可用性设计101:形成性评价与总结性评价5/101

目的与时间：

形成性评价/FORMATIVE EVALUATION

时间上形成性评价的实施覆盖了整个研发周期，在设计前期识别用户接口设计的长处与不足，在设计后期实施形成性评价评估设计是否满足安全性，可用性，等各项需求并支持总结性评价。

A FORMATIVE EVALUATION seeks to evaluate USER INTERFACE designs during their development (i.e. during their “formation”) rather than when they are considered complete.

At an early stage of USER INTERFACE design, FORMATIVE EVALUATION serves to identify design strengths and opportunities for improvement. At the latter stage of USER INTERFACE design , FORMATIVE EVALUATION enables the MANUFACTURER to determine whether the MEDICAL DEVICE meets SAFETY , USABILITY , USER and business needs and ultimately supports successful SUMMATIVE.

总结性评价/SUMMATIVE EVALUATION

总结性评价一般在设计几乎完成后实施，来评估医疗器械与潜在的由使用错误引起的风险是否闭合。总结性评价一般在数个形成性评价之后进行。

The purpose of a SUMMATIVE EVALUATION is to evaluate the USABILITY of the USER INTERFACE as it relates to the successful completion of the TASKS associated with the HAZARD - RELATED USE SCENARIOS .These results are then transferred to the RISK MANAGEMENT PROCESS to determine whether the RESIDUAL RISK is acceptable.

A SUMMATIVE EVALUATION usually follows one or more FORMATIVE EVALUATIONS . A successful SUMMATIVE EVALUATION demonstrates that a MEDICAL DEVICE is not vulnerable to potentially harmful USE ERRORS .

形式：

形成性评价/FORMATIVE EVALUATION

a) various types of reviews, such as

– expert reviews     专家评审

– standards reviews  标准评审

– heuristic analyses  启发式分析

b) cognitive walkthroughs   认知演练

c) USABILITY TESTS 可用性测试

总结性评价/SUMMATIVE EVALUATION

-可用性测试

S UMMATIVE EVALUATION generally involves performing a USABILITY TEST under conditions of simulated use.

参考标准：IEC TR 62366-2