BS EN 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices

BS EN 62366-1:2015 pdf free. Medical devices Part 1: Application of usability engineering to medical devices.
5 USABILITY ENGINEERING PROCESS
5.1 Prepare USE SPECIFICATION
The MANUFACTURER shall prepare a USE SPECIFICATION.
The USE SPECIFICATION shall include:
— intended medical indication;
NOTE I This can include conditions(s) or disease(s) to be screened, monitored. treated, diagnosed, or prevented
— intended PATIENT population:
NOTE 2 This can include age group, weight rang., health, or condition.
— intended part of the body or type of tissue applied to or interacted with:
— intended USER PROFILE;
— USE ENVIRONMENT: and
— • operating principle.
NOTE 3 The summary of th. IOICAI. DEVICE USE SPECIFICATION S referred to by some authorities having jurisdiction as the ‘statement of ntended use’
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.2 Identify USER INTERFACE characteristics related to SAFETY and potential USE
ERRORS
The MANUFACTURER shall identify USER INTERFACE characteristics that could be related to SAFETY as part of a RISK ANALYSIS performed according to ISO 14971:2007, 4.2. This identification may a’so be performed using the tools and techniques from the USABILITY ENGINEERING PROCESS. This identification shall include consideration of the PRIMARY OPERATING FUNCTIONS that are provided in applicable particular MEDICAL DEVICE SAFETY standards.
NOTE I ISO 14971:2007, C,2.29 to C234 provides a list of questions that can be used to identify USER INTERFACE characteristics that could impact SAFETY. The list of questions is not exhaustive.
Based on the identified USER INTERFACE characteristics and USE SPECIFICATION, the
MANUFACTURER shall identify the USE ERRORS that could occur and are related to the USER
INTERFACE. This identification may be accomplished by conducting a TASK analysis.
(27J(28J(29J
NOTE 2 TASK analysis is described in IEC 62366-2.
The results of this identification of characteristics related to SAFETY shall be stored in the
USABILITY ENGINEERING FILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.3 Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS
The MANUFACTURER shall identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS, which could affect PATIENTS. USERS or others, related to use of the MEDICAL DEVICE. This identification shall be conducted as part of a RISK ANALYSIS performed according to ISO 14971:2007, 4.3 and the first paragraph of ISO 14971 :2007, 4.4.
NOTE 1 Annex B contains examples of possible HAZARDS and HAZARDOUS SITUATIONS related to USABILITY.
During the identification of HAZARDS and HAZARDOUS SITUATIONS, the following shall be considered:
— USE SPECIFICATION, including USER PROFILE(S) (see 5.1);
— information on HAZARDS and HAZARDOUS SITUATIONS known for existing USER INTERFACES of MEDICAL DEVICES of a similar type, if available: and
— identified USE ERRORS (see 5.2).
The results of this identification of HAZARDS and HAZARDOUS SITUATIONS shall be stored in the USABILITY ENGINEERING FILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.4 Identify and describe HAZARD-RELATED USE SCENARIOS
The MANUFACTURER shall identify and describe the reasonably foreseeable HAZARD-RELATED USE SCENARIOS associated with the identified HAZARDS and HAZARDOUS SITUATIONS. The description of each identified HAZARD-RELATED USE SCENARIO shall include all TASKS and their sequences as well as the SEVERITY of the associated HARM.
NOTE Annex B contains examples of specifying sequences of USER actions that could resull In HAZARDS being
exposed to USERS.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.5 • Select the HAZARD-RELATED USE SCENARIOS for SUMUATIVE EVALUATION
The MANUFACTURER shall select the HAZARD-RELATED USE SCENARIOS to be included in the SUMMATIVE EVALUATION.
The MANUFACTURER shall select either:
— all HAZARD-RELATED USE SCENARIOS; or
— the subset of the HAZARD-RELATED USE SCENARIOS based on the SEVERITY of the potential HARM that could be caused by USE ERROR (e.g. for which medical intervention would be needed).
