GB/T 19973.2-2005 in English

ABOLISHED

Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process

Issued on:2005-11-04
Implemented on:2006-04-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	GB/T 19973.2-2005
Document status:	ABOLISHED
Superseded on:	2019-04-01
Title in English:	Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process
Title in Chinese:	医用器材的灭菌微生物学方法第二部分：确认灭菌过程的无菌试验
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2005-11-04
Implemented on:	2006-04-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	GB-National Standard
Related Keywords:	sterility test sterility tests sterilization process sterilization process scope1.1 medical devices
Related Topics:	sterile Box Sterilization Method Box Sterilization Program Contaminated microorganisms Sterility confirmation Aseptic packaging confirmation Microbial Sterilization aseptic process Biology Triple Confirmation Box + Sterilization + Method Sterilization in situ Sterilizer Sterility test Microbial Sterilization Sterility evaluation sterile english Sterility test Sterilization methods in the laboratory Sterility evaluation self-quenching process GB/T19973.2-2005 Quenching process Medical sterile jar Sterilization Confirmation of Sterile Medical Devices microbial matter GB/T 19973.2-2018 Microbial sterilizer Microbial Sterilization Methods filter sterilized Microorganism type Methods of Sterilization of Microorganisms collagen sterilization or sterilization Methods of Laboratory Sterilization biological sterilization method Microbial Sterilization Methods Microbial Disinfection and Sterilization Methods of Microbial Sterilization How to confirm the special process Methods of Biological Sterilization Sterilization and Filtration Non-sterile product medical devices GB19973.2 GBT19973.2 GB/T 19973.2-2005 GB/T 19973.2-2018 Sterilization tolerance How to use edible mushroom sterilizing pot Plant leaf sterilization method USP Sterility Analytical Method Validation Soil sterilization pot sterilization steps Microbial sterilization temperature and time Centrifuge sterilization method Microbiology experiments without sterile water Commonly used sterilization methods for fermentation tanks Sterile instrument industry Common sterilization methods for surgical instruments and accessories Sterility testing process international Commonly used bacteriostatic and sterilizing methods Sterility testing method for sterile cotton swabs Sterile water preparation methods and processes Sterilization method of ultra-clean clothes Autoclave sterilization method Sterilization methods for applicators Methods for reviving microbial strains Abscisic acid sterilization method High temperature sterilization test Medical sterile filtration Sterilization and bandaging method for wide-mouth bottles Add bacteria after microbial limit methodology Determination method of sterility degree of clean room Medical sterile biological laboratory Hot water sterilization method Sterilization methods for plate filters Sterilization methods and materials commonly used in cell engineering Sterilization method of pipette tip Sterilization methods for vaccination needles Sterilization methods for glass instruments Sterile weighing method dry sterilization Methods of Disinfection and Sterilization High School Biology Summary of commonly used sterilization methods Method steps and purpose of high pressure sterilization Autoclave heat penetration test method Coating rod sterilization method Moisture method does not require confirmation Sterilization method of coating rod Microbiological methodological confirmation of packaging materials Sterilization method of sterile cotton swabs Microbiological Aseptic Sampling Method

《GB/T 19973.2-2005医用器材的灭菌微生物学方法第二部分：确认灭菌过程的无菌试验》由TC200（全国消毒技术与设备标准化技术委员会）归口，主管部门为国家药品监督管理局。
GB/T 19973的本部分规定了医疗器械在经过低于所规定的灭菌剂量作用后，对其进行无菌试验的一般要求。这些试验适用于对灭菌过程的确认。本部分不适用于:a) 已经过灭菌的日常销售产品的无菌试验；b) 药典无菌试验；c) 生物指示物(包括接种的产品)的培养。

Scope

1.1 This part of GB/T 19973 specifies the general requirements for the sterility test of medical devices after they have been subjected to a sterilization dose lower than the prescribed one. These tests are suitable for the validation of the sterilization process. 1.2 This section does not apply to: a) sterility tests of products that have been sterilized for routine sale; b) pharmacopoeial sterility tests; c) cultivation of biological indicators (including inoculated products).

More samples: YD/T 3934-2021 DL/T 368-2010 DL/T 5154-2012

Sample only — not a preview of GB/T 19973.2-2005

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