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EJ/T 1243-2017Bioburden data analysis method for medical device radiation sterilization to confirm radiation sterilization dose (English PDF)

医疗器械辐射灭菌确认辐射灭菌剂量的生物负载数据分析方法

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Issued by

State Administration of Science, Technology and Industry for National Defense

Level / Type

National · Recommended

Issue date

November 7, 2017

Implementation date

April 1, 2018

Scope

EJ/T 1243-2017 is the English-translated version of 医疗器械辐射灭菌确认辐射灭菌剂量的生物负载数据分析方法.

EJ/T 1243-2017 — This standard specifies the requirements for statistical data of medical device bioburden data; requirements for selection of bioburden statistical data; monitoring of biological load levels and processing of abnormal data; trend analysis of bioburden data; and specific work examples. This standard applies to medical device organisms.

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Document preview — EJ/T 1243-2017

National Standard of the People's Republic of China

Classification: F 50

Issued by: State Administration of Science, Technology and Industry for National Defense

What this standard covers1
Document data2

What this standard covers

This standard specifies the requirements for statistical data of medical device bioburden data; requirements for selection of bioburden statistical data; monitoring of biological load levels and processing of abnormal data; trend analysis of bioburden data; and specific work examples. This standard applies to medical device organisms. Statistics and selection of load data.

Document data

Chinese classification (CCS): F50.

Estimated length of the Chinese original: 17,142 words.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 11 pages — is available in the English PDF.

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