YY/T 1474-2016Medical devices - Application of usability engineering to medical devices (English PDF)

Foreword

This Standard was drafted as per the rules specified in GB/T 1.1-2009.

This Standard used the translation method to equivalently adopt IEC 62366:2007 Medical Devices - Application of Usability Engineering to Medical Devices. Terms are shown in bold in this Standard.

The clauses and articles with an asterisk (*) in this Standard have explanations on their reasons in Annex A.

Please note some contents of this Document may involve patents. The issuing agency of this Document does not assume the responsibility to identify these patents.

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.

YY/T 0316-2016 Medical Devices - Application of Risk Management to Medical Devices (ISO 14971:2007 revised edition, IDT)

3 Terms and Definitions

For the purpose of this document, the terms and definitions given in YY/T 0316-2016 and the following apply.

4 Principles

If the USABILITY ENGINEERING PROCESS detailed in this Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then, for the purposes of ISO 14971, the RESIDUAL RISKS associated with USABILITY of the MEDICAL DEVICE shall be presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.

5 Usability Engineering Process

An identification of characteristics related to SAFETY (part of a RISK ANALYSIS) that focuses on USABILITY shall be performed according to YY/T 0316-2016, 4.2.

During the identification characteristics related to SAFETY, the following shall be considered.

6 Accompanying Document

If provided, the ACCOMPANYING DOCUMENT shall include a summary of the MEDICAL DEVICE application specification (see 5.1).

7 Training and Materials for Training

If training on the specific MEDICAL DEVICE is required for the safe and effective use of a PRIMARY OPERATING FUNCTION by the intended USER, the MANUFACTURER shall do at least one of the following.

Annex A (Informative)

General Guidance and Rationale This annex provides a rationale for this Standard. Its purpose is to promote effective application of the standard by explaining the reasons for the requirements and definitions and to provide additional guidance where appropriate.