EN 864:1996
(Main)Medical electrical equipment - Capnometers for use with humans - Particular requirements
Medical electrical equipment - Capnometers for use with humans - Particular requirements
Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following: 1.1 This European Standard specifies requirements for the safety of capnometers as defined in 3.6 of this standard. It applies to capnometers used with adults, children, and neonates. It does not apply to devices intended for use as transcutaneous monitors. Capnometers intended for use in laboratory research applications are outside the scope of this standard.
Medizinische elektrische Geräte - Kapnometer für die Anwendung am Menschen - Besondere Anforderungen
Abschnitt 1 von EN 60601-1:1990 gilt mit der Ausnahme, daß 1.1 durch folgendes ersetzt wird: 1.1 Diese Europäische Norm legt Anforderungen an die Sicherheit von Kapnometern fest, die in 3.6 dieser Norm definiert sind. Sie gilt für Kapnometer zur Anwendung an Erwachsenen, Kindern und Neugeborenen. Sie gilt nicht für Geräte, die als transkutane Überwachungsgeräte benutzt werden. Kapnometer zur Verwendung bei Laboruntersuchungen gehören nicht zum Anwendungsbereich dieser Norm.
Appareils électromédicaux - Capnomètres pour utilisation chez l'homme - Prescriptions particulières
L'article 1 de l'EN 60601-1:1990 s'applique, exception faite du 1.1 qui est remplacé par le texte suivant: 1.1 La présente norme européenne spécifie les prescriptions de sécurité relatives aux capnomètres, définis au 3.6 de la présente norme. Elle s'applique aux capnomètres utilisés pour les adultes, les enfants et les nouveaux-nés. Elle ne s'applique pas aux dispositifs destinés à être utilisés comme appareillage de surveillance transcutanée. Les capnomètres destinés à être utilisés pour des applications de recherche en laboratoire n'entrent pas dans le domaine d'application de la présente norme.
Elektromedicinska oprema - Merilniki CO2 (kapnometri) za uporabo pri ljudeh - Posebne zahteve
General Information
- Status
- Withdrawn
- Publication Date
- 22-Oct-1996
- Withdrawal Date
- 14-Nov-2004
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 2 - Lung ventilators
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Nov-2004
- Completion Date
- 15-Nov-2004
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 864:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical electrical equipment - Capnometers for use with humans - Particular requirements". This standard covers: Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following: 1.1 This European Standard specifies requirements for the safety of capnometers as defined in 3.6 of this standard. It applies to capnometers used with adults, children, and neonates. It does not apply to devices intended for use as transcutaneous monitors. Capnometers intended for use in laboratory research applications are outside the scope of this standard.
Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following: 1.1 This European Standard specifies requirements for the safety of capnometers as defined in 3.6 of this standard. It applies to capnometers used with adults, children, and neonates. It does not apply to devices intended for use as transcutaneous monitors. Capnometers intended for use in laboratory research applications are outside the scope of this standard.
EN 864:1996 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.
EN 864:1996 has the following relationships with other standards: It is inter standard links to EN ISO 21647:2004. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 864:1996 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 864:1996 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)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Elektromedicinska oprema - Merilniki CO2 (kapnometri) za uporabo pri ljudeh - Posebne zahteveMedizinische elektrische Geräte - Kapnometer für die Anwendung am Menschen - Besondere AnforderungenAppareils électromédicaux - Capnometres pour utilisation chez l'homme - Prescriptions particulieresMedical electrical equipment - Capnometers for use with humans - Particular requirements11.040.50Radiografska opremaRadiographic equipmentICS:Ta slovenski standard je istoveten z:EN 864:1996SIST EN 864:2000en01-januar-2000SIST EN 864:2000SLOVENSKI
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