YY/T 0646-2022 Active Industry standards-Medicine

YY/T 0646-2022 Small steam sterilizers

YY/T 0646-2022 Small steam sterilizers

Publish Date: 2022-05-18 Implement Date: 2023-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: YY/T 0646-2022
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Public medical equipment
ICS Name: Disinfection equipment
Publish Date: 2022-05-18
Implement Date: 2023-06-01
Pages: 43 pages

Scope

This document specifies the types of sterilization cycles, requirements, test methods, and inspection rules for small pressure steam sterilizers (hereinafter referred to as sterilizers).
This document applies to automatically controlled small pressure steam sterilizers that generate steam by electric heating or connect to external steam sources, have side-opening sterilization chambers, a volume of less than 60 L, cannot accommodate a single sterilization unit (300 mm × 300 mm × 600 mm), and have a rated working pressure of no more than 0.25 MPa with a preset sterilization temperature ranging from 115 ℃ to 138 ℃.
Note: In this document, unless otherwise specified as absolute pressure, all pressures refer to gauge pressure.
This document does not apply to vertical pressure steam sterilizers, portable pressure steam sterilizers, cassette steam sterilizers, or liquid sterilization.
This document does not specify safety requirements related to the risk of use, nor does it stipulate requirements for the validation and routine control of moist heat sterilization.

Development Information

Word Count: 85 Thousand words Pages: 43 pages

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Referenced Standards

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 4793.4-2001 Safety requirements for electrical equipment for measurement, control and laboratory use—Particular requirements for autoclaves using steam for the treatment of medical materials and for laboratory process GB 4793.4-2019 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 4:Particular requirements for sterilizers and washer-disinfectors used to treat medical materials 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 18281.3-2000 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 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 19971-2005 Sterilization of health care products—Vocabulary GB/T 19971-2015 Sterilization of health care products—Vocabulary 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/T 0698.1-2011 Packaging materials for terminal sterilized medical devices—Part 1:Co-extrusion plastic films used for vacuum forming packaging—Requirements and test methods YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods YY/T 0698.2-2022 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods YY/T 0698.3-2009 Packaging materials for terminal sterilized medical devices—Part 3:Paper for use in the manufacture of paper bags(specified in YY/T 0698.4)and in the manufacture of pouches and reels(specified in YY/T 0698.5)—Requirements and test methods YY/T 0698.4-2009 Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods YY/T 0698.5-2009 Packaging materials for terminal sterilized medical devices—Part 5:Heat and self-sealable pouches and reels of paper and plastic film construction—Requirements and test methods YY/T 0698.5-2023 Packaging materials for terminal sterilized medical devices—Part 5:Sealable pouches and reels of porous materials and plastic film construction—Requirements and test methods YY/T 0698.6-2009 Packaging materials for terminal sterilized medical devices—Part 6:Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation—Requirements and test methods YY/T 0698.7-2009 Packaging materials for terminal sterilized medical devices—Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation—Requirements and test methods YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices—Part 8:Re-usable sterilization containers for steam sterilizers—Requirements and test methods YY/T 0698.9-2009 Packaging materials for terminally sterilized medical devices—Part 9:Uncoated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids—Requirements and test methods YY/T 0698.10-2009 Packaging materials for terminally sterilized medical devices—Part 10:Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches,reels and lids—Requirements and test methods GB/T 18281.3-2024 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization processes GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements GB/T 18282.1-2025 Sterilization of health care products—Chemical 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 19971-2026 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards

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