YY/T 1276-2016 in English

VALID

Requirements for the development,validation and routine control of dry heat sterilization process for medical devices

Issued on:2016-03-23
Implemented on:2017-01-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $630.00
$612.00

Standard No:	YY/T 1276-2016
Document status:	VALID
Title in English:	Requirements for the development,validation and routine control of dry heat sterilization process for medical devices
Title in Chinese:	医疗器械干热灭菌过程的开发、确认和常规控制要求
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2016-03-23
Implemented on:	2017-01-01
ICS Classification:	11.040.30-Surgical instruments and materials
Chinese Classification:	C47-Public medical equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	dry heat sterilization process dry heat sterilization heat sterilization dry heat medical devices scopethis standard
Related Topics:	Requirements for development, validation and routine control of sterilization process for sterilized medical devices Sterilization development Requirements for development, validation and routine control of dry heat sterilization process for medical devices ISO 11137-1 Validation and routine control of sterilization processes for medical devices Medical Device Technology Development dry equipment Validation and Control Series of Medical Device Sterilization Process Medical Device Product Development Process Sterilization Confirmation of Sterile Medical Devices Class I medical device development Class II medical device development yy t 1276-2016 How to confirm the special process What are the commonly used controllers? Temperature and time required for dry heat sterilization Commonly used sterilization methods for fermentation tanks Dry heat sterilization standards and regulations Analytical method development Instrument validation yy/t 1276-2016

本标准适用于采取干热方式对医疗器械进行灭菌和去热原的过程。
本标准规定了医疗器械在干热灭菌过程中的开发、确认和常规控制要求。
本标准不适用于红外线或微波灭菌。

Scope

This standard specifies the requirements for the development, validation and routine control of medical devices during dry heat sterilization. This standard mainly relates to dry heat sterilization. It also specifies the requirements and provides relevant guidance on the depyrogenation process using dry heat for sterilization. This standard does not specify requirements for the development, validation, and routine control of sterilization processes used to inactivate spongiform encephalopathy pathogens such as scrapie, bovine spongiform encephalopathy, and Creutzfeldt-Jakob disease. This standard does not apply to infrared or microwave sterilization. This standard does not specify medical devices labeled "sterile" in detail. See the requirements of EN 556-1. This standard does not detail the quality management system that controls all production stages of medical device products. This standard does not specify occupational safety requirements related to the design and operation of dry heat sterilization and depyrogenation equipment.

More samples: JGJ 94-2008 DL/T 368-2010 JC/T 2453-2018

Sample only — not a preview of YY/T 1276-2016

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