EN 60601-1-1:2001

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

Applies to the safety of medical electrical systems, as defined as follows: combination of items of equipment, at least one of which must be medical electrical equipment and inter-connected by functional connection or use of a multiple portable socket-outlet. Describes the safety requirements necessary to provide protection for the patient, the operator and surroundings. Cancels and replaces the first edition published in 1992 and its amendment 1 (1995) and constitutes a technical revision.

Medizinische elektrische Geräte - Teil 1-1: Allgemeine Festlegungen für die Sicherheit - Ergänzungsnorm: Festlegungen für die Sicherheit von medizinischen elektrischen Systemen

Appareils électromédicaux - Partie 1-1: Règles générales de sécurité - Norme collatérale: Règles de sécurité pour systèmes électromédicaux

S'applique à la sécurité des systèmes électromédicaux, tels qu'ils sont définis ci-après: combinaison d'appareils, dont au moins un est un appareil électromédical, et qui sont raccordés entre eux par connexion fonctionnelle ou utilisation d'un socle mobile à prises multiples. Décrit les règles de sécurité nécessaires pour assurer la protection du patient, de l'opérateur et de l'environnement. Annule et remplace la première édition parue en 1992 et son amendement 1 (1995); elle constitue une révision technique.

Medicinska električna oprema - 1-1. del: Splošne varnostne zahteve - Spremljevalni standard: Varnostne zahteve za medicinske električne sisteme (IEC 60601-1-1:2000)

General Information

• Status: Withdrawn
• Publication Date: 08-Apr-2001
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Parallel Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 31-Dec-2018
• Completion Date: 31-Dec-2018
• 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 60601-1-1:2002 - Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)

Relations

• Replaces: EN 60601-1-1:1993/A1:1996 - Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems
• Effective Date: 29-Jan-2023
• Replaces: EN 60601-1-1:1993 - Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems
• Effective Date: 29-Jan-2023
• Replaced By: EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2002
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SIST EN 60601-1-1:1995
SIST EN 60601-1-1:1995/A1:1998
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Medical electrical equipment - Part 1-1: General requirements for safety - Collateral
standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)
Medizinische elektrische Geräte - Teil 1-1: Allgemeine Festlegungen für die Sicherheit -
Ergänzungsnorm: Festl
...