YY/T 0618-2007 in English

SUPERSEDED

Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing

Issued on:2007-07-02
Implemented on:2008-03-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $340.00
$330.00

Standard No:	YY/T 0618-2007
Document status:	SUPERSEDED
Superseded by:	YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing
Superseded on:	2018-01-01
Title in English:	Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing
Title in Chinese:	细菌内毒素试验方法常规监控与跳批检验
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2007-07-02
Implemented on:	2008-03-01
ICS Classification:	11.040.01-Medical equipment in general
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	bacterial endotoxins bacterial endotoxin test methods test methodologies test methods bacterial
Related Topics:	Toxin V toxin bacteria Delta toxin yy/t 0618-2017 yy0618-2007 yy/t+0618-2017 yy/t 0618 2017 YY/T 0618-2007 YY/T+0618-2007 yy/t0618 Bacteria monitoring yy t 0618 2017 yy+t+0618+2017 Bacterial endotoxin test method routine monitoring and skip batch inspection Bacterial endotoxin test method routine monitoring and skip batch inspection for medical devices yy/t0618-2017 yy/t 0242-2007 YY/T 0618 yy/t+0618 yy/t+0618+2017 bacteria in english yy/t 0197.5-2007 Bacterial endotoxins - test methodology, routine testing and alternate batches endotoxin Method validation batches Batch Release Inspection Bacterial endotoxin Intra-assay detection limit Domestic and foreign third-party inspection and Toxin test How to detect endotoxin Bacteria test Bacteria test box review yy0618 Inter-batch and intra-batch differences Bacteria test yy 0618 Near Infrared Batch Inspection regular edition yy+0618 Detection Endotoxin Detection yy/t 0618- test constant element bacteria bacteria in progress Test methods for detecting bacteria Monitoring and detection method l-type bacteria test Endotoxin test Bacteria test tube Intra-assay and inter-assay precision inspection lot Endotoxin testing process Are plant pathogenic bacterial toxins endotoxins or exotoxins? Sterility testing and parametric release calcium chloride bacterial endotoxin Bacterial endotoxin quality Chinese Pharmacopoeia bacterial endotoxin detection method Bacterial heme detection method Lyophilized powder endotoxin detection method Chinese Pharmacopoeia Bacterial Endotoxins Test Method Bacterial endotoxin detection method steps Bacterial endotoxin detection method video skip batch National standard endotoxin Pyrogen and endotoxin method applicability Bacterial endotoxin limulus reagent test method Preparation method of bacterial endotoxin test sample Luciferase method for detecting bacteria Engineering Bacteria Experimental Methods Ultrapure water endotoxin detection method Method for detection of bacterial endotoxins in oils Commonly used methods for bacterial detection Endotoxin detection method in dialysis water Method for detecting bacterial toxoid using shark reagent A commonly used method to detect cytotoxic effects is Chinese Pharmacopoeia Bacterial Endotoxins Serum endothelin test method Internal standard method for sewage poison testing method General testing method for bacteriological testing Limulus reagent bacterial endotoxin detection method Methods for determination of bacterial endotoxins in the Pharmacopoeia Methods to test bacterial resistance yy/t0242-2007 Commonly used bacterial counting methods include endotoxin standard in english Commonly used methods to detect cytotoxic effects are Ethylene oxide endotoxin test method Sample processing method for bacterial endotoxin detection

本标准规定了适用于测定医疗器械、组件或原材料的细菌内毒素试验方法的基本准则。
本标准给出的细菌内毒素试验方法包括定性和定量两种方法。
本标准不适用于测定细菌内毒素之外的热原。

Scope

This standard specifies basic guidelines for test methods for the determination of bacterial endotoxins in medical devices, components or raw materials. Note: Although the scope of this standard is limited to medical devices, the requirements specified and the guidance given in this standard may also apply to other medical products. The bacterial endotoxin test methods given in this standard include qualitative and quantitative methods. This standard does not apply to the determination of pyrogens other than bacterial endotoxins. This standard does not specify acceptable levels of bacterial endotoxins. Note: Acceptable levels of bacterial endotoxins should be referred to applicable standards.

More samples: DL/T 368-2010 QC/T 942-2021 NB/T 47013.2-2015

Sample only — not a preview of YY/T 0618-2007

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