YY/T 0506.7-2014 English PDF (YYT0506.7-2014)

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YY/T 0506.7-2014: Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 7: Test methods for determination of cleanliness-mircrobial
YY/T 0506.7-2014
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.14
C 46
Surgical drapes, gowns and clean air suits for
patients, clinical staff and equipment - Part 7. Test
methods for determination of cleanliness-microbial
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 01, 2015
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Principle ... 5
5 Instruments and reagents ... 6
6 Test methods ... 6
7 Method description ... 10
8 Test report ... 10
Foreword
YY/T 0506 “Surgical drapes, gowns and clean air suits for patients, clinical staff
and equipment” consists of the following parts.
- Part 1. General requirements for manufacturers, processors and products;
- Part 2. Performance requirements and performance levels;
- Part 3. Test methods;
- Part 4. Test method for linting in the dry state;
- Part 5. Test method for resistance to dry microbial penetration;
- Part 6. Test method to determine the resistance to wet bacterial penetration;
- Part 7. Test methods for determination of cleanliness-microbial.
This Part is Part 7 of YY/T 0506.
This Part is drafted in accordance with the rules given in GB/T1.1-2009.
This Part shall be under the jurisdiction of Jinan Quality Supervision and
Inspection Center for Medical Devices of China Food and Drug Administration.
Main drafting organization of this Part. Shandong Quality Inspection Center for
Medical Devices.
Participating drafting organization of this Part. Winner Medical (Shenzhen) Co.,
Ltd.
Main drafters of this Part. Wang Wenqing, Zhang Buzeng, Hao Shubin, Song
Haibo, Zheng Duozing.
Surgical drapes, gowns and clean air suits for
patients, clinical staff and equipment - Part 7. Test
methods for determination of cleanliness-microbial
1 Scope
The method given in this Part of YY/T 0506 is applicable to the evaluation of
cleanliness-microbial of surgical drapes, gowns and clean air suits.
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.
GB/T 19973.1 Sterilization of medical devices - Microbiological methods -
Part 1. Determination of a population of microorganisms on products
YY/T 0506.1 Surgical drapes, gowns and clean air suits for patients, clinical
staff and equipment - Part 1. General requirements for manufacturers,
processors and products
YY/T 0506.2 Surgical drapes, gowns and clean air suits for patients, clinical
staff and equipment - Part 2. Performance requirements and performance
levels
YY/T 0506.3 Surgical drapes, gowns and clean air suits for patients, clinical
staff and equipment - Part 3. Test methods
3 Terms and definitions
For the purpose of this document, the terms and definitions defined in GB/T
19973.1, YY/T 0506.1, YY/T 0506.2 and YY/T 0506.3 apply.
4 Principle
SET the suitable elution procedure, USE the bag peristalsis method to elute the
1, No. 2 and No. 3 samples.
6.1.2 Sample elution
The 3 samples are separately placed into 3 sterile homogenized bags in an
aseptic manner. 200 mL of sodium chloride injection is added to each
homogenized bag, and each homogenized bag is placed in the homogenizer
separately. Set the elution parameters of the homogenizer. It is recommended
to set the elution parameters to such that the operating frequency is 200 r/min
and the operating duration is 1 min. The homogenizer is started and the
samples are eluted separately.
6.1.3 Transfer into the medium
The filter apparatus is placed on a clean workbench, and the filter membrane
and filter bowl are loaded onto the filter apparatus in an aseptic manner. Each
portion of eluate with a volume of 200 mL is filtered through two filter
membranes, 100 mL for each. The surface of the filter membrane with bacteria
is placed face up on a nutrient agar medium plate and a rose red sodium agar
medium plate, respectively.
6.1.4 Cultivation and counting
3 nutrient agar medium plates are placed in a constant temperature incubator
at 35 °C for 3 days, and 3 rose red sodium agar medium plates are placed in a
constant temperature incubator at 28 °C for 5 days. The colony growth is
observed every day, and the number of colonies is counted.
6.1.5 Calculation of results
The total number of colonies eluted form each sample is calculated according
to formula (1).
where.
Yi - the total number of colonies eluted from the ith sample, CFU;
Ai - the total number of colonies on the nutrient agar medium plate of the ith
sample, CFU;
Bi - the total number of colonies on the rose red sodium agar medium plate
of the ith sample, CFU.
i = 1, 2, 3.
The three plates affixed with filter membranes are placed in a constant
temperature incubator at 35 °C for 3 days. The colony growth is observed every
day, and the number of colonies is counted.
6.2.7 Calculation of results
The average number of colonies eluted from the 3 samples is calculated
according to formula (3).
where.
X - the average number of colonies eluted from the 3 samples, CFU;
Xa - the number of colonies eluted from sample a, CFU;
Xb - the number of colonies eluted from sample b, CFU;
Xc - the number of colonies eluted from sample c, CFU.
The recovery rate is calculated according to formula (4).
where.
R - the recovery rate;
X - the average number of colonies eluted from the 3 samples, CFU;
Z - the number of inoculated spores, CFU.
The correction factor is calculated according to formula (5).
where.
f - the correction factor;
R - the recovery rate.
6.3 Calculation of cleanliness-microbial
The calculation of cleanliness-microbial is performed according to formula (6).