The choice of the scheme used to select the HAZARD-RELATED USE SCENARIOS may additionally depend on other circumstances specific to the MEDICAL DEVICE and the MANUFACTURER.
NOTE Examples of selection schemes are given in Annex A. 5.5, and IEC 62366.2.
A summary of any selection scheme, the rationale for its use and the results of applying it shall be stored in the USABILITY ENGINEERING FILE.
Compliance is chocked by inspection of the USABILITY ENGINEERING FILE.
5.6 * Establish USER INTERFACE SPECIFICATION
The MANUFACTURER shall establish and maintain a USER INTERFACE SPECIFICATION.
The USER INTERFACE SPECIFICATION shall consider:
— the USE SPECIFICATION (see 5.1);
— the known or foreseeable USE ERRORS associated with the MEDICAL DEVICE (see 5.2); and
— the HAZARD-RELATED USE SCENARIOS (see 5.4).
The USER INTERFACE SPECIFICATION shall include:
— testable technical requirements relevant to the USER INTERFACE, including the requirements for those parts of the USER INTERFACE associated with the selected RISK CONTROL measures;
NOTE Technical requirements for the USER iNTERFACE can include display colour, character size, or placement of
the controls,
— an indication as to whether ACCOMPANYING DOCUMENTATION is required: and
— an indication as to whether MEDICAL DEVICE-specific training is required.
The USER INTERFACE SPECIFICATION shall be stored in the USABILITY ENGINEERING FILE. The USER INTERFACE SPECIFICATION may be integrated into other specifications.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.
5.7 • Establish USER INTERFACE EVALUATION plan
5.7.1 General
The MANUFACTURER shall establish and maintain a USER INTERFACE EVALUATION plan for the USER INTERFACE SPECIFICATION.
The USER INTERFACE EVALUATION plan shall
a) document the objective and identify the method of any planned FORMATIVE EVALUATIONS and SUMMATIVE EVALUATIONS;
NOTE I Examples of FORMATIVE EVAI.uArION and SUMMATIVE EVALUATION methods are given in IEC 62366-2.
b) if USABILITY TESTS are employed.
— document the involvement of the representative intended USERS and USER PROFILE to
which they belong.
EXAMPLE 1 In a FORMATIVE EVALUATION, Clinical personnel from the MANUFACTURER are used for a nurse-
USER GROUP.
EXAMPLE 2 In a SUMUATIVE EVALUATION, a panel of practicing intensive care nurses are used for a critical
care nursing USER PROFILE.
Multiple USER PROFILES may be combined into a USER GROUP for the purposes of a
USABILITY TEST;
— document the test environment and other conditions of use, based on the USE
SPECIFICATION;
NOTE 2 These are the specific conditions of use which could affect the USERS TASKS performance.
EXAMPLE 3 Conditions of use could include location-specific conditions such as lighting, noise and
activIty levels.
EXAMPLE 4 Conditions of use could include personnel-specific conditions such as use of the MEDICAL
DEVICE while wearing personal protective equipment (•g. surgical gloves and safety goggles)
EXAMPLE 5 Conditions of use could include social conditions such as stress levels and working In teams.
— specify whether ACCOMPANYING DOCUMENTATION is provided during the test:
— specify whether MEDICAL DEVICE-specIfic training is provided prior to the test and the minimum elapsed time between the training and the beginning of the test.
USER INTERFACE EVALUATION methods may be quantitative or qualitative. USER INTERFACE EVAt.UATION may be performed in a variety of locations, such as. in a laboratory setting. in a simulated USE ENVIRONMENT or in the actual USE ENVIRONMENT.
NOTE 3 See 43 for scaling of the USASILITY ENGINEERING effort.
The USER INTERFACE EVALUATION plan may be integrated into other plans.
The USER INTERFACE EVALUATION plan shall be stored in the USABILITY ENGINEERING FILE.
Compliance is checked by inspection of the USABILITY ENGINEERING FILE.BS EN 62366-1 pdf free download.