YY/T 0802.1-2024 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 requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
This document is applicable to 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 excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— 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.
Note: See YY/T 0802.2-2024, Annex C, for further guidance on the application of medical device.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated reference, only the edition cited applies. For undated references, the latest edition of the referenced documents (including any amendments) applies.
GB/T 42062 Medical devices - Application of risk management to medical devices (GB/T 42062-2022, ISO 14971:2019, 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
Note: Cleaning is for the safe processing of medical devices and/or the next processing. Cleaning consists of the removal of adherent soil (e.g. blood, protein substances and other debris) from the surfaces, crevices, serrations, joints and lumens of a medical device by a manual or automated process that prepares the items for safe handling and/or further processing.
[Source: ISO 11139: 2018, 3.46, modified]
3.2
disinfecting agent
physical or chemical agent that is able to reduce the number of viable microorganisms
[Source: ISO 11139:2018, 3.83]
3.3
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose
[Source: ISO 11139:2018, 3.84]
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
[Source: ISO 11139:2018, 3.159]
3.5
medical device 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 their name, whether or not such a medical device is designed and/or manufactured by that person or on their behalf by another person(s)
[Source: ISO 11139: 2018, 3.167, modified]
3.6
packaging system
combination of the sterile barrier system and protective packaging
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.
[Source: ISO 11139: 2018, 3.214, modified]
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
[Source: ISO 11139: 2018, 3.216, modified]
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
[Source: ISO 11607-1: 2019, 3.14]
3.10
reusable medical device
medical device designated or intended by the manufacturer as suitable for processing and reuse
[Source: ISO 11139:2018, 3.236]
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
Note: A single-use medical device is not intended to be further processed and used again.
[Source: ISO 11139: 2018, 3.255, modified]
3.13
sterile
free from viable microorganisms
[Source: ISO 11139:2018, 3.271]
3.14
sterile barrier system
minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use
3.15
sterility assurance level; SAL
probability of a single viable microorganism occurring on an item after sterilization, expressed as the negative exponent to the base 10
3.16
sterilization
validated process used to render product free from viable microorganisms
Note: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival of a microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero.
3.17
sterilizing agent
physical or chemical entity, or combination of entities, having sufficient microbicidal activity to achieve sterility under defined conditions
3.18
terminal process
final step of processing to render a medical device safe and ready for its intended use
3.19
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
3.20
verification
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
[Source: ISO 9000: 2015, 3.8.13, modified]
Foreword II
Introduction IV
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 utilized processing methods
Annex B (Informative) Example of processing instructions for reusable medical devices
Annex C (Informative) Classification of medical devices
Annex D (Informative) Additional guidance on information to be provided by the medical device manufacturer
Bibliography
