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

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.

lambda Replace IEC 60601-1:2005+AMD1.2012 with GB 9706.1-2020, which modifies and adopts the international standard;

lambda Replace ISO 14971:2007 with YY/T 0316, which is identical to the international standard;

lambda 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.

1 Scope, object and related standards

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. 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.

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)

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.

Summary of the mental, physical and demographic traits of the intended OPERATOR population, as well as any special characteristics that can have a bearing on design decisions, such as occupational skills and job requirements.

4 General requirements

A USABILITY ENGINEERING PROCESS complying with YY/T 1474-2016 shall be performed except. Compliance is checked by inspection of the USABILITY ENGINEERING FILE.

Evidence of compliance with this clause and all requirements of this standard referring to inspection of the USABILITY ENGINEERING FILE are satisfied if the MANUFACTURER has.

5 Replacement of requirements given in YY/T 1474-

In addition to requirements of YY/T 1474-2016 the following replacements shall apply.

Replace the first two paragraphs including Notes 1 and 2 of Clause 6 of YY/T 1474-2016 by.

Annex A (Informative)

General guidance and rationale This annex provides a concise rationale for the important requirements of this Part. Its purpose is to promote effective application of this Part by explaining the reasons for the requirements and provide additional guidance where appropriate.

Annex B (Informative)

Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007

Annex C (Informative)

References to items of USABILITY provided in IEC 62366:2007 and their use in other standards This annex is intended to provide references to specific items of USABILITY as given in IEC 62366:2007 as source in comparison to those used in other standards, such as the ISO 9241 series and standards on software. The indicated references are considered as guidance.