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GB/T 27949-2011

Chinese Standard: 'GB/T 27949-2011'
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BASIC DATA
Standard ID GB/T 27949-2011 (GB/T27949-2011)
Description (Translated English) Hygienic requirements for medical items disinfection
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C59
Classification of International Standard 11.080
Word Count Estimation 8,836
Date of Issue 2011-12-30
Date of Implementation 2012-04-01
Quoted Standard GB/T 191
Drafting Organization Zhejiang Province Center for Disease Control
Administrative Organization Ministry of Health
Regulation (derived from) Announcement of Newly Approved National Standards No. 23 of 2011
Proposing organization People's Republic of China Ministry of Health
Issuing agency(ies) Ministry of Health of People's Republic of China; Standardization Administration of China
Summary This standard specifies the technical requirements for medical devices disinfectants, test methods, the use of methods, marking, labeling and instructions and precautions. This standard applies to medical device disinfection, sterilization disinfectant. This standard does not apply with disinfection factor generating device class or disinfection equipment and gas gasified under certain conditions play a role in disinfection, sterilization products.

GB/T 27949-2011
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 59
Hygienic requirements for medical items disinfection
医疗器械消毒剂卫生要求
ISSUED ON: DECEMBER 30, 2011
IMPLEMENTED ON: APRIL 01, 2012
Issued by: Ministry of Health of PRC;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 Technical requirements ... 6 
5 Test method ... 8 
6 Method of use ... 9 
7 Signs, labels and instruction manuals ... 9 
8 Precautions for use ... 9 
Hygienic requirements for medical items disinfection
1 Scope
This standard specifies the technical requirements, test methods, methods of
use, signs, labels, instructions, precautions for medical item disinfectants.
This standard applies to disinfectants for disinfection and sterilization of medical
items.
This standard does not apply to sterilization instruments and devices which are
equipped with sterilization factor generators or disinfection and sterilization
products that play a role after being vaporized under specific 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
Pharmacopoeia of the People's Republic of China
Technical specifications for disinfection, by Ministry of Health
Standards for the management of label instructions for disinfection products
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Medical items
Instruments, equipment, utensils, materials or other articles used alone or in
combination on the human body.
3.2
Critical items
3.9
Low-efficacy disinfectant
Disinfectant that can kill bacterial propagules and lipophilic viruses.
4 Technical requirements
4.1 Raw material requirements
4.1.1 The raw materials of the product shall comply with the relevant provisions
of the "Pharmacopoeia of the People's Republic of China", the corresponding
national or industry standards, etc.
4.1.2 The production water shall be purified water.
4.2 Disinfectant product requirements
4.2.1 Sensory traits
It shall conform to the unique smell of disinfectant and the color of the product,
without obvious precipitation.
4.2.2 Physical-chemical indicators
4.2.2.1 The content and pH value of the active ingredients of the product shall
meet the relevant standards of product quality.
4.2.2.2 Validity period
The validity period of the original packaged product shall be ≥ 12 months.
4.2.2.3 Continuous use stability
If the disinfectant needs to be used continuously, during use, the simulated field
sterilization or disinfection effect of medical items shall meet the corresponding
requirements.
4.2.2.4 Corrosion to metals and instruments
Disinfectant shall be non-corrosive to stainless steel at the dosage used, non-
corrosive to carbon steel, aluminum, copper and other metals or only mildly
corrosive; it has no obvious corrosiveness to the medical item and its
components in case of long-term use.
4.2.3 Index of killing microorganism
4.2.3.1 Sterilizer
6 Method of use
6.1 Immersion disinfection and sterilization of medical items
Before disinfection and sterilization of medical item, fully clean it; soak the
cleaned medical item in disinfectant to completely submerge it, to make it be
completely submerged. Then cover the disinfection container, to allow it to
action for a specified period of time. Disinfected or sterilized medical items are
rinsed by sterile distilled water before use.
6.2 Wiping disinfection of medical items
According to the requirements of the disinfectant’s instruction manual, after the
medical item to be treated is wiped and disinfected, it can be wiped by the use
of alcohol cotton balls or sterile deionized water to remove residual disinfectant.
7 Signs, labels and instruction manuals
It shall meet the relevant requirements such as GB/T 191, "Standards for the
management of label instructions for disinfection products".
8 Precautions for use
8.1 According to the performance of medical items, contaminated pathogens
the purpose of disinfection treatment, select the appropriate disinfectant.
8.2 The contaminated instruments shall be fully cleaned and dried before
disinfection or sterilization; the shaft joints shall be opened during the treatment
to fully expose them to disinfectant.
8.3 After the disinfection and sterilization of critical and semi-critical medical
items, they shall be rinsed by sterile water before use.
8.4 Disinfec......
Related standard:   GB 27949-2020  GB 27948-2020
Related PDF sample:   GB 27949-2020  GB 27948-2020
   
 
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