YY/T 0802-2020 Processing of medical devices - Information to be provided by the medical device manufacturer
1 Scope
This document 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.
This standard are 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
YY/T 0316 Medical devices - Application of risk management to medical devices (YY/T 0316-2016, ISO 14971: 2007, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
[GB/T 19971-2015, Definition 2.7]
Note: Cleaning is for the safe processing of medical devices and/or the next processing. Cleaning agents and water are often used to remove contaminants (such as blood, protein and other debris) attached to the surface, crevices, serrations, joints and lumen of medical devices by a manual or automated process.
3.2
disinfecting agent
physical or chemical agent that is able to reduce the number of viable microorganisms
3.3
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose
3.4
manual cleaning
removal of contaminants from an item to the extent necessary for further processing or for intended use without the use of an automated process
3.5
manufacturer
natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)
[YY/T 0287-2017, Definition 3.10]
Note: Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition of manufacturer.
3.6
packaging system
combination of the sterile barrier system and protective packaging
[GB/T 19971-2015, Definition 2.28]
3.7
processing
activity to prepare a new or used healthcare product for its intended use
Note: For the purposes of this document, processing includes cleaning, disinfection and/or sterilization.
3.8
processor
organization and/or individual with the responsibility for carrying out actions necessary to prepare a new or reusable healthcare product for its intended use
3.9
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use
[GB/T 19971-2015, Definition 2.37]
3.10
reusable medical device
medical device designated or intended by the manufacturer as suitable for processing and reuse
3.11
service life
number of processing cycles and/or life-time that a medical device can be subjected to and remain suitable and safe for its intended use
3.12
single-use medical device
medical device designated or intended by the manufacturer for one-time use only
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Validation of the processes identified in the information
5 Risk analysis
6 Information to be provided by the medical device manufacturer
7 Presentation of the information
Annex A (Informative) Commonly used processing methods
Annex B (Informative) Example of processing instructions for reusable medical devices
Annex C (Informative) Classification of medical device
Annex D (Informative) Additional guidance on information to be provided by the medical device manufacturer
Bibliography
YY/T 0802-2020 Processing of medical devices - Information to be provided by the medical device manufacturer
1 Scope
This document 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.
This standard are 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
YY/T 0316 Medical devices - Application of risk management to medical devices (YY/T 0316-2016, ISO 14971: 2007, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
[GB/T 19971-2015, Definition 2.7]
Note: Cleaning is for the safe processing of medical devices and/or the next processing. Cleaning agents and water are often used to remove contaminants (such as blood, protein and other debris) attached to the surface, crevices, serrations, joints and lumen of medical devices by a manual or automated process.
3.2
disinfecting agent
physical or chemical agent that is able to reduce the number of viable microorganisms
3.3
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose
3.4
manual cleaning
removal of contaminants from an item to the extent necessary for further processing or for intended use without the use of an automated process
3.5
manufacturer
natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)
[YY/T 0287-2017, Definition 3.10]
Note: Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition of manufacturer.
3.6
packaging system
combination of the sterile barrier system and protective packaging
[GB/T 19971-2015, Definition 2.28]
3.7
processing
activity to prepare a new or used healthcare product for its intended use
Note: For the purposes of this document, processing includes cleaning, disinfection and/or sterilization.
3.8
processor
organization and/or individual with the responsibility for carrying out actions necessary to prepare a new or reusable healthcare product for its intended use
3.9
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use
[GB/T 19971-2015, Definition 2.37]
3.10
reusable medical device
medical device designated or intended by the manufacturer as suitable for processing and reuse
3.11
service life
number of processing cycles and/or life-time that a medical device can be subjected to and remain suitable and safe for its intended use
3.12
single-use medical device
medical device designated or intended by the manufacturer for one-time use only
Contents of YY/T 0802-2020
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Validation of the processes identified in the information
5 Risk analysis
6 Information to be provided by the medical device manufacturer
7 Presentation of the information
Annex A (Informative) Commonly used processing methods
Annex B (Informative) Example of processing instructions for reusable medical devices
Annex C (Informative) Classification of medical device
Annex D (Informative) Additional guidance on information to be provided by the medical device manufacturer
Bibliography
