISO 10651-5;
- oxygen therapy constant flow ME equipment; and
- cuirass or “iron-lung” ventilation equipment.
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NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, hereafter also referred to as ME equipment, in combination with its accessories:
- intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.
- intended for use by a lay operator;
- intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and
- not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD).
Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm 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.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
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- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
- ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
- sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
- high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
- high-frequency oscillatory ventilators (HFOVs);
- respiratory high flow equipment, which are given in ISO 80601‑2‑90;
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- user-powered resuscitators, which are given in ISO 10651-4;
- gas-powered emergency resuscitators, which are given in ISO 10651-5;
- oxygen therapy constant flow ME equipment; and
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