IEC 60601-1-4-2000 pdf free download – Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems.
1.203 Relationship to other standards1.203.1IEC 60601-1
For MEDICAL ELECTRICAL EQUIPMENT,this Collateral Standard complements lEC 60601-1 andits amendments.
When referring to lEC 60601-1 or to this Collateral Standard，either individually or incombination,the following conventions are used:
-“the General Standard” designates lEC 60601-1 alone;- “this Collateral Standard” designates lEC 60601-1-4 alone;
– “this Standard” designates the combination of the General Standard and this Collateral Standard.
1.203.2Particular Standards
A requirement in a Particular Standard takes priority over the corresponding requirement inthis Collateral Standard.
1.203.3 Normative references
The following normative documents contain provisions which，through reference in this text,constitute provisions of this International Standard. At the time of publication，the editionsindicated were valid. All normative documents are subject to revision， and parties toagreements based on this International Standard are encouraged to investigate the possibilityof applying the most recent editions of the normative documents indicated below.Members ofIEC and lso maintain registers of currently valid International Standards.
IEC 60601-1:1988,Medical electrical equipment – Part 1 : General requirements for safetyAmendment No.1 (1991)
Amendment No.2 (1995)
IEC 60601-1-1:1992,Medical electrical equipment – Part 1: General requirements for safety -1. Collateral Standard: Safety requirements for medical electrical systems
IEC 60788:1984，Medical radiology – Terminology
Iso 9000-3:1991,Quality management and quality assurance standards – Part 3: Guidelinesfor the application of lso 9o01 to the development, supply and maintenance of software
lso 9001:1994，Quality systems – Model for quality assurance in design，development.production, installation and servicing
2Terminology and definitions2.201 Defined terms
ln this Collateral Standard, terms printed in sMALL CAPITALS are used in accordance with theirdefinitions in the General Standard,IEC 60601-1-1, this Collateral Standard or lEC 60788.
An index of defined terms used in this Collateral Standard is given in annex AAA.For the purpose of this Collateral Standard, the following additional definitions apply.
2.201.1
DEVELOPMENT LIFE-cYcLE
necessary activities occurring during a period of time that starts at the concept phase of aproject and finishes when the VALIDATlON of the PEMs is complete
2.201.2
HAZARD ANALYSIs
identification of HAZARDs and their initiating causes
NOTE The quantification of HAzARD is not a part of the HAzARD ANALYSIS.
2.201.3
MAXIMUM TOLERABLE RISK
value of RISK which is specified as the maximum which may be permittedNOTE The value may be specified for the PEMs as a whole or for a particular HAZARD.
2.201.4
PROGRAMMABLE ELECTRICAL MEDICAL sYSTEM(PEMS)
MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM containing one or morePROGRAMMABLE ELECTRONIC suBsYSTEM
2.201.5
PROGRAMMABLE ELECTRONIC suesYSTEM (PESs)
system based on one or more central processing units, including their software and interfaces
2.201.6
RESIDUAL RISK
RISK identified by HAZARD ANALYSIS which remains after RIsK management has been completed
2.201.7
RISK
probable rate of occurrence of a HAZARD causing harm,and the degree of sEVERITY of theharm
2.201.8
RISK MANAGEMENT FILE
that part of the quality records required by this standard
2.201.9
RISK MANAGEMENT SUMMARY
document,which provides traceability for each HAZARD and each cause of the HAZARD to theRISK analysis and to the vERIFICATION that the RISK of the HAZARD is controlled
NOTE This document may be held on paper or on electronic media.
2.201.10
SAFETY
freedom from unacceptable RISK
2.201 .1 1
SAFETY HAZARD (hereinafter referred to as HAZARD )
potentially detrimental effect on the PATIENT , other persons, animals, or the surroundings,arising directly from MEDICAL ELECTRICAL EQUIPMENT
2.201 .1 2
Not used.
2.201 .1 3
SEVERITY
qualitative measure of the possible consequences of a HAZARD.IEC 60601-1-4 pdf download.