GB 27949-2020 PDF English
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General requirements of disinfectant of medical instruments
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| GB/T 27949-2011 | English | 160 |
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Hygienic requirements for medical items disinfection
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GB 27949-2020: PDF in English GB 27949-2020
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Replacing GB/T 27949-2011
General requirements for disinfectant of medical
instruments
ISSUED ON: APRIL 09, 2020
IMPLEMENTED ON: NOVEMBER 01, 2020
Issued by: State Administration of Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Raw material requirements ... 6
5 Technical requirements ... 6
6 Inspection methods ... 9
7 Method of use ... 10
8 Markings ... 11
9 Packaging, storage and transportation ... 11
General requirements for disinfectant of medical
instruments
1 Scope
This standard specifies the raw material requirements, technical requirements,
inspection methods, methods of use, identification, packaging, storage,
transportation requirements for the chemical disinfectant for the disinfection and
sterilization of medical instruments.
This standard applies to disinfectants for medical items.
This standard does not apply to sterilization equipment with sterilization factor
generators and gas or disinfection and sterilization products that play a role
after being vaporized under certain conditions.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 30689 Hygienic requirements for endoscope automatic cleaning and
disinfecting machine
GBZ 2 (All parts) Occupational exposure limits for harmful factors in the
workplace
WS 507 Technical specification for cleaning and disinfection of soft
endoscope
Technical specification for disinfection (2002 edition) [Ministry of Health
(WFJF [2002] No.282)]
Technical specification for inspection of disinfection effect of endoscope
cleaning and disinfecting machine (for trial) [Ministry of Health (WFJF [2003]
No.330)]
Pharmacopoeia of the people's Republic of China (2015 edition, four volume)
5.5.2 Requirements for simulated field test
5.5.2.1 Sterilizer
At the minimum action concentration specified in the instruction manual and the
dose of 50% of the shortest action time, if there is no growth of viable bacteria
[Bacillus subtilis black variant (ATCC9372) spores] on the simulated medical
item to be tested, it shall determine that the simulated field sterilization test of
the medical item is qualified.
5.5.2.2 High-level disinfectant
At the minimum action concentration specified in the instruction manual and the
dose of the shortest action time, if the killing or logarithmic value of the spores
of Bacillus subtilis black variant (ATCC9372) on the simulated medical item to
be tested is not less than 3.00, it shall determine that the simulated field
sterilization test of the medical item is qualified.
5.5.2.3 Intermediate-level disinfectant
At the minimum action concentration specified in the instruction manual and the
dose of the shortest action time, if the killing or logarithmic value of the
Mycobacterium (ATCC19977) on the simulated medical item to be tested is not
less than 3.00, it shall determine that the simulated field sterilization test of the
medical item is qualified.
5.5.2.4 Low-level disinfectant
Among the Staphylococcus aureus (ATCC6538), Pseudomonas aeruginosa
(ATCC15422), Candida albicans (ATCC10231), select the microorganism with
the strongest resistance to the tested disinfectant as the experimental
microorganism. At the minimum action concentration specified in the instruction
manual and the dose of the shortest action time, if the killing or extinction log-
value of the microorganisms tested on the simulated medical item shall not be
less than 3.00, it shall determine that the simulated field sterilization test of the
medical item is qualified.
5.6 Requirements for disinfectants used in conjunction with disinfection
instruments
The special purpose disinfectants used in conjunction with the relevant
disinfection and sterilization devices, such as disinfectants for endoscopes,
disinfectants for dialysis machine’s pipelines, etc., shall meet the requirements
of corresponding disinfection and sterilization devices such as WS507, GB
30689 as well as relevant national standards. It shall verify the simulated
disinfection and sterilization effects used in conjunction with related equipment.
It is determined according to the relevant test methods in the "Technical
specifications for disinfection" (2002 edition).
7 Method of use
7.1 General
7.1.1 Medical items are preferred to be handled by thermal disinfection and
sterilization.
7.1.2 The method of use shall comply with the standards and specifications of
various types of disinfectants.
7.1.3 Before disinfecting or sterilizing the newly launched medical items, it shall
first remove the oil stains and protective films; then use detergent to wash it to
remove the grease; dry it.
7.1.4 Before disinfection or sterilization of contaminated medical items after use,
they shall be fully cleaned and dried; the shaft joint shall be opened during
treatment to fully expose it to disinfectant.
7.1.5 The sterilant which needs to be diluted before use as well as the high and
intermediate level disinfectant shall be diluted by purified water, to avoid the
influence of calcium, magnesium and other impurities on the disinfection effect.
7.2 Soak disinfection
7.2.1 Immerse the medical item to be treated in the disinfectant to make it
completely submerged; then cover the disinfection container to let it action for
the specified time.
7.2.2 For high-critical and intermediate-critical medical items, after the
completion of disinfection and sterilization and before use, it shall use sterile
water to rinse it clean or use other methods to remove residual disinfectant.
7.2.3 After immersed sterilization, the medical item shall avoid secondary
contamination during the process of washing, transferring, storing. Among them,
high-critical medical items shall be stored aseptically after sterilization;
intermediate-critical medical items shall be clean-stored after sterilization or
high-level disinfection; low-critical medical items shall be clean-stored after low
and intermediate-level disinfection.
7.3 Wipe disinfection
7.3.1 According to the requirements of the disinfectant’s instruction manual,
after the medical item is wiped and disinfected, use appropriate methods to
remove residual disinfectant as appropriate.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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