YY 1275-2016 in English

VALID

Dry heat (heated air) sterilizers

Issued on:2016-03-23
Implemented on:2018-01-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $250.00
$243.00

Standard No:	YY 1275-2016
Document status:	VALID
Title in English:	Dry heat (heated air) sterilizers
Title in Chinese:	热空气型干热灭菌器
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2016-03-23
Implemented on:	2018-01-01
ICS Classification:	11.080.10-Sterilizing equipment
Chinese Classification:	C47-Public medical equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	dry heat sterilizers dry heat sterilizers introduction analysis air filter range ±3℃ ±5℃ temperature uniformity ≤5℃ ≤9℃ heating rate ≥5℃/min key
Related Topics:	Sterilizer thermal quenching Sterilizer Dry heat sterilizer dry heat sterilization Thermal instrument Dry Heat Sterilizer Dry heat rapid sterilizer Air Gram Tablets Dry heat sterilizer Sterile degassing dry heat Space sterilization bag hot air Sterilizer Instrument heat quenching air for thermogravimetry yy-1275 Moist Heat Sterilizer Hot Air Instruments Moist heat sterilizer l-type bacteria small air dryer Micro Air Dryer off % Sterilization tolerance The difference between moist heat sterilization and dry heat sterilization tomy sterilizer The difference between dry heat and moist heat sterilization The difference between dry heat sterilization and moist heat sterilization Sterilizer parameters dry heat heater Hot air dry heat sterilizer High temperature dry heat sterilization Dry heat sterilization standards and regulations Dry heat sterilization verification Hot water sterilization method Dry heat sterilization box industry dry sterilization Heat sterilization reference Dry heat sterilizer industry Sterilizer exhaust emissions

本标准适用于以对流热空气为灭菌介质的干热灭菌器，该灭菌器主要用于实验室、护理诊所、医院和其他医疗保健场所的医疗保健产品及其附件的灭菌。
本标准规定了热空气型干热灭菌器的术语和定义、要求、试验方法、检验规则和标志、包装、使用说明书、运输和储存等内容。
本标准不适用于传导型或辐射型干热灭菌器。

Introduction

Analysis of the core content of the standard

Technical dimensions	160℃-200℃ requirements	201℃-300℃ requirements
Temperature range	±3℃	±5℃
Temperature uniformity	≤5℃	≤9℃
Heating rate	≥5℃/min

Key technical innovations

The standard clearly defines for the first time Door cannot be heated if it is not closed, and it will be automatically locked when the temperature is >40℃. The double-door structure needs to achieve bidirectional interlocking to ensure biological safety.

Sterilization effect verification

According to ISO 11138-4 requirements, Bacillus stearothermophilus is used as a biological indicator to verify the sterilization effectiveness within the range of 160℃-300℃. During the test, ensure that:

The number of surviving biological indicators is ≥1×10⁵ CFU

No growth after 48 hours of culture after sterilization

The positive control culture should grow well

Implementation and application suggestions

Medical institutions should pay special attention when selecting dry heat sterilizers:

Regularly calibrate the temperature sensor (±0.5℃ accuracy)

Check the air filter monthly (0.3μm particle filtration efficiency ≥99.5%)

Establish a sterilization item registration system (refer to Appendix B requirements)

Standard evolution analysis

This standard refers to ANSI/AAMI ST50:2004 but has major differences:

Added special requirements for double door structure (Clause 5.7)

Strengthen the requirement that temperature records cannot be tampered with (5.13.3.1d)

Clearly define the test interface specifications (KF16/KF25 standard interface)

More samples: JC/T 2453-2018 NB/T 47013.2-2015 JJG 21-2008

Sample only — not a preview of YY 1275-2016

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