YY/T 1608-2018 in English

VALID

Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits

Issued on:2018-06-26
Implemented on:2019-07-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $230.00
$224.00

Standard No:	YY/T 1608-2018
Document status:	VALID
Title in English:	Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits
Title in Chinese:	医疗器械辐射灭菌验证剂量实验和灭菌剂量审核的抽样方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2018-06-26
Implemented on:	2019-07-01
ICS Classification:	11.080.01-Sterilization and disinfection in general
Chinese Classification:	C47-Public medical equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	verification dose experiments validation dose experiments radiation sterilization radiation sterilization methods medical device sampling method
Related Topics:	Sterilizing dose Radiation Sterilization Metrological Validation Sterilizer Validation System dosage medical Sterilization Dose Audit Quencher Sterilizer Box Sterilization Method Preparation sterilization box sterilizer Radiation Dose Audit box + sterilizer laboratory radiation Box + Sterilization + Method Methodology Validation Sample experimental dose Validation of medical devices and Sterilizer Validation System Sterilizer Validator Sterilizer Validator Sterilizer Validation Sterilizer Validator medical dose radiation Sterilization methods in the laboratory content after sterilization Laboratory Sterilization Methods Laboratory Sterilization Methods Medical Test Reagents Verification methods for medical device products Validation methods for medical devices Radiation Sterilization Requirements for Medical Devices Medical Device Sterilization Inspection Quantitative experiment Medical device test method validation Product verification methods for medical devices Cobalt 60 radiation sterilization Methods of Laboratory Sterilization Medical device sterilization box Experimental sterilization Sterilization Lot Sampling + Product radiation dose Sterilizer medical accident analysis USP Sterility Analytical Method Validation Centrifuge sterilization method Fermentation tank sterilization experiment report Common sterilization methods for surgical instruments and accessories Medical device methodology validation Commonly used bacteriostatic and sterilizing methods Sterilization pot metering Sterilization method of ultra-clean clothes Sterilization methods for applicators Abscisic acid sterilization method Medical device methodology verification related Medical device methodology validation Dry heat sterilization verification Medical Methodology Validation Hot water sterilization method Methods for determining the quality of bacterial agents Sterilization method of pipette tip Suspension content method validation Sterilization methods for vaccination needles Radiation sterilization related Sterile weighing method Methodology Validation of Medical Devices Sterilization liquid sampling method Organic solvent sterilization methods yy/t1630-2018 Sterilization method of coating rod yy/t1615-2018

本标准规定了GB 18280.2—2015中灭菌剂量选择和审核的一种改进方法，该方法在确保产品达到预期无菌保证水平的同时，可以减少要求的产品单元数量，并阐述了验证剂量实验和灭菌剂量审核的抽样方案。本标准适用于GB 18280.2—2015中灭菌剂量选择和审核在确保产品达到预期无菌保证水平时的抽样。

Introduction

This standard provides specific guidelines for the sampling methods used in validation dose experiments and the review of sterilization doses in the context of radiation sterilization for medical devices. It outlines procedures for ensuring the effectiveness and reliability of the sterilization process, focusing on the proper selection and evaluation of samples. The document covers various aspects including the determination of appropriate sample sizes, the conditions under which samples should be tested, and the criteria for assessing the results of these tests. It also addresses the documentation and reporting requirements necessary to support the validation and verification of sterilization processes. The standard is intended to assist manufacturers and regulatory bodies in establishing a consistent and scientifically sound approach to the validation and monitoring of radiation sterilization methods applied to medical devices.

*** Please note: This description may not be accurate, please refer to the official documentation.

More samples: YD/T 3934-2021 JJG 21-2008 NB/T 47013.2-2015

Sample only — not a preview of YY/T 1608-2018

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