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YY/T 1474-2016 English PDF (YYT1474-2016)

YY/T 1474-2016 English PDF (YYT1474-2016)

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

YY/T 1474-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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 and Inspection Institute for Medical Devices. Chief drafting staffs of this Standard: Wang Huifang, Mi Lanying, He Jun, Lu E, Zheng Yihan, and Chen Zhigang.
Medical Devices - Application of Usability Engineering
to Medical Devices
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.
NOTE: For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE.
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 the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2).
This Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.
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.
NOTE: Informative references are listed in the “Bibliography”.
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.

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