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

Foreword

This document was drafted in accordance with the provisions of GB/T 1.1-2020

Directives for standardization - Part 1.Rules for the structure and drafting of

standardizing documents.

This document is part 1 of YY/T 0802 Processing of medical device - Information to be

provided by the medical device manufacturer. YY/T 0802 has been published in the

following parts.

-- Part 1.Critical and semi-critical medical devices;

-- Part 2.Non-critical medical devices.

This document replaces YY/T 0802-2020 Processing of medical devices - Information

to be provided by the medical device manufacturer. Compared with YY/T 0802-2020,

in addition to structural adjustments and editorial changes, the main technical changes

are as follows.

-- The scope has been changed (see Chapter 1; see Chapter 1 of the 2020 edition);

-- The term and definition of "medical device manufacturer" have been changed

(see 3.5; see 3.5 of the 2020 edition);

-- The content of the processing instructions has been changed (see 6.2; see 6.2 of

the 2020 edition);

-- The content of immediate on-site treatment after use has been changed (see 6.4;

see 6.4 of the 2020 edition);

This document is modified in relation to ISO 17664-1.2021 Processing of health care

products - Information to be provided by the medical device manufacturer for the

processing of medical devices - Part 1.Critical and semi-critical medical devices.

The technical differences between this document and ISO 17664-1.2021 and their

reasons are as follows.

-- The term and definition "3.5 medical device" have been deleted to coordinate

with regulations.

The following editorial changes were made to this document.

-- The note to the term and definition of "3.5 medical device manufacturer" has

been deleted.

Processing of medical device - Information to be provided by

the medical device manufacturer - Part 1.Critical and semi-

critical medical devices

1 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.

4 Validation of the processing in information

5 Risk analysis

Medical device manufacturers shall conduct risk analysis to determine the content and

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