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YY/T 9706.106-2021 English PDF (YYT9706.106-2021)

YY/T 9706.106-2021 English PDF (YYT9706.106-2021)

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YY/T 9706.106-2021: Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -- Collateral Standard: Usability

YY/T 9706.106-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 30
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral Standard: Usability
(IEC 60601-1-6:2013, MOD)
ISSUED ON: MARCH 09, 2021
IMPLEMENTED ON: MAY 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope, object and related standards ... 5
2 Normative references ... 6
3 Terms and definitions ... 6
4 General requirements ... 7
5 * Replacement of requirements given in YY/T 1474-2016 ... 8
Annex A (Informative) General guidance and rationale ... 9
Annex B (Informative) Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007 ... 14
Annex C (Informative) References to items of USABILITY provided in IEC
62366:2007 and their use in other standards ... 15
Bibliography ... 18
Foreword
The "Medical electrical equipment" series of standards is divided into two parts: - Part 1: General and collateral requirements;
- Part 2: Particular requirements.
This Part is Part 1-6.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009. This Part uses the redraft law to modify and adopt IEC 60601-1-6:2013 "Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability".
The technical differences between this Part and IEC 60601-1-6:2013 and their reasons are as follows:
- As for the normative references, this Part has made adjustments with
technical differences, to adapt to the technical conditions of China. The adjustments are mainly reflected in Clause 2 “Normative references”. The specific adjustments are as follows:
 Replace IEC 60601-1:2005+AMD1:2012 with GB 9706.1-2020, which
modifies and adopts the international standard;
 Replace ISO 14971:2007 with YY/T 0316, which is identical to the
international standard;
 Replace IEC 60601-1-8:2006+AMD1:2012 with YY 9706.108, which
modifies and adopts the international standard.
This Part has made the following editorial changes:
- ADD A.3 to Annex A, which gives the correspondence between international standards and current Chinese national standards or industry standards; - Retain the title of Annex B; delete the specific content of Annex B.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority of this document shall not be held responsible for identifying any or all such patent rights.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Committee 10 on Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral Standard: Usability
1 Scope, object and related standards
1.1 * Scope
This Part specifies a PROCESS for a MANUFACTURER to analyse, specify,
design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY
and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT,
hereafter referred to as ME EQUIPMENT.
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.
If the USABILITY ENGINEERING PROCESS detailed in this Part has been
complied with and the acceptance criteria documented in the USABILITY
VALIDATION plan have been met (see 5.9 of YY/T 1474-2016), then the
RESIDUAL RISKS, as defined in YY/T 0316, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE
EVIDENCE to the contrary (see 4.1.2 of YY/T 1474-2016).
Note: Where an asterisk (*) is used as the first character of a title or the beginning of a paragraph or table title, it means that there is a related guidance or rationale in Annex A.
1.2 Object
The object of this Part is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. 1.3 Relationship with other standards
1.3.1 GB 9706.1
For ME EQUIPMENT, this Part complements GB 9706.1.
When referring to GB 9706.1 or to this Part, either individually or in combination, the following conventions are used:
- "the general standard" designates GB 9706.1-2020 alone;
- "this Part" designates YY/T 9706.106-2021 alone;
- "this standard" designates the combination of the general standard and this Part.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in this Part.
2 Normative references
The following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.
GB 9706.1-2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2012, MOD)
YY/T 0316 Medical devices - Application of risk management to medical
devices (YY/T 0316-2016, ISO 14971:2007 revised edition, IDT)
YY 9706.108 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (YY 9706.108-2021, IEC 60601-
1-8:2006+AMD1:2012, MOD)
YY/T 1474-2016 Medical devices - Application of risk management to
medical devices (IEC 62366:2007, IDT)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1-2020, YY 9706.108, YY/T 1474-2016 and the following definitions apply. 3.1
* Operator-equipment interface

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