ISO 8669-3-1990 PDF

Full title and description

St ISO 8669-3-1990 — Urine collection bags — Part 3: Verification of rated volume. Specifies the method for verifying that a urine collection bag meets its declared (rated) nominal volume.

Abstract

This International Standard defines a verification procedure for the rated volume of urine collection bags. It gives a test method and basic acceptance considerations to ensure that bags labelled with a given capacity actually contain that capacity within specified tolerances. The document is a short procedural specification intended for manufacturers, test laboratories and conformity assessment bodies.

General information

• Status: Withdrawn / superseded.
• Publication date: November 1990 (First edition).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.180.20 (Aids for incontinence and ostomy).
• Edition / version: Edition 1 (ISO 8669-3:1990).
• Number of pages: 2.

Scope

Provides a reproducible test procedure for verification of the rated (declared) volume of disposable or reusable urine collection bags. The scope is limited to volume verification (filling and measurement procedures, test conditions and reporting) and does not cover other performance aspects such as leakage, materials, dimensions or biocompatibility.

Key topics and requirements

• Definition of rated volume and test specimen selection.
• Test filling procedure (fluid to use, fill rate and environmental conditions).
• Measurement method to determine actual contained volume and comparison with declared capacity.
• Acceptable tolerances / criteria for conformity (as specified in the short procedural text).
• Requirements for test equipment calibration and test documentation/reporting.
• Sampling and repeatability to ensure representative verification.

Typical use and users

Used by medical device manufacturers (production control and incoming materials verification), independent test laboratories, regulatory and conformity assessment bodies, hospital procurement and quality departments wanting to confirm that labelled bag capacities are accurate for clinical use.

Related standards

ISO 8669 series (urine collection bags) — notably ISO 8669-1 (vocabulary) and ISO 8669-2 (requirements and test methods, later edition). Other related documents include parts of the ISO 8670 series for ostomy collection bags and general medical-device test-method standards covering leakage, dimensions and materials.

Keywords

urine collection bag, rated volume, verification, capacity, test method, ISO 8669, incontinence aids, test procedure, medical device testing

FAQ

Q: What is this standard?

A: ISO 8669-3:1990 is an International Standard titled "Urine collection bags — Part 3: Verification of rated volume" that specifies a test method to verify the declared capacity of urine collection bags.

Q: What does it cover?

A: It covers the procedure for filling and measuring urine collection bags to confirm that their actual contained volume matches the rated (labelled) volume within specified tolerances. It does not address other performance characteristics such as leakage or materials compatibility.

Q: Who typically uses it?

A: Manufacturers, quality-control and production teams, independent testing laboratories, conformity assessment and regulatory bodies, and hospital procurement/clinical engineering staff.

Q: Is it current or superseded?

A: ISO 8669-3:1990 has been withdrawn. Relevant requirements and test methods for urine collection bags are covered in later parts of the ISO 8669 series (for example ISO 8669-2 published later). Users should consult the current ISO 8669 series or their national adoption to identify the active test-method requirements and any replacements.

Q: Is it part of a series?

A: Yes — it is part of the ISO 8669 series on urine collection bags (which includes parts for vocabulary, dimensions, verification of volume and leakage). The series is produced by ISO/TC 173 (aids for disabled or handicapped persons), subcommittee SC 3.

Q: What are the key keywords?

A: Urine collection bag, rated volume, verification, capacity, test method, ISO 8669, incontinence aids.