iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CLC

EN 60601-2-19:1996

(Main)

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

This standard establishes safety requirements for baby incubators with the view to minimizing hazards to the patient and user. It also specifies tests by which compliance requirements can be verified. It does not apply to transport incubators nor infant radiant warmers which are covered in other publications.

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

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

Etablit des règles pour la sécurité des incubateurs pour bébés en vue de réduire les risques vis-à-vis du patient et de l'utilisateur. Elle spécifie également des essais pour la vérification de la conformité aux prescriptions. Elle ne s'applique pas aux incubateurs radiants ou de transport.

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

General Information

Status
Withdrawn
Publication Date
09-Dec-1996
Withdrawal Date
09-Jun-1997
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
IEC/SC 62D - IEC_SC_62D
Parallel Committee
IEC/SC 62D - IEC_SC_62D
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
01-Apr-2012
Completion Date
01-Apr-2012
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
Ref Project
SIST EN 60601-2-19:1998 - Medical electrical equipment -- Part 2: Particular requirements for the safety of baby incubators

Relations

Replaces
HD 395.2.19 S1:1992 - Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators
Effective Date
28-Jan-2023
Replaced By
EN 60601-2-19:2009 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Effective Date
28-Jan-2023
Amended By
EN 60601-2-19:1996/A1:1996 - Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators
Effective Date
29-Jan-2023

Buy Standard

EN 60601-2-19:1998EN 60601-2-19:1998
PreviousNext
Standard
EN 60601-2-19:1998
English language
32 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


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

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CLC
EN IEC 60601-2-21:2021/A1:2023(Amendment)
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
SIST EN IEC 60601-2-21:2021/A1:2024
  • Amendment
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-20:2020/A1:2023(Amendment)
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
SIST EN IEC 60601-2-20:2020/A1:2024
  • Amendment
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-19:2021/A1:2023(Amendment)
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
SIST EN IEC 60601-2-19:2021/A1:2024
  • Amendment
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-19:2021(Main)
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
SIST EN IEC 60601-2-19:2021

IEC 60601-2-19:2020 is available as IEC 60601-2-19:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-19:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, 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 document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-19:2020 specifies safety requirements for INFANT 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. IEC 60601-2-19:2020 does not apply to: - INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-19:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-19:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

  • Standard
    42 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-21:2021(Main)
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
SIST EN IEC 60601-2-21:2021

IEC 60601-2-21:2020 is available as IEC 60601-2-21:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-21:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, 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 document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-21:2020 specifies the safety requirements for INFANT RADIANT WARMERS, 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 60601-2-35; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; - INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

  • Standard
    40 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-20:2020(Main)
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
SIST EN IEC 60601-2-20:2020

IEC 60601-2-20:2020 is available as IEC 60601-2-20:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-20:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.208, 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 document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-20:2020 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 60601-2-35; - INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50. IEC 60601-2-20:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-20:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

  • Standard
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-2-4:2011/A1:2019(Amendment)
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
SIST EN 60601-2-4:2011/A1:2019

NEXT ACTION: PUBLICATION EXPECTED BY 2019-10-31
2019-07-04 IP: BT decision D163/C033 - remove link to MDD  
NEXT ACTION: TB Action by 21-22 May 2019 i.e. Next CLC TC 62 Plenary Meeting
2019-01-16 JO - In contact with CLC TC 62 to know if they will take a ballot to decouple this WI (upon  BT approval)  and proceed to PUB

  • Amendment
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-2-4:2011(Main)
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
SIST EN 60601-2-4:2011

IEC 60601-2-4:2010 establishes particular basic safety and essential performance requirements for cardiac defibrillators. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes.

  • Standard
    80 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-2-12:2006(Main)
Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
SIST EN 60601-2-12:2006

Specifies the safety requirements for ventilators, as defined below, intended for use in critical care settings. Ventilator: automatic equipment that is intended to augment or provide ventilation of the lungs of the patient when connected to the airway of the patient.

  • Standard
    49 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
prEN 50447(Main)
Active implantable medical devices - Particular requirements for Heart-Lung Machines (HLM)
oSIST prEN 50447:2005

D127/107: Project under Benchemark 6 * Extension of target date approved until 2007-09-12 (no more extension allowed) * TC 62 decision on 2006-10-24: prEN 50447 deleted from work programme due to lack of sustained interest from stakeholders * D129/C066: Cancellation of project confirmed * Standstill released

  • Draft
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day