YY/T 0679-2016 Active Industry standards-Medicine

YY/T 0679-2016 Low temperature steam and formaldehyde sterilizers for medical purposes

YY/T 0679-2016 Low temperature steam and formaldehyde sterilizers for medical purposes

Publish Date: 2016-07-29 Implement Date: 2017-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0679-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Disinfection equipment

Publish Date: 2016-07-29

Implement Date: 2017-06-01

Pages: 35 pages

Scope

This standard specifies the terms and definitions, types and markings, requirements, test methods, markings and user manuals, packaging, transportation, and storage of medical low-temperature steam formaldehyde sterilizers (hereinafter referred to as sterilizers).
The sterilizers specified in this standard mainly use a mixture of low-temperature steam and formaldehyde gas to sterilize heat-sensitive medical items.
This standard does not address the validation of the effectiveness of the low-temperature steam formaldehyde sterilization process and daily quality control requirements, but the test methods and equipment in this standard can be referenced for the validation and daily control of sterilizers.
This standard does not stipulate safety requirements related to the scope of use risks.

Development Information

Word Count: 64 Thousand words Pages: 35 pages

Replace the following standards

YY 0679-2008 Sterilizers for medical purposes-Low temperature steam and formaldhyde sterilizers

Referenced Standards

IEC 61010-2-040:2005 EN 60584-2 EN 60751 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 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements 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 18281.5-2015 Sterilization of health care products—Biological indicator—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes GB/T 19633-2005 Packaging for terminally sterilized medical devices GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes YY/T 0883-2013 Specification of process challenge devices and indicator systems for steam penetration testing GB/T 18281.5-2024 Sterilization of health care products—Biological indicators—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—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 191-2025 Graphical symbols marking for handling and storage of packages

Adopt standards

EN 14180:2003+A2:2009

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