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SIST

SIST EN 60601-2-19:1998/A1:1998

(Amendment)

Medical electrical equipment -- Part 2: Particular requirements for the safety of baby incubators

Medical electrical equipment -- Part 2: Particular requirements for the safety of baby incubators

EN following parallel vote

Medizinische elektrische Geräte -- Teil 2: Besondere Festlegungen für die Sicherheit von Säuglingsinkubatoren

Appareils électromédicaux -- Partie 2: Règles particulières de sécurité des incubateurs pour bébés

Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators - Amendment A1 (IEC 60601-2-19:1990/A1:1996)

General Information

Status
Withdrawn
Publication Date
31-Aug-1998
Withdrawal Date
09-Jun-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
09-Jun-2009
Due Date
02-Jul-2009
Completion Date
10-Jun-2009
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 60601-2-19:1996/A1:1996 - Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators

Relations

Amends
SIST EN 60601-2-19:1998 - Medical electrical equipment -- Part 2: Particular requirements for the safety of baby incubators
Effective Date
01-Sep-1998
Replaced By
SIST EN 60601-2-19:2009 - Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators (IEC 60601-2-19)
Effective Date
29-Jan-2023
Revised
SIST EN 60601-2-19:2009 - Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators (IEC 60601-2-19)
Effective Date
03-Apr-2012
Replaced By
SIST EN 60601-2-19:2009 - Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators (IEC 60601-2-19)
Effective Date
07-Jun-2022
Replaced By
SIST EN 60601-2-19:2009 - Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators (IEC 60601-2-19)
Effective Date
01-Jul-2009
Amends
SIST EN 60601-2-19:1998 - Medical electrical equipment -- Part 2: Particular requirements for the safety of baby incubators
Effective Date
29-Jan-2023
Amends
SIST EN 60601-2-19:1998 - Medical electrical equipment -- Part 2: Particular requirements for the safety of baby incubators
Effective Date
07-Jun-2022

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EN 60601-2-19:1998/A1:1998EN 60601-2-19:1998/A1:1998
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EN 60601-2-19:1998/A1:1998
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Standards Content (Sample)

SLOVENSKI SIST EN 60601-2-
19:1998/A1:1998
prva izdaja
STANDARD
september 1998
Medical electrical equipment - Part 2: Particular requirements for the safety of baby
incubators - Amendment A1 (IEC 60601-2-19:1990/A1:1996)
ICS 11.040.10 Referenčna
...

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This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.211 of this standard, also referred to as ME EQUIPMENT. 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This particular standard specifies safety requirements for INFANT TRANSPORT INCUBATORS but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information
see IEC 80601-2-35 [1]1);
– INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see
IEC 60601-2-19 [2];
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [3];
– INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50 [4].

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