YY/T 0802-2020 English PDF (YYT0802-2020)

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YY/T 0802-2020: Processing of medical devices -- Information to be provided by the medical device manufacturer
YY/T 0802-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
Replacing YY/T 0802-2010
Processing of medical devices - Information to be
provided by the medical device manufacturer
(ISO 17664:2017, Processing of health care products -
Information to be provided by the medical device manufacturer for the
processing of medical devices, MOD)
ISSUED ON: JUNE 30, 2020
IMPLEMENTED ON: DECEMBER 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
Introduction ... 5 
1 Scope ... 7 
2 Normative references ... 8 
3 Terms and definitions ... 8 
4 Validation of the processes identified in the information ... 12 
5 Risk analysis ... 12 
6 Information to be provided by the medical device manufacturer ... 13 
7 Presentation of the information ... 22 
Annex A (Informative) Commonly utilized processing methods ... 23 
Annex B (Informative) Example of processing instructions for reusable medical
devices ... 28 
Annex C (Informative) Classification of medical devices ... 30 
Annex D (Informative) Additional guidance on information to be provided by the
medical device manufacturer ... 33 
Bibliography ... 34 
Foreword
This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY/T 0802-2010 "Sterilization of medical devices -
Information to be provided by the manufacturer for the processing of
resterilizable medical devices". Compared with YY/T 0802-2010, in addition to
editorial changes, the main technical changes are as follows:
- Modify the title of the standard. The medical devices processed include not
only resterilizable medical devices, but also single-use medical devices that
are supplied non-sterile;
- ADD introduction and normative references;
- ADD some terms (see 3.2, 3.6, 3.9~3.12, 3.14, 3.15, 3.17, 3.18);
- Modify some terms and definitions (see 3.4 and 3.21; 2.4 and 2.13 of the
2010 edition);
- Modify the structure and order of clauses (see Clause 4~Clause 7; Clause
3~Clause 6 of the 2010 edition);
- Modify cleaning and disinfection; distinguish between automated and
manual situations (see 6.6 and 6.7; 3.5 and 3.6 of the 2010 edition);
- ADD transportation requirements (see 6.13);
- ADD Annex C and Annex D.
This Standard uses the redraft law to modify ISO 17664:2017 "Processing of
health care products - Information to be provided by the medical device
manufacturer for the processing of medical devices".
The technical differences between this Standard and ISO 17664:2017 and their
reasons are as follows:
- Replace ISO 14971 with the identical YY/T 0316;
- Delete the term 3.6 medical device in ISO 17664:2017. The definition of
this term is inconsistent with China's medical device regulations.
- In 6.6.2 and 6.7.2, use "a washer-disinfector meeting the requirements of
the relevant product standard" instead of "a washer-disinfector meeting the
requirements of the ISO 15883 series". The various parts of the ISO 15883
series have not been completely transformed into China's standards. And
there are product standards for washer-disinfectors that are different from
ISO 15883, such as GB 30689-2014, GB/T 35267-2017, etc.
This Standard also makes the following editorial changes:
- Delete the foreword of ISO 17664:2017;
- Replace the international documents of bibliography of ISO 17664:2017
with applicable China's documents;
- Take the paragraph after Table B.1 of ISO 17664:2017 as the last column
of the table.
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority of this document shall
not be held responsible for identifying any or all such patent rights.
This Standard was proposed by National Medical Products Administration.
This Standard shall be under the jurisdiction of National Technical Committee
200 on Sterilization Techniques and Equipments of Standardization
Administration of China (SAC/TC 200).
Drafting organizations of this Standard: Guangdong Medical Devices Quality
Surveillance and Test Institute, Peking Union Medical College Hospital,
Shinva Medical Instrument Co., Ltd., Beijing Maidi Jincheng Medical Supplies
Co., Ltd.
Main drafters of this Standard: Hu Changming, Zhang Qing, Lin Manting, Lv
Liansheng, Wang Hongmin, Sun Mingqiang.
Processing of medical devices - Information to be
provided by the medical device manufacturer
1 Scope
This Standard 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.
The Standard is 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 documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are applicable to this document.
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  from an item to the extent necessary for further
processing or for intended use.
[GB/T 19971-2015, definition 2.7]
Note: Cleaning consists of the removal, usually with detergent and water, 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.
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