YY/T 1737-2020 PDF English
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Overview:-- Overview:
YY/T 1737-2020 "Analytical method for bioburden control level of medical device" is a Chinese industry standard issued on September 27, 2020. This standard will be mandatorily enforced for new products, from September 01, 2021, for bioburden control level of medical device.
-- Standard and product transition:
This is the 1st standard in the evolution. There is no previous version.
-- Scope:
This Standard stipulates the analytical method for bioburden control level of medical device. This Standard applies to the analysis of bioburden control levels of sterile and implantable medical devices. This Standard is not applicable to the analyses performed to validate bioburden test values for products during the development phase.
-- Risks associated with the sterilization method of the product:
If the product is sterilized by overkill, from the perspective of sterilization, as long as the bioburden of the product does not exceed the spore count on the biological indicator (BI) for sterilization and the resistance does not exceed the D value of the BI, it can be effectively killed.
-- Risks related to the nature of contact between the product and the human body:
Products that come into contact with the human body can be divided into three main categories: surface contact device, external access device and implantable device. Among them, surface contact device is divided as per: skin contact, mucosal contact and damaged surface contact; external access device is divided as per: indirect blood contact, tissue/bone/dentin contact, circulating blood contact; implantable device is divided as per: tissue/bone contact and blood contact.
-- Monitoring frequency:
Sampling and bioburden testing can be performed at regular intervals or according to production frequency. The selection of bioburden monitoring frequency may take into account factors such as product material characteristics, production process characteristics, production frequency, seasonal and environmental changes, and sterilization methods.YY/T 1737-2020: Analytical method for bioburden control level of medical device---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1737-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.080.01
С 47
Analytical method for bioburden control level of medical
device
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: SEPTEMBER 01, 2021
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 6
4 Factors affecting product bioburden... 8
5 Risk of product bioburden... 8
6 Bioburden monitoring... 9
7 Correction treatment... 11
8 Change assessment... 11
9 Regular review... 11
Appendix A (Informative) Examples of statistical methods for alert level and acting
level... 12
Appendix B (Informative) Examples of establishing alert level and acting level without
historical data... 18
Bibliography... 19
1 Scope
This Standard stipulates the analytical method for bioburden control level of medical
device.
This Standard applies to the analysis of bioburden control levels of sterile and
implantable medical devices.
This Standard is not applicable to the analyses performed to validate bioburden test
values for products during the development phase.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
document.
GB/T 19971, Sterilization of health care products - Vocabulary
GB/T 19973.1, Sterilization of health care products - Microbiological methods -
Part 1.Determination of a population of microorganisms on products
YY/T 0287, Medical devices - Quality management systems - Requirements for
regulatory purposes
YY/T 0316, Medical devices - Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions, as well as those
given in GB/T 19971, apply.
3.1
colony forming unit; CFU
The microbial colony formed by the reproduction of one or several microorganisms
after microbial culture, abbreviated as CFU, and usually expressed in number.
3.2
correction factor
Used to compensate for data that cannot be fully collected from product and/or
microbial culture.
3.3
alert level
The microbial content level set by the user for products that require microbial control.
When the test results exceed this level, a monitoring program shall be initiated to track
the microbial contamination of the product.
3.4
acting level
The microbial content level set by the user for products that require microbial control.
When the test results exceed this level, an investigation procedure shall be initiated to
investigate the microbial contamination of the product.
4 Factors affecting product bioburden
There are many factors that affect the product bioburden. The risk sources that affect
bioburden as identified in YY/T 0316 include but are not limited to the following
aspects.
-- personnel clothing, personal hygiene, and personal habits;
-- equipment and work surfaces;
-- raw materials, packaging materials, components;
-- cleaning, assembly, packaging, handling and other operation methods.
5 Risk of product bioburden
5.1 Risks associated with the sterilization method of the product
5.1.1 If the product is sterilized by overkill, from the perspective of sterilization, as long
as the bioburden of the product does not exceed the spore count on the biological
indicator (BI) for sterilization and the resistance does not exceed the D value of the BI,
it can be effectively killed.
5.1.2 When a combined bioburden and biological indicator sterilization method is used,
the bioburden shall not exceed the predetermined limit and the resistance shall not
exceed the D value of the BI.
5.2 Risks related to the nature of contact between the product and the human body
5.2.1 Products that come into contact with the human body can be divided into three
main categories. surface contact device, external access device and implantable device.
Among them, surface contact device is divided as per. skin contact, mucosal contact
and damaged surface contact; external access device is divided as per. indirect blood
contact, tissue/bone/dentin contact, circulating blood contact; implantable device is
divided as per. tissue/bone contact and blood contact.
5.2.2 Medical devices of different contact categories have different bioburden
requirements. Low-risk devices, such as skin contact devices, have relatively low
bioburden requirements. High-risk devices, such as implantable devices that come into
contact with blood, have relatively high bioburden requirements. In addition, the impact
of endotoxins shall also be considered, and the product bioburden control level shall be
adjusted and controlled in combination with the endotoxin control level.
6 Bioburden monitoring
6.1 Documents
Manufacturers shall establish product bioburden monitoring documents.
