AS IEC 60601.1.6:2017 – Medical electrical equipment Part 1.6: General requirements for basic safety and essential performance—- Collateral standard: Usability.
A.1 General guidance
This annex provides a concise rationale for the important requirements of this collateral standard. Its purpose is to promote effective application of the collateral standard by explaining the reasons for the requirements and provide additional guidance where appropriate.
A.2 Rationale for particular clauses and subclauses
The following are rationales for specific clauses and subclauses in this collateral standard, with clause and subclause numbers parallel to those in the body of the document
Subclause 1.1 — Scope
This collateral standard focuses on the UsABILITY of the OPERATOR-EQUIPMENT INTERFACE of
ME EQUIPMENT. USABIUTY. In general. Includes attributes such as OPERATOR satisfaction and
EFFICIENCY. These attributes might be related to the BASIC SAFETY or ESSENTIAL PERFORMANCE
of the ME EQUIPMENT. A degradation of these attributes can lnctease the probability of USE
ERROR. Examples of attributes that are not Considered could include the aesthetics of the
ME EQUIPMENT or the amount of supplies consumed.
DefinItion 3.1 — OPERATOR-EQUIPMENT INTERFACE
The OPERATOR-EQUIPMENT INTERFACE includes all means of communication between the ME EQUIPMENT to the OPERATOR and the OPERATOR to the ME EQUIPMENT. These means include, but are not limited to:
— markings and ACCOMPANYING DOCUMENTS:
— lights;
— video displays:
— push buttons:
— touch screens:
— auditory and visual INFORMATION SIGNALS:
— ALARM SIGNALS:
— vibratory signals:
— keyboard and mouse: and
— haptic controls.
Subclause 4.1 — Conditions for application to ME EQUIPMENT
This collateral standard specifies requirements addressing particular RISKS associated with USABILITY. When these requirements are complied with, the RESIDUAL RISKS associated with USABILITY are presumed to be acceptable unless there is OBJECTIVE EVIDENCE to the contrary.
This follows from 4.2 of the general standard, which states Where thIs standard or any of its collateral or particular standards specify verifiable requirements addressing particular RISKS. and these requirements are complied with, the RESIDUAL RISKS addressed by these requirements shall be presumed to be acceptable unless there is OBJECTIVE EVIDENCE to the conlrary.
The criteria for judging RISK acceptability are established by the USABILITY VALIDATION plan, which specifies the criteria for determining successful VALIDATION of the USABILITY of the PRIMARY OPERATING FUNCTIONS.
Subclause 4.2 — USABILITY ENGINEERING PROCESS for ME EQUIPMENT
The first edition of this collateral standard was published In 2004. and Introduced a USABILITY ENGINEERING PROCESS tailored to ME EQUIPMENT. The second edition was published In 2006 and was intended to align the collateral standard with the third edition of IEC 60601-I — principally the Inclusion in IEC 60601-1:2005 of the requirement to conduct a RISK MANAGEMENT PROCESS following ISO 14971. The USABILITY ENGINEERING PROCESS described in the second edition of IEC 60801-1-6 was little altered from that In the first edition.
Shortly after the publication of the 2004 edition of IEC 60601-1-6. IEC SubcommIttee 62A formed a joint project with ISO Technical Committee 210 to develop a general USABILITY ENGINEERING PROCESS standard applicable to all MEDICAL DEVICES as defined In the ISO quality system standard. ISO 13485:2003. This project was similar in scope to the effort that took the RISK MANAGEMENT PROCESS described Ifl IEC 60601-1-4 and generalized it to produce ISO 14971. The result of the joint IECISC 62A — ISOITC 210 USABILITY standard project was IEC 62366:2007.
While the USABILITY ENGINEERING PROCESS described in IEC 62366 is more mature and refined than the PROCESS in the second edition of IEC 60601-1.6. it is fundamentally the same
PROCESS.
The scope of IEC 60601-1 and of this collateral standard is confined to performing a TYPE TEST of ME EQUIPMENT: it does not extend to life-cycle monitoring. For this reason, the monitoring of production and post-production information and the planning thereof, as required by the ISO 14971 framework, is excluded from the USABILITY ENGINEERING PROCESS described in this standard. The requirement in IEC 62366 for periodic maintenance of the USABILITY ENGINEERING PROCESS is also excluded.
As with the RISK MANAGEMENT PROCESS before it, the existence of a generalized standard for USABILITY ENGINEERING eliminates the need for much, but not all, of the content in the second edition of ICC 60601-1-6, For example, ICC 62366 defines the USER as the person using, i.e. operating or handling, the MEDICAL DEVICE, This definition includes those who clean, maintain or install the MEDICAL DEVICE. In ICC 60601-1:2005+A1:2012, persons performing those functions are described as SERVICE PERSONNEL, This subclause bridges between the general PROCESS requirement in IEC 62366 and the specific application to ME EQUIPMENT.