IEC 60601-1-4:2002 pdf download

IEC 60601-1-4:2002 pdf download.Medical electrical equipment -Part 1-4:
General requirements for safety -Collateral Standard: Programmable electrical medical systems.
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.
2.20 1.1
DEVELOPMENT LIFE-CYCLE
necessary activities occurring during a period of time that starts at the concept phase of a project and finishes when the VALIDATION of the PEMS is complete
2.20 1.2
HAZARD ANALYSIS
identification of HAZARDS and their initiating causes
NOTE The quantification of HAZARD is not a part of the HAZARD ANALYSIS.
2.20 1.3
MAXIMUM TOLERABLE RISK
value of RISK which is specified as the maximum which may be permitted
NOTE The value may be specilied for the PENS as a whole or for a particular HAZARD.
2.20 1.4
PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS)
MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM containing one or more
PROGRAMMABLE ELECTRONIC SUBSYSTEM
2.20 1.5
PROGRAMMABLE ELECTRONIC SUBSYSTEM (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 the harm
2.201 .15
VERIFICATION
process of evaluating a PEMS or a component of a PEMS to determine whether the products of a given development phase satisfy the specified requirements imposed at the start of that phase
2.202 Degrees of requirements and miscellaneous terms
In this Collateral Standard, certain terms (which are not printed in small capitals) have particular meanings, as follows:
– “shall” indicates a requirement that is mandatory for compliance;
“should” indicates a strong recommendation that is not mandatory for compliance:
“may” indicates a permitted manner of complying with a requirement or of avoiding the need to comply;
– “specific” is used to indicate definitive information stated in this Collateral Standard or referenced in other standards, usually concerning particular operating conditions, test arrangements or values connected with compliance;
– “specified” is used to indicate definitive information stated by the MANUFACTURER in ACCOMPANYING DOCUMENTS or in other documentation relating to the PEMS under consideration, usually concerning its intended purposes, or the parameters or conditions associated with its use or with testing to determine compliance.
6 Identification, marking and documents
6.8 ACCOMPANYING DOCUMENTS
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 shall be placed in both the INSTRUCTIONS FOR USE and the RISK MANAGEMENT FILE.
6.8.202 ACCOMPANYING DOCUMENTS for the PEMs shall identify， as a minimum，theMANUFACTURER and a unique identifier such as revision level and date of release/issue.
NOTEInformation 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 iNSTRUCTIONSFOR USE so that it is available to the usER independently of the software operation.
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTs
52Abnormal operation and fault conditions
52.201 Documentation
52.201.1 Documents produced from application of this standard shall be maintained andshall form part of the quality records; see figure 201.This should be done in accordance with6.3 of lso 9oo0-3.
52.201.2 These documents，herein referred to as the RISK MANAGEMENT FILE, shall beapproved,issued and changed in accordance with a formal configuration managementsystem. This should be done in accordance with 6.2 of lso 9000-3.
52.201.3 A RISK MANAGEMENT SUMMARY shall be developed throughout the DEVELOPMENT LIFE-cYCLE as part of the RISK MANAGEMENT FILE. lt shall contain:
a) identified HAZARDS and their initiating causes;
b) estimation of RISK;
c) reference to the SAFETY measures, used to eliminate or control the RIsK of the HAZARD;d) evaluation of effectiveness of RIsK control;
e) reference to VERIFICATION.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.