SIST EN 60601-2-31:1995

Medical electrical equipment -- Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source

Specifies the particular safety requirements for external pacemakers powered by an internal electrical power source. Applies also to patient cables but does not apply to equipment which can be directly or indirectly connected to a supply mains.

Medizinische elektrische Geräte -- Teil 2-31: Besondere Festlegungen für die Sicherheit von externen Herzschrittmachern mit interner Stromversorgung

Appareils électromédicaux -- Partie 2-31: Règles particulières de sécurité des stimulateurs cardiaques externes à source d'énergie interne

Spécifie les règles particulières de sécurité des stimulateurs externes qui sont alimentés par une source électrique interne. S'applique également aux câbles patient mais ne s'applique pas aux appareils qui peuvent être directement ou indirectement reliés à un réseau d'alimentation.

Medical electrical equipment Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source (IEC 601-2-31:1994)

General Information

• Status: Withdrawn
• Publication Date: 30-Apr-1995
• Withdrawal Date: 24-Sep-2008
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 23-Sep-2008
• Due Date: 16-Oct-2008
• Completion Date: 25-Sep-2008
• 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 60601-2-31:1995 - Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source

Relations

• Revised: SIST EN 60601-2-31:2008 - Medical electrical equipment -- Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• Effective Date: 07-Jun-2011
• Replaced By: SIST EN 60601-2-31:2008 - Medical electrical equipment -- Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• Effective Date: 29-Jan-2023
• Amended By: SIST EN 60601-2-31:1995/A1:1998 - Medical electrical equipment -- Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
• Effective Date: 29-Jan-2023
• Replaced By: SIST EN 60601-2-31:2008 - Medical electrical equipment -- Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• Effective Date: 07-Jun-2022
• Amended By: SIST EN 60601-2-31:1995/A1:1998 - Medical electrical equipment -- Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
• Effective Date: 07-Jun-2022
• Replaced By: SIST EN 60601-2-31:2008 - Medical electrical equipment -- Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• Effective Date: 01-Nov-2008
• Amended By: SIST EN 60601-2-31:1995/A1:1998 - Medical electrical equipment -- Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
• Effective Date: 01-Sep-1995

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-31:1995
01-maj-1995
Medical electrical equipment Part 2: Particular requirements for the safety of
external cardiac pacemakers with internal power source (IEC 601-2-31:1994)
Medical electrical equipment -- Part 2-31: Particular requirements for the safety of
external cardiac pacemakers with internal power source
Medizinische elektrische Geräte -- Teil 2-31: Besondere Festlegungen für die Sicherheit
von externen Herzschrittmachern mit interner Stromversorgung
Appareils électromédicaux -- Partie 2-31: Règles particulières de sécurité des
stimulateurs cardiaques externes à source d'énergie interne
Ta slovenski standard je istoveten z: EN 60601-2-31:1995
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-31:1995 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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