YY 9706.111-2021: 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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Scope

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.

Basic Data

Standard ID	YY 9706.111-2021 (YY9706.111-2021)
Description (Translated English)	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
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C30
Word Count Estimation	45,413
Issuing agency(ies)	State Drug Administration