EN 60601-1-4:1996/A1:1999

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

EN following parallel vote

Medizinische elektrische Geräte - Teil 1-4: Allgemeine Festlegungen für die Sicherheit - Ergänzungsnorm: Programmierbare elektrische medizinische Systeme

Appareils électromédicaux - Partie 1-4: Règles générales de sécurité - Norme collatérale: Systèmes électromédicaux programmables

Medicinska električna oprema - 1. del: Splošne varnostne zahteve - 4. spremljevalni standard: Programirljivi električni medicinski sistemi - Dopolnilo A1(IEC 60601-1-4:1998)

General Information

• Status: Withdrawn
• Publication Date: 08-Dec-1999
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/TC 62 - IEC_TC_62
• Parallel Committee: IEC/TC 62 - IEC_TC_62
• 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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to 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 60601-1-4:1998/A1:2002 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1998)

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 60601-1-4:1996 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2002
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Medical electrical equipment - Part 1-4: General requirements for safety - Collateral
standard: Programmable electrical medical systems (IEC 60601-1-4:1998)
Medizinische elektrische Geräte - Teil 1-4: Allgemeine Festlegungen für die Sicherheit -
Ergänzungsnorm: Programmierbare elektrische medizinische Systeme (IEC 60601-1-
4:1998)
Appareils électromédicaux - Partie 1-4: Règles générales de sécurité - Norme
collatérale: Systèmes électromédicaux programmables (CEI 60601-1-4:1998)
Ta slovenski standard je istoveten z: EN 60601-1-4:1996/A1:1999
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

NORME CEI
INTERNATIONALE IEC
60601-1-4
INTERNATIONAL
STANDARD
AMENDEMENT 1
AMENDMENT 1
1999-10
Amendement 1
Appareils électromédicaux –
Partie 1-4:
Règles générales de sécurité –
Norme collatérale: Systèmes électromédicaux
programmables
Amendment 1
Medical electrical equipment –
Part 1-4:
General requirements for safety – Collateral
standard: Programmable electrical medical
systems
 IEC 1999 Droits de reproduction réservés  Copyright - all rights reserved
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
H
PRICE CODE
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

60601-1-4 Amend. 1 © IEC:1999 – 3 –
FOREWORD
This amendment has been prepared by IEC technical committee 62: Electrical equipment in
medical practice.
The text of this amendment is based on the following documents:
FDIS Report of voting
62/114/FDIS 62/120/RVD
Full information on the voting for the approval of this amendment can be found in the report on
voting indicated in the above table.
–––––––––––––
Page 3
CONTENTS
Replace title of annex DDD by the following:
DDD DEVELOPMENT LIFE-CYCLE. 49
Page 9
INTRODUCTION
Replace the third dash by the following:
– methods by which SAFETY is assured;
Page 15
AFETY INTEGRITY
2.201.12 S :
Replace this definition by the following:
2.201.12 Not used.
Page 17
6 Identification, marking and documents
6.8 ACCOMPANYING DOCUMENTS
Replace 6.8.201 by the following:
6.8.201 All relevant information regarding significant RESIDUAL RISK including descriptions of
the HAZARDS and any actions by the OPERATOR or the USER necessary to avoid/mitigate them
INSTRUCTIONS FOR USE RISK MANAGEMENT FILE
shall be placed in both the and the .

60601-1-4 Amend. 1 © IEC:1999 – 5 –
Add the following new subclause 6.8.202:
6.8.202 ACCOMPANYING DOCUMENTS for the PEMS shall identify, as a minimum, the
MANUFACTURER and a unique identifier such as revision level and date of release/issue.
NOTE Information pertaining to any specific EQUIPMENT that software is intended to be used in conjunction with,
and a means by which the MANUFACTURER can be contacted, can be located on the package or in the INSTRUCTIONS
FOR USE so that it is available to the USER independently of the software operation.
52 Abnormal operation and fault conditions
52.201.3c)
Replace 52.201.3 c) by the following:
c) reference to the SAFETY measures, used to eliminate or control the RISK of the HAZARD;
Page 19
Figure 201
Amend the box "VALIDATION methods and results 52.210.6" to "VALIDATION methods and results
52.210.7".
Amend the box "VERIFICATION plan 52.210.2" to "VALIDATION plan 52.210.2".
Amend, within the lower right-hand corner of the figure, the text "VERIFICATION methods and
VERIFICATION
results 52.209.3" to "Methods, techniques and results of the 52.209.4".
Page 21
52.203 DEVELOPMENT LIFE-CYCLE
Add the following new subclause 52.203.6:
52.203.6 Where appropriate, a defined system for problem resolution within and between all
phases and tasks of the DEVELOPMENT LIFE CYCLE shall be developed and maintained as part of
RISK MANAGEMENT FILE
the . Depending upon the problem, the system may have the following
characteristics:
– be defined as a part of the DEVELOPMENT LIFE-CYCLE;
– allow the reporting of potential or existing SAFETY and/or performance problems;
– include an assessment of each problem for associated RISKS;
– identify the criteria (SAFETY and/or performance) that have to be met for the issue to be
closed;
– identify the action to be taken to resolve each problem;
– identify VALIDATION methods for each action;
– identify the steps taken for VERIFICATION of continuing compliance.

60601-1-4 Amend. 1 © IEC:1999 – 7 –
Page 21
52.204.3.1 HAZARD ANALYSIS
Replace on page 23, in subclause 52.204.3.1.5, the first dash by the following:
– human factors including ergonomic limitations;
Page 25
52.204.4 RISK control
Add, in subclause 52.204.4.3, the following new sentence:
The likelihood that the means for RISK reduction will perform correctly shall be specified
quantitatively or qualitatively; see annex CCC.
52.206 Requirement specification
Replace 52.206.3 by the following new subclause 52.206.3:
52.206.3 The requirement specification shall include the information necessary to assure that
RISK control measures satisfactorily reduce the identified RISKS.
Page 27
52.207 Architecture
Replace 52.207.3 by the following new subclause 52.207.3:
52.207.3 Where appropriate, the architecture specification of a PEMS and its subsystems shall
address the RISK CONTROL requirements by reducing the corresponding likelihood of the HAZARD
or by reducing the SEVERITY of the HAZARD or both.
Add the following new subclauses 52.207.4 and 52.207.5:
52.207.4 Where appropriate, to reduce the likelihood of the HAZARD, the architecture
specification shall make use of:
a) highly reliable components;
b) fail-safe functions;
c) redundancy;
d) diversity;
e) defensive design;
f) limits on potentially hazardous effects, for example by restricting the available output power
and/or by introducing means to limit the travel of actuators.

60601-1-4 Amend. 1 © IEC:1999 – 9 –
52.207.5 The architecture specification shall take the following into consideration:
a) allocation of RISK control measures to subsystems and components of the PEMS;
...