YY/T 1474-2016 in English

VALID

Medical devices－Application of risk management to medical devices

Issued on:2016-01-26
Implemented on:2017-01-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $1,200.00
$1,164.00

Standard No:	YY/T 1474-2016
Document status:	VALID
Title in English:	Medical devices－Application of risk management to medical devices
Title in Chinese:	医疗器械可用性工程对医疗器械的应用
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2016-01-26
Implemented on:	2017-01-01
ICS Classification:	11.040-Medical equipment
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	medical devices medical devices scopethis annex medical devices－application medical device medical device industry
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本标准规定了有关医疗器械可用性的分析、确定、设计、验证和确认过程。
本标准适用于评定医疗器械可用性问题引起的风险。

Scope

This annex is an introductory guide to the application of the usability engineering process necessary to achieve user interface design requirements during the development of medical devices (including hardware, software, and documentation). This annex is derived from ANSI 200111. This annex is not intended to be the sole source of usability engineering guidance or a substitute for expert advice on usability engineering, but rather to provide the reader with a general understanding of how to conduct usability engineering work in an effective manner. This annex makes extensive references to relevant documents (see References). This annex includes: an overview of usability engineering (human factors engineering), a discussion of the benefits of usability engineering, a review of the usability engineering process, and related analysis and design techniques. This annex also contains a list of applicable documents and usability engineering references. For this annex, the user interface includes all aspects of the medical device with which the user interacts during operation. Accompanying documentation and other medical device markings are part of the user interface. Users to be considered include maintenance personnel, cleaning personnel, and other service personnel who operate the medical device. Users may be caregivers (e.g., people using a home dialysis machine), patients (e.g., diabetics who measure their own glucose levels), or people who provide support to caregivers or patients (e.g., ultrasound technicians). Caregivers may be trained clinicians or lay persons (e.g., family members). This annex describes the needs of different categories of professionals who plan, finance, manage, research, design, and test activities related to the safety and usability of medical devices, including:
　——company, department, project, and product managers;
　——design and engineering professionals (e.g., usability engineers, industrial designers, technical writers, information designers, software developers, mechanical engineers, electrical engineers, packaging engineers);
　——medical researchers and other interested clinicians; and — marketing and other business professionals in the medical device industry. It should be noted that the practice of usability engineering is widely varied. This diversity is due in part to the diversity of its participants, who may have backgrounds in fields such as engineering, psychology, or design. Practices also vary due to the wide variety and complexity of medical devices, which range from digital thermometers to imaging systems and may be used by a wide variety of professionals and laypeople in hospitals, clinics, homes, and other settings. Therefore, it is impossible to prescribe a single set of usability engineering methods that is optimal for all design options. Instead, this standard describes usability engineering processes that require additional reengineering and scoping to suit the specific participants, experience, research and design philosophies, and project specifications. The ultimate goal of this standard is to ensure that manufacturers approach user interface design in a rigorous and effective manner.

More samples: DL/T 368-2010 GB 50021-2001(2009) QC/T 942-2021

Sample only — not a preview of YY/T 1474-2016

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