YY/T 0646-2015 Replaced Industry standards-Medicine

YY/T 0646-2015 Small steam sterilizers—Automatic type

YY/T 0646-2015 Small steam sterilizers—Automatic type

Publish Date: 2015-03-02 Implement Date: 2016-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0646-2015

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Disinfection equipment

Publish Date: 2015-03-02

Implement Date: 2016-01-01

Pages: 50 pages

Scope

This standard specifies the classification and basic parameters, requirements, test methods, and inspection rules for automatic control type small steam sterilizers.
This standard applies to automatic control type small steam sterilizers (hereinafter referred to as sterilizers) that generate steam by electric heating or connect to external steam sources, with a sterilization chamber volume not exceeding 60 L and unable to accommodate a single sterilization unit (300 mm × 300 mm × 600 mm).
This standard does not apply to the sterilization of sealed liquids.
This standard does not apply to vertical steam sterilizers and portable steam sterilizers.
This standard does not stipulate safety requirements related to the scope of use risks, nor does it stipulate requirements for the confirmation and routine control of moist heat sterilization.

Development Information

Word Count: 95 Thousand words Pages: 50 pages

Replace the following standards

YY 0646-2008 Small steam sterilizers—Automatic type

Superseded by the following standards

YY/T 0646-2022 Small steam sterilizers

Referenced Standards

GB 150-1998 Steel pressure vessels GB/Z 150-2025 Guide for magnetizing behaviour of permanent magnets GB/T 150.1-2011 Pressure vessels—Part 1:General requirements GB/T 150.1-2024 Pressure vessels—Part 1:General requirements GB/T 150.2-2011 Pressure vessels—Part 2:Materials GB/T 150.2-2024 Pressure vessels—Part 2:Materials GB/T 150.3-2011 Pressure vessels—Part 3:Design GB/T 150.3-2024 Pressure vessels—Part 3:Design GB/T 150.4-2011 Pressure vessels—Part 4:Fabrication,inspection and testing,and acceptance GB/T 150.4-2024 Pressure vessels—Part 4:Fabrication,inspection and testing,and acceptance GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 191-2025 Graphical symbols marking for handling and storage of packages 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 12244-1989 General specification for pressure reducing valves GB/T 12244-2006 General requirements for pressure reducing valves GB/T 12244-2025 Pressure reducing valves—General requirements GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment 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 18268.1-2025 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 18268.21-2025 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 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 18268.22-2025 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 18268.23-2010 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 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1:General requirements GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization GB 18281.3-2015 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes GB/T 18281.3-2024 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements GB 18282.1-2015 Sterilization of health care products—Chemical indicator—Part 1:General requirements GB/T 18282.1-2025 Sterilization of health care products—Chemical indicators—Part 1:General requirements GB/T 19971-2005 Sterilization of health care products—Vocabulary GB/T 19971-2015 Sterilization of health care products—Vocabulary GB/T 19971-2026 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards GB/T 19974-2005 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices YY 0154-2005 Spring type safety valve on pressure steam sterilizer YY 0154-2013 Spring full lift safety valves on pressure steam sterilizer YY/T 0159-2005 Steam trap fitted on pressure steam sterilizer YY/T 0159-1994 The pressure steam sterilization equipment uses a hydrophobic valve IEC 61010-2-040:2005

Adopt standards

EN 13060:2004

Related Standards

GB 15979-2002 Replaced

GB 15979-2002 Hygienic standard for disposable sanitary products

Publish Date: 2002-03-05

YY 0504-2005 Replaced

YY 0504-2005 Portable mode steam sterilizers

Publish Date: 2005-04-05

YY 1007-2005 Replaced

YY 1007-2005 Vertical mode steam sterilizers

Publish Date: 2005-12-07

GB 4793.8-2008 Replaced

GB 4793.8-2008 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 2-042:Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes

Publish Date: 2008-03-24

YY 0646-2008 Replaced

YY 0646-2008 Small steam sterilizers—Automatic type

Publish Date: 2008-04-25

YY 0215-2008 Replaced

YY 0215-2008 Medical ozone disinfecting cabinets

Publish Date: 2008-10-17