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YY/T 0802-2020 English PDF (YY/T0802-2020)

YY/T 0802-2020 English PDF (YY/T0802-2020)

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YY/T 0802-2020: Processing of medical devices - Information to be provided by the medical device manufacturer

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Scope

This Standard specifies requirements for the information to be provided by the
medical device manufacturer for the processing of a medical device that
requires cleaning followed by disinfection and/or sterilization to ensure that the
device is safe and effective for its intended use. This includes information for
processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document
specifies requirements to assist manufacturers of medical devices in providing
detailed processing instructions that consist of the following activities, where
applicable.
a) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
The Standard is applicable to medical devices that are intended for invasive or
other direct or indirect patient contact.
This Standard excludes processing of the following.
- non-critical medical devices not intended for direct patient contact;
- textile devices used in patient draping systems or surgical clothing;
- medical devices specified by the manufacturer for single-use only and
supplied ready for use.

Basic Data

Standard ID YY/T 0802-2020 (YY/T0802-2020)
Description (Translated English) Processing of medical devices - Information to be provided by the medical device manufacturer
Sector / Industry Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C47
Classification of International Standard 11.080.01
Word Count Estimation 22,257
Date of Issue 2020-06-30
Date of Implementation 2021-12-01
Issuing agency(ies) State Drug Administration


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