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YY/T 0734.5-2020Washer-disinfectors - Part 5: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices (English PDF)

清洗消毒器 第5部分:对不耐高温的非介入式医疗器械进行化学消毒的清洗消毒器 要求和试验

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 21, 2020

Implementation date

January 1, 2021

Scope

YY/T 0734.5-2020 is the English-translated version of 清洗消毒器 第5部分:对不耐高温的非介入式医疗器械进行化学消毒的清洗消毒器 要求和试验.

YY/T 0734.5-2020 is the Chinese standard "Washer-disinfectors - Part 5: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices".

Its scope clause reads: This part of YY/T 0734 stipulates the special cleaning and sterilizer for chemical disinfection of non-intrusive medical devices that are not resistant to high temperatures Requirements and test methods.

Note. These medical devices are usually low-risk medical devices, such as hospital beds, operating tables, wheelchairs, etc. The requirements of this part are combined with the general requirements specified in YY/T 0734.1-2018.

The washer-disinfector required in this part is suitable for non-interventional, high temperature resistant reusable medical devices, which can be cleaned in a cycle Special requirements for cleaning and disinfection of cleaning and chemical disinfection, including performance requirements for cleaning and disinfection, as well as possible use of components and accessories Requirements.

The requirements of this part do not apply to the definitions in the scope of YY/T 0734.2, YY/T 0734.3, YY/T 0734.4 and GB/T 35267 Clean the sterilizer. Its clauses include terms and definitions.

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Document preview — YY/T 0734.5-2020

National Standard of the People's Republic of China

ICS
11.080.10
Classification
C 47

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

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions

1 Scope

This part of YY/T 0734 stipulates the special cleaning and sterilizer for chemical disinfection of non-intrusive medical devices that are not resistant to high temperatures

Requirements and test methods.

Note. These medical devices are usually low-risk medical devices, such as hospital beds, operating tables, wheelchairs, etc.

The requirements of this part are combined with the general requirements specified in YY/T 0734.1-2018.

The washer-disinfector required in this part is suitable for non-interventional, high temperature resistant reusable medical devices, which can be cleaned in a cycle

Special requirements for cleaning and disinfection of cleaning and chemical disinfection, including performance requirements for cleaning and disinfection, as well as possible use of components and accessories

Requirements.

The requirements of this part do not apply to the definitions in the scope of YY/T 0734.2, YY/T 0734.3, YY/T 0734.4 and GB/T 35267

Clean the sterilizer.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article

Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.

GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Part 1. General Requirements (GB 4793.1-2007, (IEC 61010-1..2001, IDT)

GB/T 18268.1 Requirements for electromagnetic compatibility of electrical equipment for measurement, control, and laboratory use. Part 1. General requirements (GB/T 18268.1-2010, IEC 61326-1..2005, IDT)

GB/T.19973.1 Sterile microbiological methods for medical devices Part 1. Determination of the total number of microorganisms on products (GB/T.19973.1-2015, ISO 11737-1..2006, IDT)

GB/T 35267 Endoscope washer-disinfector (GB/T 35267-2017, ISO 15883-4..2008, NEQ)

YY/T 0734.1-2018 Washer-disinfector part 1. General requirements and tests (ISO 15883-1..2006 AMD1.

2014, MOD)

YY/T 0734.4 Cleaning and sterilizing device Part 4. The cleaning and sterilizing device for non-intrusive medical equipment such as moist heat disinfection

Summation test (YY/T 0734.4-2016, ISO 15883-6..2011, NEQ)

3 Terms and definitions

The terms and definitions defined in YY/T 0734.1-2018, YY/T 0734.4 and GB/T 35267 and the following apply to this document.

3.1 Chemical disinfection

Disinfection achieved through the action of one or more disinfectants.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

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