IEC 60601-1-4:2000 pdf free download – Medical electrical equipment
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 lnternational Standards.
This standard requires that a process with certain elements be established and followedbecause the subject technology is not amenable to pass/fail tests on the finished product.Theapproach is to state what is required, leaving the user of this Collateral Standard to determinehow this is achieved.This is similar to the approach taken in the lSO 9000 series.As usersare expected to be qualified,detail has been kept to a minimum. lteration of portions of theprocess is expected,but no requirements have been given because the need to repeatprocesses is unique to a particular project. lterations also arise from the more detailedunderstanding that emerges during the design process.
As part of the process, documentation is required because it is necessary for process control.ln addition，inspection of the documentation permits checking compliance with the processrequirements of this standard.A RISK MANAGEMENT SUMMARY is part of the documentation toassure that SAFETY issues and measures can be readily comprehended during and at the endof the process.
While not unique to PEMS，RISK management is emphasized in order to address the essentialcomplexity of the subject technology and to ensure the early identification of HAZARDS.Earlyidentification of HAZARDs is necessary if subsequent rigour is to be effective in addressingSAFETY.
The use of this Collateral Standard by qualified people is emphasized.This is done to keeprequirements to the essential elements and in recognition of the extensive and growingliterature in the fields of software assurance and HAZARD assessment techniques.Users ofthis Collateral Standard will need to employ the tools in this literature as specificcircumstances arise in the development of PEMs. In early phases, “top down” tools such asfault tree analysis will be in more frequent use. When the design is more detailed, “bottom up”tools such as failure modes and effects analysis will come into wider use.
The requirement to identify the PEMs is intended to ensure that usERs do not inadvertently usethe wrong software or an obsolete version of the software. Information on RESIDUAL RISK isincluded, because it may not be possible or practical to eliminate all HAZARDS. Where thisis the case， it is the MANUFACTURER’s minimum responsibility to make the usERs aware ofthose HAZARDs and provide information that may help avoid/mitigate them.