YY/T 1607-2018 in English

VALID

Radiation sterilization of medical device—Method of dose setting

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

Price(USD)： $310.00
$301.00

Standard No:	YY/T 1607-2018
Document status:	VALID
Title in English:	Radiation sterilization of medical device—Method of dose setting
Title in Chinese:	医疗器械辐射灭菌剂量设定的方法
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:	appropriate radiation dose radiation sterilization radiation dose medical device method medical device
Related Topics:	dosage medical Radiation Dosimetry Equipment Sterilizer Box Sterilization Method box sterilizer box + sterilizer Box + Sterilization + Method class of medical reagents Commonly Used Medical Reagents medical radiation Degradation Methods for Medical Devices medical radiation Degradation Methods for Medical Devices medical dose radiation Medical Test Reagents Validation methods for medical devices Radiation Sterilization Requirements for Medical Devices medical device radiation Medical Device Sterilization Inspection Definition of Sterilized Medical Devices radiation machinery Medical Device Superbugs medical device radiation radiation sterilizer Cobalt 60 radiation sterilization Medical device sterilization box radiation therapy radiation sterilization Sterilizer medical accident analysis Centrifuge sterilization method Annual radiation dose calculation method Non-terminal sterilization methods for medical devices Medical device methodology validation Sterilization method of ultra-clean clothes Sterilization methods for applicators Abscisic acid sterilization method Medical device methodology verification related Medical device methodology validation Class II medical device hardware design Hot water sterilization method Standards and regulations for heavy metal content in medical devices Methods for determining the quality of bacterial agents Medical device size measurement methods Dimensional measurement methods in the field of medical devices European medical device voltage test method Sterilization methods for vaccination needles Radiation sterilization related Medical device radiation protection level testing Sterile weighing method Methodology Validation of Medical Devices Organic solvent sterilization methods yy/t1630-2018 Medical device withstand voltage tester measurement method yy/t1615-2018

本标准规定了GB 18280.2—2015中方法2A和2B的一种改进方法，能够减少确定最小剂量的增量剂量的组数，该最小剂量可以达到预期无菌保证水平。本标准适用于生物负载低或处于低辐射抗力，且证明与历史水平一致时的产品。不适用于生物负载未被评估的产品。

Introduction

This standard provides detailed procedures for determining the appropriate radiation dose for the sterilization of medical devices. It outlines the principles, methods, and requirements necessary to ensure that the selected radiation dose effectively achieves the desired level of microbial reduction while maintaining the integrity and safety of the medical device. The content includes guidance on the selection of appropriate test methods, the establishment of dose-setting criteria, and the documentation of all relevant data throughout the process. It also addresses factors that may influence the effectiveness of radiation sterilization, such as the material composition of the device and the packaging used. This standard is intended to support manufacturers and other stakeholders in the development and validation of radiation sterilization processes for medical devices, contributing to the overall quality and safety of healthcare products.

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

More samples: DL/T 5154-2012 JGJ 94-2008 QC/T 942-2021

Sample only — not a preview of YY/T 1607-2018

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