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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
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YY 9706.111-2021: PDF in English YY 9706.111-2021
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PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.040
C 30
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
(IEC 60601-1-11:2015, MOD)
ISSUED ON: MARCH 9, 2021
IMPLEMENTED ON: MAY 1, 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 ... 7
4 General requirements ... 9
5 * General requirements for testing ME EQUIPMENT ... 15
6 * Classification of ME EQUIPMENT and ME SYSTEMS ... 16
7 ME EQUIPMENT identification, marking and documents ... 17
8 Protection against excessive temperatures and other hazards ... 24
9 Accuracy of controls and instruments and protection against hazardous outputs . 27
10 Construction of ME EQUIPMENT ... 28
11 * Protection against strangulation or asphyxiation ... 33
12 Additional requirements for electromagnetic emissions of ME EQUIPMENT and
ME SYSTEMS ... 34
13 Additional requirements for alarm systems of ME EQUIPMENT and ME
SYSTEMS ... 34
Appendix A (informative) General guidance and rationale ... 36
Appendix B (informative) Guide to marking and labelling requirements for ME
EQUIPMENT and ME SYSTEMS ... 64
Appendix C (informative) Symbols on marking ... 68
References ... 70
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;
IEC 60601-1-2:2014 is replaced with YY 9706.102, which is modified in
relation to the international standard;
IEC 60601-1-6:2010+AMD1:2013 is replaced with YY/T 9706.106, which
is modified in relation to the international standard;
IEC 60601-1-8:2006+AMD1:2012 is replaced with YY 9706.108-2021,
which is modified in relation to the international standard;
IEC 60601-1-12:2014 is replaced with YY 9706.112, which is modified in
relation to the international standard;
-- The 8-year education specified in IEC 60601-1-11:2015 is modified into the
Chinese 9-year compulsory education (see 7.1);
-- The requirement "if indication marks for the control of ME EQUIPMENT are
explained in text, they shall be in Chinese" is Added (see 7.1).
The following editorial changes are made to this part:
-- A.3 is added to Appendix A to provide the corresponding relationship between
international standards and current Chinese national standards or industry
standards;
-- The index is deleted.
Please note that some content in this document may be subject to patents. The publisher
of this document assumes no responsibility for identifying these patents.
This part was proposed by the National Medical Products Administration.
This part is under the jurisdiction of the National Technical Committee on Electrical
Equipment in Medical Practice of Standardization Administration of China
(SAC/TC10).
This part was drafted by: Shanghai Testing & Inspection Institute for Medical Devices,
BMC Medical Co., Ltd.
The main drafters of this part: He Jun, Chen Bei, Chen Xingwen, Hou Bingying, Gu
Zhengyu.
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
1 Scope, object and related standards
1.1 * Scope
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.
EXAMPLE: ME EQUIPMENT or ME SYSTEMS intended for both the home healthcare environment
and the professional healthcare facility environment.
NOTE 1: ME EQUIPMENT and ME SYSTEMS used in home healthcare environments can frequently
be used in locations with unreliable electrical sources and poor electrical grounding.
NOTE: See also YY 9706.108-2021.
Compliance is checked by inspection of the instructions for use.
7.4.7 * Additional requirements for cleaning, disinfection and sterilization
In addition to the requirements of 7.9.2.12 and 16.2 c), indent 3 of the general standard,
for ME EQUIPMENT, ME SYSTEMS, their parts or accessories that are intended for
other than single use and that can become contaminated through contact with the patient
or with body fluids or expired gases during intended use, the instructions for use shall:
-- indicate the frequency of cleaning, cleaning and disinfection or cleaning and
sterilization, as appropriate, of the ME EQUIPMENT, ME SYSTEMS, parts or
accessories used on the same patient including methods for rinsing, drying,
handling and storage between uses (see 8.1 and 8.2); and
EXAMPLE 1: Periodic cleaning and disinfection of a breathing system to prevent infection of
a patient during chronic care.
-- if intended for multiple patient use, indicate that it is necessary to clean and
disinfect or clean and sterilize the ME EQUIPMENT, ME SYSTEMS, parts or
accessories between uses on different patients, including methods for rinsing,
drying, handling and storage until re-use (see 8.1 and 8.2);
EXAMPLE 2: Cleaning and disinfection of a thermometer following use to prevent patient
cross infection.
-- indicate that the ME EQUIPMENT, ME SYSTEMS or accessories require
professional hygienic maintenance prior to re-use and provide contact details
for the source of these services (see 7.5.2).
Compliance is checked by inspection of the instructions for use.
7.4.8 Additional requirements for maintenance
In addition to the requirements of 7.9.2.13 of the general standard, the instructions for
use shall include:
-- the expected service life of the ME EQUIPMENT;
-- the expected service life of parts or accessories shipped with the ME
EQUIPMENT; and
-- where the shelf life is less than the expected service life, the shelf life of parts or
accessories shipped with the ME EQUIPMENT.
Compliance is checked by inspection of the instructions for use.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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