YY/T 0802-2020Processing of medical devices—Information to be provided by the medical device manufacturer (English PDF)
医疗器械的处理 医疗器械制造商提供的信息
This is a limited preview
Buy now to download the full PDF (19 pages)
Need quotation for your management?
Get a formal quotation for YY/T 0802-2020 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 30, 2020
Implementation date
December 1, 2021
Scope
YY/T 0802-2020 is the English-translated version of 医疗器械的处理 医疗器械制造商提供的信息.
YY/T 0802-2020 is the Chinese standard "Processing of medical devices—Information to be provided by the medical device manufacturer".
Its scope clause reads: 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. Its clauses include terms and definitions.
Found what you need?
Document preview — YY/T 0802-2020
National Standard of the People's Republic of China
- Replacing
- YY/T 0802-2010
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 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
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 […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Cited by
- YY/T 1966-2025Dentistry - Filling instrument with contra angle
- YY/T 1972-2025Dentistry - Tissue punches
- YY/T 1974-2025Dentistry - Multifunction handpieces
- YY/T 1976-2025Traditional Chinese medical device - Glass cupping device
- YY/T 1978-2025Dentistry - Trephine burs
- YY/T 1979-2025Traditional Chinese medical device - Gua Sha instruments
Similar standards
Editions of YY/T 0802
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0802-2020 | Processing of medical devices—Information to be provided by the medical device manufacturer | current edition | Current |
| YY/T 0802-2010 | Processing of medical devices—Information to be provided by the medical device manufacturer | previous edition | Superseded |
This page sells the current edition, YY/T 0802-2020. Earlier editions are listed for reference only.
How to Download YY/T 0802-2020
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY/T 0802.1-2024 — Processing of medical devive - Information to be provided by the medical device manufacturer - Part 1: Critical and semi-critical medical devices
YY/T 0802.2-2024 — Processing of medical device - Information to be provided by the medical device manufacturer - Part 2: Non-critical medical devices
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
Secure payment via Stripe
Payments accepted
YY/T 0802-2020
$330.00