07.100.10 医学微生物学 标准查询与下载
共找到 194 条与 医学微生物学 相关的标准，共 13 页
本标准规定了医用有机硅材料的生物学评价试验方法。 本标准适用于医用有机硅材料的生物学评价。其他医用材料亦可参照采用。
Organic silicon material for medical use--Biological evaluation test methods
- ICS
- 07.100.10
- CCS
- C48
- 发布
- 1996-03-07
- 实施
- 1996-10-01
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
- ICS
- 07.100.10
- CCS
- 发布
- 2023-06
- 实施
- 2023-06
Scope is not provided for this standard
Standard Guide for Evaluating Non-culture Microbiological Tests
- ICS
- 07.100.10
- CCS
- 发布
- 2023-05-03
- 实施
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
- ICS
- 07.100.10
- CCS
- 发布
- 2023-04
- 实施
1.1 The microbial test method outlined in this test method applies to microbial ingress risk assessment of a single-use system (SUS) or its individual components that require integrity testing either by the assembly supplier or the end user of the assembly based on a potential risk of a breach to the product or manufacturing process. 1.2 The aim of microbial ingress testing of sterile SUSs used in biopharmaceutical manufacturing is two-fold: 1.2.1 Firstly, it is used to evaluate the ability of a SUS fluid path to remain sterile after a SUS has been challenged by microbial exposure. Microbial exposure is achieved either by directly placing a SUS into a container of microbial challenge solution, or by delivering an aerosolized microbial challenge onto a SUS that is placed inside a test chamber designed to generate and deliver the aerosol. The choice of the test challenge organism should be justified based on a risk assessment of the SUS and conditions of use. 1.2.2 Additionally, microbial ingress testing can be used to determine the maximum allowable leakage limit (MALL) that does not allow microbial ingress under specific test conditions. The defect size that can be detected by specific physical integrity testing methods (see Test Method E3336) can be correlated to this MALL in order to claim microbial integrity. Test articles bearing calibrated defects over a range of dimensions, including up to a defect size expected to consistently allow microbial ingress as a positive control (defectbased positive control), may be tested to determine the MALL. 1.3 Both purposes for microbial ingress testing as described in 1.2.1 and 1.2.2 can either be conducted by liquid immersion or aerosol exposure. For the purpose described in 1.2.2, the type of exposure should be determined according to the SUS’s use-case conditions and a risk assessment. 1.4 The method used to create a breach, hole or defect in single-use film or in a SUS test article, as well as the analytical method used to physically characterize the defect size is outside of the scope of this test method. The sampling plan for a given test article should be justified with the rationale of sampling size to obtain a statistically meaningful effect (Practice E3244). Determining the appropriate number of SUS test articles will depend on a risk assessment of the SUS and the conditions of its use and is also outside of this test method’s scope. 1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Standard Test Method for Microbial Ingress Testing on Single-Use Systems
- ICS
- 07.100.10
- CCS
- 发布
- 2023-03-15
- 实施
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021) (consolidated version)
- ICS
- 07.100.10
- CCS
- 发布
- 2021-11-01
- 实施
- 2021-11-01
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ICS
- 07.100.10
- CCS
- 发布
- 2021-10-21
- 实施
- 2021-10-21
This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization i
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021
- ICS
- 07.100.10
- CCS
- 发布
- 2021-10-00
- 实施
This document applies to the pre-analytical phase of all test material sent to a medical microbiological laboratory according to DIN EN 12128 for testing for bacteria and fungi. It specifies the minimum requirements for the quality of biological test material, for sampling and tr
Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
- ICS
- 07.100.10
- CCS
- 发布
- 2021-09-00
- 实施
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
- ICS
- 07.100.10
- CCS
- 发布
- 2021-08-31
- 实施
- 2021-08-31
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018/Amd 1:2021); Amendment A1
- ICS
- 07.100.10
- CCS
- 发布
- 2021-08-00
- 实施
- 2021-08-01
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Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
- ICS
- 07.100.10
- CCS
- 发布
- 2021-07-01
- 实施
Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products – Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
- ICS
- 07.100.10
- CCS
- 发布
- 2021-06-23
- 实施
- 2021-06-23
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
- ICS
- 07.100.10
- CCS
- 发布
- 2021-06-00
- 实施
Sterilization of healthcare products – Microbiological methods – Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
- ICS
- 07.100.10
- CCS
- 发布
- 2021-03-24
- 实施
- 2021-03-24
Sterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
- ICS
- 07.100.10
- CCS
- 发布
- 2021-03-22
- 实施
- 2021-03-22
Test method for repetitiveness of bacteria reduction activity
- ICS
- 07.100.10
- CCS
- 发布
- 2021-03-22
- 实施
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ICS
- 07.100.10
- CCS
- 发布
- 2021-03-11
- 实施
- 2021-03-11
Sterilization of healthcare products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
- ICS
- 07.100.10
- CCS
- 发布
- 2021-03-00
- 实施
1.1 The purpose of this guide is to assist users and producers of non-culture microbiological tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Culture test procedures such as the Heterotrophic (Standard) Plate Count, the Most Probable Number (MPN) method and the Spread Plate Count are widely cited and accepted for the enumeration of microorganisms. However, these methods have their limitations, such as performance time. Moreover, any given culture test method typically recovers only a portion of the total viable microbes present in a sample. It is these limitations that have recently led to the marketing of a variety of non-culture procedures, test kits and instruments. 1.2 Culture test methods estimate microbial population densities based on the ability of mircoorganisms in a sample to proliferate in or on a specified growth medium, under specified growth conditions. Non-culture test methods attempt to provide the same or complimentary information through the measurement of a different parameter. This guide is designed to assist investigators in assessing the accuracy and precision of non-culture methods intended for the determination of microbial population densities or activities. 1.3 It is recognized that the Heterotrophic Plate Count (HPC) does not recover all microorganisms present in a product or a system (1, 2).2 When this problem occurs during the characterization of a microbiological population, alternative standard enumeration procedures may be necessary, as in the case of sulfate-reducing bacteria. At other times, chemical methods that measure the rates of appearance of metabolic derivatives, the utilization of contaminated product components or genetic profile of the microbial population might be indicated. In evaluating non-culture tests, it is possible that the use of these alternative standard procedures might be the only means available for establishing correlation. In such cases, this guide can serve as a reference for those considerations. 1.4 Because there are so many types of tests that could be considered non-culture based, it is impossible to recommend a specific test protocol with statistical analyses for evaluating the tests. Instead, this guide should assist in determining what types of tests should be considered to verify the utility and identify the limitations of the nonconventional test. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Standard Guide for Evaluating Non-culture Microbiological Tests
- ICS
- 07.100.10
- CCS
- 发布
- 2020-12-01
- 实施
