Overview
ISO 19351:2019 - Fallopian rings: Requirements and test methods defines the minimum requirements and specified test methods for fallopian rings used for tubal occlusion as a method of permanent contraception. Fallopian rings are elastic medical‑grade silicone bands implanted surgically (laparoscopically or open surgery) to occlude the fallopian tube. The standard applies to the rings themselves (provided sterile, typically as a set of two) and does not cover applicators or placement accessories.
Key topics and requirements
The standard organizes requirements and validated test methods across product, packaging and biological safety topics:
- Physical requirements: dimensional checks, tensile properties, elastic memory, repeat loading strength and visible defect inspection. (Detailed procedures are given in normative annexes.)
- Mechanical interaction: tests for loading force required when used with a ring applicator (applicator not standardized here).
- Packaging and sterility: packing mode, primary pouch, instructions for use, package seal strength and integrity, and validated sterilization processes.
- Biological safety: conformity with biological evaluation principles (references to ISO 10993 series for cytotoxicity, implantation, sensitization, systemic toxicity).
- Radio‑opacity: requirements to enable postoperative imaging and device localization (radiopacity test methods referenced).
- Clinical evaluation and shelf life: requirements for clinical performance data and procedures to establish shelf life by real‑time or accelerated stability studies.
- Quality verification and sampling: lot definition, sampling plans and acceptance criteria (Annexes A & B) aligned with ISO 2859‑1 and ISO/TR 8550 for lot inspection.
Normative annexes (C–K) provide step‑by‑step test methods for dimensions, tensile tests, elastic memory, loading force, repeat loading, seal integrity and stability studies; Annex K covers test reporting.
Applications and who uses it
ISO 19351:2019 is used by:
- Manufacturers of fallopian rings for product design verification, production control and conformity assessment.
- Quality and regulatory teams preparing technical documentation, sterility validation, and shelf‑life claims.
- Testing laboratories performing mechanical, packaging and biocompatibility tests.
- Procurement agencies and hospitals selecting compliant products for permanent contraception programs.
- Notified bodies and regulators evaluating safety, labeling and clinical evidence for market approval.
Related standards
The standard references several key medical device standards for biological evaluation and sterilization, including:
ISO 19351:2019 provides a practical, test‑based framework to ensure fallopian rings meet safety, performance and packaging requirements expected by regulators, purchasers and clinical users.