6.2 Monitoring frequency
Sampling and bioburden testing can be performed at regular intervals or according to
production frequency. The selection of bioburden monitoring frequency may take into
account factors such as product material characteristics, production process
characteristics, production frequency, seasonal and environmental changes, and
sterilization methods.
6.3 Sampling
6.3.1 Select a representative product (or equivalent product) from the product family
for bioburden testing. If the product is not available (e.g., not produced during the
specified testing period), an acceptable alternative product (equivalent product) for the
product family shall be defined in the documentation to represent the normal production
process for testing.
6.3.2 Routine monitoring of bioburden levels typically uses 3 ~ 10 samples. The
production and treatment of samples shall be representative of normal production.
Note. Samples may be selected from products rejected due to other production quality
issues, provided that the rejected samples are representative of the regular
products and have no impact on the bioburden test results, and the samples are
initially packaged according to the regular production process for bioburden
testing.
6.4 Test
Follow relevant provisions of GB/T 19973.1.
6.5 Microbial culture (medium selection and culture conditions)
Follow relevant provisions of GB/T 19973.1.
6.6 Microbial identification
Microbiological identification should be considered during initial validation and when
the bioburden exceeds the acting level and/or the alert level. The identification of
microorganisms in bioburden shall first consider the identification of genus and species,
and shall be carried out in accordance with the relevant provisions of GB/T 19973.1.
6.7 Test report
6.7.1 The bioburden test report should include the following.
a) date of testing;
b) product description;
c) correction factor.
6.7.2 The final result of the bioburden test is the average of all the tested products in
the same batch (after introducing the correction factor for bioburden).
6.8 Analysis
6.8.1 Alert level and acting level should be specified for each product or product family.
Commonly used statistical methods include standard deviation method, percentile
method, probability chart method and control chart (range) method. Appendix A
provides examples of statistical methods for alert level and acting level.
6.8.2 Alert level and acting level should be based on historical data.
6.8.3 In the absence of historical data, Appendix B provides examples of establishing
alert level and acting level in the absence of historical data.
7 Correction treatment
7.1 When the monitoring result exceed the acting level, it is necessary to investigate the
cause, including laboratory investigation. If it is proven that there is no abnormality in
laboratory operations, further investigation including the production process will be
required. Where applicable, the investigation may include, but is not limited to, the
following.
a) process control of product sampling and transfer/transport to the laboratory;
b) any abnormal data;
c) changes in production process.
7.2 The situation where the acting level is exceeded should be handled in accordance
with corrective, preventive measures and/or non-conforming product control in YY/T
0287.
8 Change assessment
When a product is changed, the impact of the change on the product bioburden shall be
assessed and recorded.
9 Regular review
Product family, validation method and associated alert level and acting level shall be
regularly reviewed and recorded to ensure their continuing applicability. The review
may include.
a) assessment of the product family and representative product (or equivalent
product);
b) monitoring frequency;
c) test method validation/verification;
d) deviation events.
Appendix A
(Informative)
Examples of statistical methods for alert level and acting level
A.1 Standard deviation method
The standard deviation method has always been a traditional method for data analysis.
Table A.1 gives examples of using this method.
A.2 Percentile method
Percentile calculation is an alternative method for establishing alert level and acting
level. Percentile calculation makes no distributional assumptions about the underlying
data set and can be used for both normally and non-normally distributed data. It can be
used directly in most spreadsheet software programs (for example. the function
“Percentile.EXC” in EXCEL).
A.3 Probability graph method
A probability graph can be regarded as a graphical depiction of the percentile
calculation. The X-axis of the probability graph represents the original observation, and
the Y-axis represents its corresponding percentage. Traditionally, the probability graph
is used to check the normality of data, but it can also be used to establish the alert level
and the acting level using the 95th and 99th percentiles.
Figure A.1 – Probability graph obtained from the data in Table A.2
Calculations. The probability graph can be prepared manually using probability graph
paper or by computer using a statistical software program. Figure A.1 shows an example
of the probability graph. This graph is created using the data set in Table A.2.The alert
level and the acting level are established at the 95% and 99% points in the graph. In this
example, the alert level is approximately 94.1 CFU/device and the acting level is
approximately 112.7 CFU/device.
Advantages and disadvantages. In addition to being based on process data, probability
graph provides a graphical visualization of data, allowing the analyst to determine the
distribution of data. Probability graph can be found in most statistical software
programs. Probability graph has limitations in data analysis. When the data are clustered
at a few points, the probability graph should not be used.
A.4 Control chart (range) method
The use of drawing techniques offers several advantages in the analysis of monitoring
data. They are prepared either manually or using statistical software. Most charts are
individual value control charts that present time versus each test value. The test value
can be expressed in CFU/device. The control chart includes individual value, average
value, alert level and acting level. Graphs used for bioburden monitoring data differ
from conventional control charts in that the lower limit of the test value is fixed at zero,
and graphs used for bioburden monitoring data do not need to be specifically displayed.
Control chart uses process data to calculate the average value and control limits for the
process. Therefore, the values displayed on the control chart reflect the actual process
performance, and by viewing the data based on these values, analysts can easily identify
process variations that may require further investigation.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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