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YY/T 1495-2016Microbiological test method for demonstrating cleaning and disinfecting efficacy (English PDF)

清洗消毒效果的微生物验证方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 29, 2016

Implementation date

June 1, 2017

Scope

YY/T 1495-2016 is the English-translated version of 清洗消毒效果的微生物验证方法.

YY/T 1495-2016 is the Chinese pharmaceutical industry standard that gives the microbiological test method for demonstrating the cleaning and disinfecting efficacy of a washer-disinfector that disinfects with heat.

It sets out the test organisms and the soil in which they are carried, the inoculation of the test pieces, the run of the machine and the recovery and counting of the survivors.

It does not apply to chemical disinfection nor to objects that cannot be cleaned and disinfected by heat. Issued on 29 July 2016, it has applied since 1 June 2017.

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Document preview — YY/T 1495-2016

National Standard of the People's Republic of China

Classification: C 47

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 Test material
5 test supplies
7 Preparation of test contaminants
9 verify the cleaning effect of cleaning
10 Results
12 Biosecurity
Appendix A (informative) Media and reagents Reference

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies a microbiological test method for verifying the effect of cleaning and disinfection. And roundsys.s.s.s.s.s.s. ands.s.s. Finds.s.s. Finds.s.s. Finds.s.ithers.s.s. ands.s.

Equipment for heat and disinfection of the cleaning disinfection, does not apply to the use of chemical disinfection methods and disinfection of the object is not heat cleaning disinfection.

Note: YY/T 0734.1 and YY/T 0734.2 specify the requirements and methods for verifying the cleaning effect and disinfecting effect of the cleaning and sterilizer. This standard is provided An alternative method of microbiological verification, but not the only way to verify the effect of cleaning and disinfecting. Other standards provided by the method if confirmed valid, also with the same Applicable.

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 65 slotted cylindrical head screws

GB 8599 large steam sterilizer technical requirements automatic control type

YY/T 0646 small steam sterilizer automatic control type

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Standard strain

Genes that are identified and guaranteed and traceable by genetic traits provided by domestic or foreign species preservation agencies.

3.2 Standard stockpile stockingculturestrain/referencestocks

A culture obtained by resuscitation of standard strains and growth in a suitable medium.

3.3 Working strain

The culture obtained by passage of the standard stockpile.

3.4 Bacteria carrier carrier susceptercoveredbytestmicroorganism

Inoculated with the support of the test microorganisms.

4 Test materials

4.1 Bacterial carrier

--- stainless steel screws, specifications for the M6 × 20mm, should meet the requirements of GB/T 65;

--- rubber hose, diameter. (6 ± 1) mm, wall thickness. (2 ± 1) mm, no pyrogen, cold rolling.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB/T 38151-2019|GB/T 36004-2018

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