T/CATE 0002-2024 Pelvic Support Technology Specification for Urinary Incontinence

Scope

Scope: This document specifies the scope of urinary incontinence slings, normative referenced documents, classification, requirements, test methods, type testing, labels, instructions, packaging, transportation, storage, expiration date, and other content. This document applies to woven urinary incontinence slings (hereinafter referred to as slings) used in posterior pubic and transobturator vaginal tension-free mid-urethral sling procedures. This product is intended for patients suffering from stress urinary incontinence caused by excessive urethral mobility and/or sphincter dysfunction in women. This document does not apply to urinary incontinence slings containing absorbable materials. Main technical content: The purpose of establishing this technical specification is to unify the type and performance requirements of synthetic urinary incontinence slings, and to guide the standardized design and production of urinary incontinence sling products.

Development Information

Related Standards