AS IEC 60601.1.6 pdf download – Medical electrical equipment Part 1.6: General requirements for basic safety and essential performance— Collateral standard: Usability
1 Scope, object and related standards
1.1 * Scope This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY , as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT , hereafter referred to as ME EQUIPMENT .
This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS , i.e., NORMAL USE . It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE .
If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS , as defined in ISO 1 4971 , associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1 .2 of IEC 62366:2007).
1.2 Object The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.
1 .3 Related standards
1 .3.1 IEC 60601 -1 For ME EQUIPMENT , this collateral standard complements IEC 60601 -1 . When referring to IEC 60601 -1 or to this collateral standard, either individually or in combination, the following conventions are used:
• “the general standard” designates IEC 60601 -1 alone (IEC 60601 -1 :2005+A1 :201 2);
• “this collateral standard” designates IEC 60601 -1 -6 alone (IEC 60601 -1 -6:201 0+A1 :201 3);
• “this standard” designates the combination of the general standard and this collateral standard.
1.3.2 Particular standards A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.
2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE The way in which these referenced documents are cited determines the extent (in whole or in part) towhich they apply.
IEC 60601-1:2005，Medical electrical equipment – Part 1: General requirements for basicsafety and essential performance
IEC 60601-1-8:2006,Medical electrical equipment – Part 1-8:General requirements for basicsafety and essential performance – Collateral standard: General requirements，tests andguidance for alarm systems in medical electrical equipment and medical electrical systemsAmendment 1:2012
IEC 62366:2007，Medical devices – Application of usability engineering to medical devicesAmendment 1:—2)
ISO 14971:2007,Medical devices – Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005+A1:2012，IEC 60601-1-8:2006+A1:2012，IEC 62366:2007+A1:—2) and the followingdefinitions apply.
NOTE An index of defined terms used with this collateral standard is found beginning on page 27.3.1
means by which the OPERATOR and the ME EQUIPMENT communicate[ANSI/AAMI HE 74:2001, definition 3.24 modified]
NOTEThe AcCOMPANYING DOCUMENTs are considered part of the ME EQUIPMENT and the oPERATOR-EQUIPMENTINTERFACE.
summary of the mental, physical and demographic traits of the intended oPERATOR population,as well as any special characteristics that can have a bearing on design decisions,’such asoccupational skills and job requirements
4.1 * Conditions for application to ME EQUIPMENT
The ME EQUIPMENT shall provide adequate USABILITY such that the RISKs resulting from NORMALusE and uSE ERROR are acceptable.See also 7.1.1 and 12.2 of the general standard.
Compliance with this subclause is considered to exist when compliance with 4.2 and otherclauses and subclauses of this collateral standard is demonstrated.