YY 1275-2016 Active Industry standards-Medicine

YY 1275-2016 Dry heat (heated air) sterilizers

YY 1275-2016 Dry heat (heated air) sterilizers

Publish Date: 2016-03-23 Implement Date: 2018-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 1275-2016
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Public medical equipment
ICS Name: Disinfection equipment
Publish Date: 2016-03-23
Implement Date: 2018-01-01
Pages: 17 pages

Scope

This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, packaging, user manuals, transportation, and storage for hot air dry heat sterilizers.
This standard applies to dry heat sterilizers that use convective hot air as the sterilization medium (hereinafter referred to as "sterilizers"). These sterilizers are mainly used for sterilizing medical devices and their accessories in laboratories, nursing clinics, hospitals, and other healthcare facilities.
This standard does not apply to conductive or radiation-type dry heat sterilizers. It does not specify safety requirements related to the scope of use risks, nor does it stipulate the confirmation and routine control of dry heat (hot air) sterilization or the requirements for removing pyrogens by dry heat.

Development Information

Word Count: 30 Thousand words Pages: 17 pages

Referenced Standards

GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements IEC 61010-2-040:2005 消毒技术规范 中华人民共和国卫生部(2002年版) GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB/T 4982-2003 Vacuum technology—Quick release couplings-Dimensions—Part 1:Clamped type GB/T 18268-2000 Electrical equipment for measurement, control and laboratory use—EMC requirements GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.21-2010 Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 21:Particular requirements—Test configurations,operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications GB/T 18268.22-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 22:Particular requirements—Test configurations,operational conditions and performance criteria for portable test,measuring and monitoring equipment used in low-voltage distribution systems GB/T 18268.23-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 23:Particular requirements—Test configurations,operational conditions and performance criteria for transducers with integrated or remote signal conditioning GB/T 18268.24-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 24:Particular requirements—Test configurations,operational conditions and performance criteria for insulation monitoring devices according to IEC 61557-8 and for equipment for insulation fault location according to IEC 61557-9 GB/T 18268.25-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 25:Particular requirements—Test configurations,operational conditions and performance criteria for field devices with interfaces according to IEC 61784-1,CP 3/2 GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment GB/T 18268.31-2022 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 31:Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety)—General industrial applications GB/T 18268.32-2022 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 32:Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety)—Industrial applications with specified electromagnetic environment GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.22-2025 Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 22:Particular requirements—Test configurations, operational conditions and performance criteria for portable testing, measuring and monitoring equipment used in low-voltage distribution systems GB/T 18268.21-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 21:Particular requirements—Test configurations,operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications GB/T 191-2025 Graphical symbols marking for handling and storage of packages GB/T 4982-2025 Vacuum technology—Dimensions of clamped-type quick-release couplings

Adopt standards

ANSI/AAMI ST50:2004

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