YY 9706.111-2021Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (English PDF)
医用电气设备 第1-11部分：基本安全和基本性能的通用要求 并列标准：在家庭护理环境中使用的医用电气设备和医用电气系统的要求
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 9, 2021
Implementation date
May 1, 2023
Scope
YY 9706.111-2021 is the English-translated version of 医用电气设备 第1-11部分：基本安全和基本性能的通用要求 并列标准：在家庭护理环境中使用的医用电气设备和医用电气系统的要求.
YY 9706.111 is the collateral standard for medical electrical equipment used at home.
The home is not a hospital: the mains supply is less reliable and less well earthed, there is no biomedical engineering department, children and pets are present, the device may be dropped or used in a bathroom, and the operator is a patient or a relative rather than a trained clinician.
This standard adds the requirements that follow from that, covering mechanical robustness, ingress protection, electrical safety under domestic supply conditions, usability and the instructions a lay user actually needs.
Home care is expanding rapidly in China with ventilators, oxygen concentrators and monitors moving out of hospitals. Being a YY standard without the /T suffix, compliance is compulsory. It took effect in May 2023.
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Document preview — YY 9706.111-2021
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword3
- 1 Scope, object and related standards5
- 2 Normative references6
- 3 Terms and definitions7
- 4 General requirements9
- 5 * General requirements for testing ME EQUIPMENT15
- 6 * Classification of ME EQUIPMENT and ME SYSTEMS16
- 7 ME EQUIPMENT identification, marking and documents17
- 8 Protection against excessive temperatures and other hazards24
- 9 Accuracy of controls and instruments and protection against hazardous outputs27
- 10 Construction of ME EQUIPMENT28
- 11 * Protection against strangulation or asphyxiation33
- 12 Additional requirements for electromagnetic emissions of ME EQUIPMENT and33
- ME SYSTEMS34
- 13 Additional requirements for alarm systems of ME EQUIPMENT and ME34
- SYSTEMS34
- Appendix A (informative) General guidance and rationale36
- Appendix B (informative) Guide to marking and labelling requirements for ME36
- EQUIPMENT and ME SYSTEMS64
- Appendix C (informative) Symbols on marking68
- References70
Foreword
All technical contents (requirements) in this part are mandatory.
The series of standards, Medical electrical equipment, include two parts.
-- Part 1: General and collateral requirements;
-- Part 2: Particular requirements.
This part is Part 1-11.
This part was drafted in accordance with the rules given in GB/T 1.1-2009.
This part was redrafted and modified in relation to IEC 60601-1-11.2015 Medical
electrical equipment - Part 1-11.General requirements for basic safety and essential
performance - Collateral Standard. Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment.
The technical differences between this part and IEC 60601-1-11.2015 and their reasons are as follows.
-- Regarding normative references, adjustments with technical differences were
made in this part to adapt to Chinese technical conditions. The adjustments are
reflected in Chapter 2 "Normative references". The specific adjustments are as follows.
CISPR 11.2009 is replaced with GB 4824, which is identical to the
international standard;
IEC 60601-1.2005+AMD1.2012 is replaced with GB 9706.1, which is
modified in relation to the international standard;
1 Scope, object and related standards
This part specifies the requirements for the basic safety and essential performance of
medical electrical equipment and medical electrical systems (hereinafter referred to as
ME EQUIPMENT and ME SYSTEMS) for use in the home healthcare environment.
This part applies to ME EQUIPMENT and ME SYSTEMS intended for use in the home
healthcare environment, as specified by the manufacturer in the instructions for use.
This part applies regardless of whether the ME EQUIPMENT or ME SYSTEM is
intended for use by a lay operator or by trained healthcare personnel.
The home healthcare environment includes.
-- the dwelling place in which a patient lives;
-- other places where patients are present both indoors and outdoors, excluding
professional healthcare facility environments where operators with medical
training are continually available when patients are present.
This part does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for
use in the emergency medical services environment, covered by YY 9706.112 or solely
for use in professional healthcare facilities covered by GB 9706.1 without the additions
of YY 9706.112 or this part. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be
intended for multiple use environments, and as such, if also intended for use in the home
healthcare environment, are within the scope of this standard.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements
- 5 * General requirements for testing ME EQUIPMENT
- 6 * Classification of ME EQUIPMENT and ME SYSTEMS
- 7 ME EQUIPMENT identification, marking and documents
- 8 Protection against excessive temperatures and other hazards
- 9 Accuracy of controls and instruments and protection against hazardous outputs
- 10 Construction of ME EQUIPMENT
- 11 * Protection against strangulation or asphyxiation
- 12 Additional requirements for electromagnetic emissions of ME EQUIPMENT and
- 13 Additional requirements for alarm systems of ME EQUIPMENT and ME
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 74 pages — is available in the English PDF.
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