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YY/T 0215-2016Ozone disinfector for medical purpose (English PDF)

医用臭氧消毒设备

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

June 1, 2017

Scope

YY/T 0215-2016 is the English-translated version of 医用臭氧消毒设备.

YY/T 0215-2016 is the Chinese pharmaceutical industry standard for the medical ozone disinfector, the equipment that disinfects with ozone gas or ozonated water.

It gives the terms and definitions, the specifications and classification, the requirements, the test methods, the marks and instructions and the rules for packaging, transport and storage, covering the ozone concentration produced and its accuracy, the disinfecting efficacy, the residual ozone and its destruction, the timer and the alarms, and the electrical safety. Issued on 29 July 2016, it has applied since 1 June 2017.

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Document preview — YY/T 0215-2016

National Standard of the People's Republic of China

Classification: C 47
Replacing: YY 0215-2008

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 normative reference document
3 Terms and definitions
4 specifications and classification
5 request
6 Test Method
7 logo, instruction manual
8 Packaging, transportation, storage

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0215-2008 "Medical Ozone Disinfection Cabinet".

This standard compared with YY 0215-2008, the main changes are as follows.

--- modified the standard name and scope of application;

--- increase the technical requirements of the ozone water equipment and electromagnetic compatibility requirements;

--- According to GB/T 14710 "medical electrical environment requirements and test methods" standard, modify the environmental test requirements;

- Appendix A and Appendix B were deleted.

1 Scope

This standard specifies the terminology and definitions, specifications and classification of medical ozone disinfection equipment, requirements, test methods, logos, instructions and Packaging, transportation, storage.

This standard applies to medical ozone disinfection equipment (hereinafter referred to as disinfection equipment). The disinfection equipment uses ozone gas or ozone water to resist Ozone-etched medical devices on the inner and/or outer surfaces of the medical device.

This standard does not apply to disinfection equipment (such as ultraviolet, chemical disinfectants, etc.) that may contain ozone other than ozone.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 191 packaging and storage icon

GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements General rules for the use of industrial products GB/T 9969 Environmental requirements and test methods for medical appliances GB/T

GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements

YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements Disinfection technical specifications (the People's Republic of China Ministry of Health.2002 edition)

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Ozone concentration

Disinfection equipment inside or output unit volume of gas or the amount of ozone contained in water, expressed in mg/m3 or mg/L.

3.2 Disinfection time

Disinfection equipment inside or the output of the ozone concentration maintained at the effective concentration of more than the duration.

3.3 No load empty-load

Disinfection equipment does not place the state of medical equipment.

3.4 Full load ful-load

Disinfection equipment according to the provisions of the manufacturer placed the maximum weight or volume of medical equipment status.

3.5 Amount of ozone leaked

Suspension equipment with full load or no load at rated voltage, maximum ozone in the air at 20 cm from its outer surface during the working cycle

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB 28232-2020|YY/T 1264-2015

Editions of YY/T 0215

Edition	Title	Revision	Status
YY/T 0215-2016	Ozone disinfector for medical purpose	current edition	Current
YY 0215-2008	Ozone disinfector for medical purpose	previous edition	Superseded

This page sells the current edition, YY/T 0215-2016. Earlier editions are listed for reference only.

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