General Information

Abstract

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.

Status
Withdrawn
Publication Date
08-Apr-2001
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
Not Harmonized93/42/EEC - Medical devices
OJ Ref: C, C 173/2, C 293/39, C 123/02 OJ Date: 27-Apr-2012

Buy Documents

Standard

EN 60601-1-1:2002 - SIST EN 60601-1-1:2002 je veljaven do 31. 12. 2018. SIST EN 60601-1:2007 ga nadomešča, oba sta v tem obdobju veljavna.

English language (33 pages)
Preview
Preview
e-Library read for
1 day

Relations

Effective Date
29-Jan-2023
Effective Date
29-Jan-2023
Effective Date
28-Jan-2023
Effective Date
09-Feb-2026
Effective Date
09-Feb-2026
Effective Date
03-Feb-2026
Effective Date
03-Feb-2026
Effective Date
03-Feb-2026
Effective Date
03-Feb-2026
Effective Date
03-Feb-2026
Effective Date
03-Feb-2026
Effective Date
03-Feb-2026
Effective Date
03-Feb-2026
Effective Date
03-Feb-2026
Effective Date
03-Feb-2026

Buy Documents

Standard

EN 60601-1-1:2002 - SIST EN 60601-1-1:2002 je veljaven do 31. 12. 2018. SIST EN 60601-1:2007 ga nadomešča, oba sta v tem obdobju veljavna.

English language (33 pages)
Preview
Preview
e-Library read for
1 day

Get Certified

Connect with accredited certification bodies for this standard

BSI Group

BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.

UKAS United Kingdom Verified

TÜV Rheinland

TÜV Rheinland is a leading international provider of technical services.

DAKKS Germany Verified

TÜV SÜD

TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.

DAKKS Germany Verified

Sponsored listings

Frequently Asked Questions

EN 60601-1-1:2001 is a standard published by CLC. Its full title is "Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems". This standard covers: 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.

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.

EN 60601-1-1:2001 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 60601-1-1:2001 has the following relationships with other standards: It is inter standard links to EN 60601-1-1:1993/A1:1996, EN 60601-1-1:1993, EN 60601-1:2006, EN ISO 8185:1997, EN ISO 8359:2009, EN 60950:2000, EN 61010-1:1993, EN 60825-1:1994/A1:2002, EN 61010-1:1993/A2:1995, EN 60825-1:1994, EN 60601-1:1990/A1:1993, EN 60335-1:1994, EN 60601-1:1990/A2:1995, EN 60065:1998, EN 60335-1:1994/A1:1996. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 60601-1-1:2001 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/432. 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 60601-1-1:2001 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)


SLOVENSKI STANDARD
01-februar-2002
1DGRPHãþD
SIST EN 60601-1-1:1995
SIST EN 60601-1-1:1995/A1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQHYDUQRVWQH]DKWHYH
6SUHPOMHYDOQLVWDQGDUG9DUQRVWQH]DKWHYH]DPHGLFLQVNHHOHNWULþQHVLVWHPH ,(&

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
...