07.100.10 醫學微生物學 標準查詢與下載
共找到 195 條與 醫學微生物學 相關的標準，共 13 頁
本標準規定了醫用有機硅材料的生物學評價試驗方法。 本標準適用于醫用有機硅材料的生物學評價。其他醫用材料亦可參照采用。
Organic silicon material for medical use--Biological evaluation test methods
- ICS
- 07.100.10
- CCS
- C48
- 發布
- 1996-03-07
- 實施
- 1996-10-01
Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
- ICS
- 07.100.10
- CCS
- 發布
- 2024-09-15
- 實施
1.1 Inclusions This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. 1.2 Exclusions 1.2.1 This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). 1.2.2 This document does not address setting specific endotoxin limit specifications.
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
- ICS
- 07.100.10
- CCS
- 發布
- 2023-06
- 實施
- 2023-06
Scope is not provided for this standard
Standard Guide for Evaluating Non-culture Microbiological Tests
- ICS
- 07.100.10
- CCS
- 發布
- 2023-05-03
- 實施
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
- ICS
- 07.100.10
- CCS
- 發布
- 2023-04
- 實施
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
- 發布
- 2023-03-15
- 實施
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
- 發布
- 2021-11-01
- 實施
- 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
- 發布
- 2021-10-21
- 實施
- 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
- 發布
- 2021-10-00
- 實施
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
- 發布
- 2021-09-00
- 實施
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
- 發布
- 2021-08-31
- 實施
- 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
- 發布
- 2021-08-00
- 實施
- 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
- 發布
- 2021-07-01
- 實施
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
- 發布
- 2021-06-23
- 實施
- 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
- 發布
- 2021-06-00
- 實施
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
- 發布
- 2021-03-24
- 實施
- 2021-03-24
Test method for repetitiveness of bacteria reduction activity
- ICS
- 07.100.10
- CCS
- 發布
- 2021-03-22
- 實施
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
- 發布
- 2021-03-22
- 實施
- 2021-03-22
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
- 發布
- 2021-03-11
- 實施
- 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
- 發布
- 2021-03-00
- 實施
