iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CLC

EN 60601-1:1990/A2:1995

(Amendment)

Medical electrical equipment - Part 1: General requirements for safety

Medical electrical equipment - Part 1: General requirements for safety

EN following parallel vote * Incorporates and supersedes A11 and A12

Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit

Appareils électromédicaux - Partie 1: Règles générales de sécurité

Medical electrical equipment - Part 1: General requirements for safety - Amendment A2 (IEC 60601-1:1988/A2:1995 + ccorigendum jun. 1995)

General Information

Status
Withdrawn
Publication Date
15-Jun-1995
Withdrawal Date
31-May-2012
ICS
11.040 - Medical equipment
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
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
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 60601-1:1995/A2:1998 - Medical electrical equipment -- Part 1: General requirements for safety

Relations

Replaced By
EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Effective Date
28-Jan-2023
Amends
EN 60601-1:1990 - Medical electrical equipment - Part 1: General requirements for safety
Effective Date
28-Jan-2023

Buy Standard

EN 60601-1:1995/A2:1998EN 60601-1:1995/A2:1998
PreviousNext
Amendment
EN 60601-1:1995/A2:1998
English language
53 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


SLOVENSKI SIST EN 60601-1:1995/A2:1998
prva izdaja
STANDARD
september 1998
Medical electrical equipment - Part 1: General requirements for safety -
Amendment A2 (IEC 60601-1:1988/A2:1995 + ccorigendum jun. 1995)
ICS 11.040.01 Referenčna šte
...

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 60601-1:2006/A13:2024(Amendment)
Medical electrical equipment - Part 1: General requirements for safety
SIST EN 60601-1:2007/A13:2024

Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

  • Amendment
    48 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-35:2021/A1:2024(Amendment)
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
SIST EN IEC 60601-2-35:2021/A1:2024
  • Amendment
    10 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 60601-2-76:2019/A1:2023(Amendment)
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
SIST EN IEC 60601-2-76:2019/A1:2023
  • Amendment
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-1:2006/A2:2021(Amendment)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SIST EN 60601-1:2007/A2:2021

2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant

  • Amendment
    58 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-1-10:2008/A2:2021(Amendment)
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
SIST EN 60601-1-10:2008/A2:2021

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/432

  • Amendment
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-1-6:2010/A2:2021(Amendment)
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
SIST EN 60601-1-6:2010/A2:2021

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) , 90/385/EEC (AIMD) and M/295

  • Amendment
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-1-9:2008/A2:2020(Amendment)
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
SIST EN 60601-1-9:2008/A2:2020

2020-10-13_JO_CLC/TC 62 Decision  2019-05-21/22 in Oslo to remove the link to the published standard

  • Amendment
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-1-12:2015/A1:2020(Amendment)
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
SIST EN 60601-1-12:2015/A1:2020

2020-10-13:JO-CLC/TC 62 Decision  2019-05-21/22 in Oslo to remove the link to the published standard

  • Amendment
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 62366-1:2015/A1:2020(Amendment)
Medical devices - Part 1: Application of usability engineering to medical devices
SIST EN 62366-1:2015/A1:2020

2019-04-04-JO-: link to legislation to the MDD 93/42/EEC and mandate M/432 removed following CLC/BT decision D162/C076

  • Amendment
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 80601-2-30:2019(Main)
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
SIST EN IEC 80601-2-30:2019

NEW!IEC 80601-2-30:2018 is available as IEC 80601-2-30:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-30:2018 applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as ME equipment, which by means of an inflatable cuff, are used for non continuous indirect estimation of the blood pressure without arterial puncture. This document specifies requirements for the basic safety and essential performance for this ME equipment and its accessories, including the requirements for the accuracy of a determination. This document covers automatic electrically-powered ME equipment used for the intermittent, indirect estimation of the blood pressure without arterial puncture, including blood pressure monitors for the home healthcare environment. Requirements for indirect estimation of the blood pressure without arterial puncture ME equipment with an electrically-powered pressure transducer and/or displays used in conjunction with a stethoscope or other manual methods for determining blood pressure (non-automated sphygmomanometers) are specified in document ISO 81060-1. 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 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. This second edition cancels and replaces the first edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 , and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015; b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12; c) changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series; d) added additional requirements for public self-use sphygmomanometers; e) added a list of primary operating functions.

  • Standard
    61 pages
    English language
    sale 10% off
    e-Library read for
    1 day