YY/T 0618-2017 in English

VALID

Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing

Issued on:2017-02-28
Implemented on:2018-01-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $490.00
$476.00

Standard No:	YY/T 0618-2017
Document status:	VALID
Title in English:	Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing
Title in Chinese:	医疗器械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:	2017-02-28
Implemented on:	2018-01-01
Superseding:	YY/T 0618-2007 Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing
ICS Classification:	11.040.01-Medical equipment in general
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	medical devices conventional devices test methods spinal fluid contact devices core terms termsdefinitionkey points bacterial endotoxin test
Related Topics:	yy/t 0618-2017 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 Batch Bacteria Instruments Bacterial endotoxin test method routine monitoring and skip batch inspection for medical devices yy/t0618-2017 YY/T 0618 yy/t+0618 yy/t+0618+2017 endotoxin Bacterial endotoxin Commonly Used Medical Reagents Toxin test Bacteria test review yy0618 Inter-batch and intra-batch differences Superbugs and machinery Bacteria test Medical Test Reagents yy0618-2017 medical bacteria fungus Endotoxin Analysis yy+0618 Medical Device Superbugs Detection of endotoxin yy/t 0618- Medical device test method validation medical monitor test constant element Test methods for detecting bacteria Medical test routine Endotoxin test instrument bacteria 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 Medical device methodology validation skip batch Pyrogen and endotoxin method applicability Bacterial endotoxin limulus reagent test method Preparation method of bacterial endotoxin test sample Medical device methodology verification related Medical device methodology validation Ultrapure water endotoxin detection method What are the instrument testing methods for syphilis? 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 European medical device voltage test method Serum endothelin test method Methodology Validation of Medical Devices Limulus reagent bacterial endotoxin detection method Commonly used methods to detect cytotoxic effects are Sample processing method for bacterial endotoxin detection

本标准规定了测定医疗器械、组件或原材料的细菌内毒素试验方法的基本准则。
本标准适用于医疗器械细菌内毒素常规监控与跳批检验。

Introduction

Standard Overview

YY/T 0618-2017 replaces the 2007 version of the standard. The main updates include: standard name adjustment, new terminology (endotoxin working standard, geometric mean endpoint, etc.), and revision of appendix content. This standard is applicable to endotoxin detection of medical devices, components and raw materials, and is not applicable to pyrogen evaluation of non-bacterial endotoxins.

Analysis of core terms

Terms	Definition	Key points
Bacterial endotoxin test (BET)	A method of detecting activity by reacting Limulus reagent with endotoxin	Including three techniques: gel method, colorimetric method and turbidity method
Maximum effective dilution (MVD)	The maximum allowable dilution ratio to overcome interference	Calculation formula: MVD=test endotoxin limit/λ
Skip batch inspection	A plan to reduce inspection frequency based on process control	Requires FMEA and other risk assessments

Comparison of test methods

Three main technical features:

Gel technology: easy to operate, low equipment requirements, subjective result interpretation
Colorimetric/turbidity endpoint method: requires a microplate reader, with a linear range of 1 logarithmic level
Kinetic method: high degree of automation, with a linear range of up to 4 logarithmic levels

The standard recommends selecting an appropriate method based on laboratory conditions and sample characteristics, and revalidation is required when changes are made.

Key points for implementation

Sample preparation: The volume of the extract must ensure the detection limit, and multi-component products must consider the overall extraction strategy
Interference treatment: Methods such as pH adjustment, ion concentration adjustment, and ultrafiltration concentration must be used after verification
Skip batch inspection: The prerequisites of stable production process, qualified historical data, and critical control point monitoring must be met

Background of standard evolution

Bacterial endotoxin testing began in the 1970s and was officially adopted by USP in 1993. The limit values for medical devices are set based on safety considerations:

Conventional devices: 20 EU/unit
Cerebral spinal fluid contact devices: 2.15 EU/unit
Limits for extracts: 0.5 EU/mL (conventional)/0.06 EU/mL (cerebrospinal fluid)

In 2004, AAMI research confirmed that the current limits already include safety factors, and no additional recovery rate requirements are required.

More samples: DL/T 5154-2012 JC/T 2453-2018 YD/T 3934-2021

Sample only — not a preview of YY/T 0618-2017

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