T/FDSA 0088-2025 Active Group standards

T/FDSA 0088-2025 Guidelines for water quality for sterilization devices, sterilization processes, and cleaning and disinfection equipment in medical products

Publish Date: 2025-08-21 Implement Date: 2025-09-21 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 0088-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Disinfection equipment

Publish Date: 2025-08-21

Implement Date: 2025-09-21

Scope

This document provides requirements for the water quality (hereinafter referred to as "water quality") of sterilizers, sterilization processes, and cleaning and disinfection equipment used to process medical products. This document includes, but is not limited to, water quality requirements directly used for medical product cleaning, thermal and chemical disinfection, rinsing, and sterilization, including water quality standards for feedwater used as steam generators, maintenance water for sterilizers or cleaning and disinfection equipment, and coolant water. This document provides specific guidance on the following aspects: - Water quality for different purposes; - Water treatment systems; - Water distribution and storage; - Water quality monitoring, maintenance, and control; - Investigation of non-compliant results. Note: The guidance provided in this document can also be applied to the water quality specifications required for manual cleaning or disinfection of medical devices (see YY/T 0802 series).