T/FDSA 027-2021 Active Group standards

T/FDSA 027-2021 Acetylene oxide low temperature sterilizer general technical standards

Publish Date: 2021-12-14 Implement Date: 2021-12-31 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: T/FDSA 027-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Disinfection equipment

Publish Date: 2021-12-14

Implement Date: 2021-12-31

Scope

Scope: This document specifies the terms and definitions, requirements, test methods, marking and user manuals, packaging, transportation, and storage of low-temperature sterilizers using peracetic acid (hereinafter referred to as sterilizers). This document applies to low-temperature sterilizers that use peracetic acid as the sterilization medium and are capable of generating plasma. This document does not specify safety requirements related to the scope of use risks, nor does it specify requirements for the validation and routine control of peracetic acid low-temperature sterilizers. Main technical content: GBZ 159 - Sampling Standards for Monitoring Harmful Substances in Workplace Air; GB/T 191 - Graphic Symbols for Packaging and Transportation; GBZ/T 300.48 - Determination of Toxic Substances in Workplace Air - Part 48: Ozone and Hydrogen Peroxide; GB/T 700 - Carbon Structural Steel; GB/T 1173 - Cast Aluminum Alloy; GB/T 1220 - Stainless Steel Rod; GB/T 2060-1989 - Brass Strip; GB 4793.1 - Safety Requirements for Electrical Equipment Used in Measurement, Control, and Laboratories - Part 1: General Requirements; GB 4793.4 - Safety Requirements for Electrical Equipment Used in Measurement, Control, and Laboratories - Part 4: Special Requirements for Sterilizers and Cleaning Disinfectors Used to Process Medical Materials; GB/T 14710 - Electrical Environmental Requirements and Test Methods for Medical Use; GB/T 18268.1 - Electrical Equipment for Measurement, Control, and Laboratories - Electromagnetic Compatibility Requirements - Part 1: General Requirements; GB/T 18281.1 - Sterilization of Healthcare Products - Biological Indicators - Part 1: General Principles; GB/T 19104 - Peracetic Acid Solution; GB/T 19192-2003 - Hygiene Requirements for Contact Lens Solutions; YY/T 0466.1 - Medical Devices - Symbols for Labeling, Marking, and Providing Information on Medical Devices - Disinfection Technology Specifications - 2002 Edition