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

Scope

This standard specifies that for medical devices that require cleaning before disinfection and/or sterilization, the manufacturer shall provide processing information to ensure that the medical device is safe and effective for its intended use. This information includes the processing of medical devices before their first or reuse.
This standard does not define the definition of processing instructions, but rather specifies the requirements for medical device manufacturers to provide detailed processing instructions, which 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 standard applies to interventional or other medical devices that directly or indirectly contact patients.
This standard does not apply to the processing of the following items:
——Low-risk medical devices that are not expected to directly contact patients;
——Textiles used for patient bedding or surgical gowns;
——Single-use medical devices that the manufacturer specifies can be used directly.

Development Information

Replace the following standards

Superseded by the following standards

Referenced Standards

Adopt standards

Related Standards