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YY/T 1474-2016 PDF English

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YY/T 1474-2016: Medical devices－Application of risk management to medical devices
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YY/T 1474-2016: Medical devices－Application of risk management to medical devices

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YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040 C 30 YY/T 1474-2016 / IEC 62366.2007 Medical Devices - Application of Usability Engineering to Medical Devices (IEC 62366.2007, IDT) Issued on. JANUARY 26, 2016 Implemented on. JANUARY 01, 2017 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 4 Introduction... 5 1* Scope... 6 2 Normative References... 6 3 Terms and Definitions... 6 4* Principles... 11 4.1 General requirements... 11 4.1.1* USABILITY ENGINEERING PROCESS... 11 4.1.2 RESIDUAL RISK... 12 4.1.3 Information for SAFETY... 12 4.2* USABILITY ENGINEERING FILE... 13 4.3 Scaling of the USABILITY ENGINEERING effort... 13 5* Usability Engineering Process... 14 5.1* Application specification... 14 5.2* Frequently used functions... 14 5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY... 15 5.3.1 Identification of characteristics related to SAFETY... 15 5.3.2* Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS... 15 5.4 PRIMARY OPERATING FUNCTIONS... 16 5.5* USABILITY SPECIFICATION... 17 5.6 USABILITY VALIDATION plan... 18 5.7* USER INTERFACE design and implementation... 19 5.8* USABILITY VERIFICATION... 19 5.9* USABILITY VALIDATION... 20 6* Accompanying Document... 21 7 * Training and Materials for Training... 21 Annex A (Informative) General Guidance and Rationale... 23 Annex B (Informative) Categories of USER Action... 39 Annex C (Informative) Examples of USE ERRORS, ABNORMAL USE and Possible Causes... 41 Annex D (Informative) Guidance on the USABILITY ENGINEERING PROCESS ... 45 Annex E (Informative) Questions that can be Used to Identify MEDICAL DEVICE Characteristics Associated with USABILITY that could Impact on SAFETY... 78 Annex F (Informative) Examples of Possible USABILITY Related HAZARDOUS SITUATIONS... 83 Annex G (Informative) USABILITY goals. Illustrative Example for a Home Parenteral Infusion Pump... 86 Annex H (Informative) Sample USABILITY SPECIFICATION and its Inputs. 98 Annex I (Informative) Recommended Reading List... 114 Annex J (Informative) Reference to the Essential Principles... 124 Bibliography... 125 Index of Defined Terms... 128

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. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of Management Centre of the Standards for Medical Devices, China Food and Drug Administration. Drafting organizations of this Standard. Beijing Hua Guang Certification of Medical Devices Co., Ltd.; and Shanghai Testing & Inspection Institute for Medical Devices. Chief drafting staffs of this Standard. Wang Huifang, Mi Lanying, He Jun, Lu E, Zheng Yihan, and Chen Zhigang. 1*Scope This Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.

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. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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