Five Aspects Of The ISO 11737 | 合法醫療器材資訊網

2018年7月23日—#1:BioburdenMethodSuitability·#2:RecoveryEfficiency·#3:LimitofDetection·#4:TestingofPackaging·#5:TableofResponsibilities

A new version of the ISO document regarding bioburden testing was recently published. Its designation is ANSI/AAMI/ISO 11737-1:2018—Sterilization of health care products—Microbiological Methods—Part 1: Determination of a population of microorganisms on products. Though the document has a number of changes, this article will highlight the top five things manufacturers need to know. #1: Bioburden Method Suitability Bioburden test methods are dependent on the ability of microorganisms to replicate in the bioburden test system. Some products tested for bioburden can release substances that inhibit microorganism replication. The inhibitory substance is typically known to the manufacturer because it is intentionally included as part of the product (i.e., chemical or antibiotic). Sometimes, however, an unknown inhibitory substance can be present that can be problematic because the manufacturer may believe there is no need to test for inhibitory subs...

Using Recovery Tests to Assess Bioburden Procedures ... | 合法醫療器材資訊網

There are three reasons to conduct a bioburden recovery test: to evaluate the test procedure in order to improve recovery, to assess antimicrobial qualities of the ... Read More

Five Aspects Of The ISO 11737 | 合法醫療器材資訊網

2018年7月23日 — #1: Bioburden Method Suitability · #2: Recovery Efficiency · #3: Limit of Detection · #4: Testing of Packaging · #5: Table of Responsibilities Read More

Medical Device Bioburden Testing | 合法醫療器材資訊網

Ideally, a recovery efficiency should be established prior to the start of any bioburden test. It should be performed on a minimum of three samples. The recovery ... Read More

[安全性評估]微生物試驗(含滅菌確效) | 合法醫療器材資訊網

微生物測試. 生物負荷量試驗(Bioburden test) 生物負荷量回收率試驗(Bioburden recovery test) 落菌試驗(Settle plate test). 大腸桿菌偵測(E. coli detection). Read More

Bioburden Testing Procedures and Tips | 合法醫療器材資訊網

Validation procedures consist of assessment of the adequacy of the extraction techniques to remove microorganisms (Recovery Efficiency), the calculation of a ... Read More

Bioburden Determination | 合法醫療器材資訊網

Bioburden testing Laboratory including validation ... the recovery rate should be at least 50 %, otherwise the parameters of the test method must be changed and ... Read More

Bioburden method validation | 合法醫療器材資訊網

The percent recovery is used to calculate a correction factor which is then applied to the Bioburden test numbers for the product. In this way routine bioburden tests ... Read More

Bioburden Testing and Sterility Testing of Medical Devices | 合法醫療器材資訊網

The purpose of the bioburden suitability test (also called method validation) is to ensure that the bioburden test method is effective in recovering microorganisms ... Read More

Bioburden | 合法醫療器材資訊網

Bioburden is the sum of the microbial contributions from a number of ... Principle of the test. Microbial ... correction factor for recovery efficiency is calculated. Read More

ISO 11737-1 | 合法醫療器材資訊網

1 General. C. · 2 Validation using repetitive recovery. C. · 3 Product inoculation method. C. · 4 Bioburden recovery efficiency for complex product testing. C. · 5 Data ... Read More

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