Skip to product information
1 of 5

PayPal, credit cards. Download editable-PDF & invoice In 1 second!

GB/T 27949-2011 English PDF (GBT27949-2011)

GB/T 27949-2011 English PDF (GBT27949-2011)

Regular price $160.00 USD
Regular price Sale price $160.00 USD
Sale Sold out
Shipping calculated at checkout.
Quotation: 24-hr self-service. Click GB/T 27949-2011
See Chinese contents: GB/T 27949-2011

GB/T 27949-2011: Hygienic requirements for medical items disinfection

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.
GB/T 27949-2011
NATIONAL STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
ICS 11.080
C 59
Hygienic requirements for medical items disinfection
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 Disinfectants that are corrosive to metals and bleaching to fabrics shall be clearly indicated in the instruction manual; the corresponding precautions shall be noted.
8.5 The sterilization and high-and-middle-level disinfectants used after dilution shall be diluted by the use of sterile distilled water, to avoid the influence of calcium, magnesium and other impurities on the disinfection effect.
8.6 Do not mix with antagonistic substances.
8.7 It shall pay attention to ventilation and do personal safety protection work in the place of use.

View full details