YY/T 0802.1-2024: Processing of medical devive - Information to be provided by the medical device manufacturer - Part 1: Critical and semi-critical medical devices

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Scope

This document specifies the requirements for information to be provided by medical
device manufacturers regarding the processing of critical and semi-critical medical
devices (i.e., medical devices that enter normally sterile areas of the human body, or
medical devices that contact mucous membranes or non-intact skin) or medical devices
that are to be sterilized.
This document applies to information on the processing prior to the use or reuse of
medical devices.
This document does not define processing instructions, but rather specifies
requirements for medical device manufacturers to provide detailed processing
instructions that include the following applicable steps.
a) immediate on-site processing after use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) Transportation.
This document does not apply to the processing of the following items.
-- Non-critical medical devices that are not intended to be sterilized;
A documented procedure for obtaining, recording and interpreting the results necessary
to determine that a process consistently produces product conforming to predetermined
specifications.
3.20 verification
To confirm by providing objective evidence that specified requirements have been met.
[Source. ISO 9000.2015, 3.8.13, modified]
3.21 washer-disinfectors; WD
Equipment that is expected to clean and disinfect items.
[Source. ISO 11139.2018, 3.319, modified]

Basic Data

Standard ID	YY/T 0802.1-2024 (YY/T0802.1-2024)
Description (Translated English)	Processing of medical devive - Information to be provided by the medical device manufacturer - Part 1: Critical and semi-critical medical devices
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	26,278
Date of Issue	2024-09-29
Date of Implementation	2025-10-15
Older Standard (superseded by this standard)	YY/T 0802-2020
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements for medical device manufacturers to provide information on the handling of medium- and high-risk medical devices (i.e. medical devices that enter the normal sterile parts of the human body, or medical devices that contact mucous membranes or incomplete skin) or medical devices prepared for sterilization. This standard applies to information on the handling of medical devices before use or reuse. This standard does not define handling instructions, but specifies requirements to assist medical device manufacturers in providing detailed handling instructions.