T/FDSA 0137-2026 Active Group standards

T/FDSA 0137-2026 One-time use flushing suction device

Publish Date: 2026-04-02 Implement Date: 2026-05-02 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 0137-2026

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical instruments and materials

Publish Date: 2026-04-02

Implement Date: 2026-05-02

Scope

This document specifies the classification and marking, general requirements, technical requirements, test methods, inspection rules, marking, packaging, and transportation of single-use irrigation aspirators for medical devices. This document applies to clinical surgeries, particularly those involving laparoscopy, thoracoscopy, and other procedures. The single-use irrigation aspirators (hereinafter referred to as "irrigation aspirators") are used to clean the surgical field through irrigation and to aspirate out accumulated fluids, blood, and tissue debris during these procedures.