ISO 8669-2-1996 PDF

Full title and description

St ISO 8669-2-1996 — Urine collection bags — Part 2: Requirements and test methods. This international standard specifies performance requirements and standardized test methods for body‑worn and non‑body‑worn open and closed urine collection bags (excluding paediatric urine bags).

Abstract

ISO 8669-2:1996 defines required performance characteristics and laboratory test procedures for urine collection bags, including determinations of test volume, absence of leakage, and other functional tests under controlled conditions. It consolidates and replaces earlier part‑specific documents in the ISO 8669 series and is intended to ensure product safety, performance and interchangeability for clinical and care settings.

General information

• Status: Published — confirmed (current edition as of confirmation actions recorded in 2023).
• Publication date: December 1996 (Edition 2).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.180.20 — Aids for incontinence and ostomy.
• Edition / version: Edition 2 (ISO 8669-2:1996).
• Number of pages: 15 pages (official ISO record).

Scope

The standard gives performance requirements and test methods for both body‑worn and non‑body‑worn urine collection bags (open‑ended and closed systems). It excludes urine bags intended specifically for paediatric use. ISO 8669-2:1996 replaces earlier editions/parts addressing dimensions, rated volume verification and freedom‑from‑leakage which were withdrawn when this edition was published.

Key topics and requirements

• Specification of test volume and standard procedure for measuring bag capacity (filling with water under defined hydrostatic head and measuring the contained volume).
• Leakage testing under no‑load and loaded conditions using coloured water to detect external leakage.
• Standardized test conditions (e.g., test temperature ~23 °C ±2 °C) and sample conditioning prior to testing.
• Requirements for dimensional measurements (when dimensions are given) and reference to annexed measurement methods.
• Performance and safety attributes relevant to clinical use (connectors, anti‑reflux features and sample ports are addressed by testable performance criteria rather than prescriptive designs).

Typical use and users

Primary users include medical device manufacturers (design and quality teams) who need to design, test and declare conformity for urine collection bags; hospital and clinical procurement and sterile supply departments who specify products for patient use; testing laboratories performing conformity and routine QA testing; and regulatory bodies reviewing device performance claims. Manufacturers commonly cite compliance with ISO 8669-2 when marketing clinical‑grade urine bags.

Related standards

ISO 8669 is a multi‑part series; related documents include ISO 8669-1 (vocabulary) and earlier parts (3 and 4) that were withdrawn or superseded when the 1996 edition of part 2 was published. Other nearby standards of interest include standards for ostomy collection bags (e.g., ISO 8670‑2) and related product‑specific test standards and regional/adopted versions (EN/ISO adoptions).

Keywords

Urine collection bag, urine bag, test methods, leakage testing, test volume, medical device, ISO 8669, incontinence aids, performance requirements, body‑worn, non‑body‑worn.

FAQ

Q: What is this standard?

A: ISO 8669-2:1996 is an international standard that specifies performance requirements and laboratory test methods for urine collection bags intended for adult clinical and care use.

Q: What does it cover?

A: It covers test methods (volume determination, leakage tests and related procedures), required test conditions (for example temperature and sample conditioning), and performance criteria for body‑worn and non‑body‑worn urine collection bags. It does not apply to paediatric urine bags.

Q: Who typically uses it?

A: Device manufacturers, quality and R&D teams, independent test laboratories, hospital procurement and regulatory reviewers rely on the standard to design, test and verify urine bag performance. Manufacturers often reference compliance with ISO 8669-2 on product documentation.

Q: Is it current or superseded?

A: The 1996 edition (Edition 2) is the published edition and has been confirmed in ISO review actions (confirmation activity recorded in 2023). Earlier ISO 8669 parts/editions addressing dimensions and specific tests were withdrawn and consolidated into this edition. Users should check with their national standards body or ISO for the very latest status or any subsequent revisions.

Q: Is it part of a series?

A: Yes — ISO 8669 is a series covering urine collection bags (part 1 vocabulary; part 2 requirements and test methods; earlier parts 3 and 4 were withdrawn/replaced when part 2 (1996) was published). The series sits under ICS 11.180.20 (aids for incontinence and ostomy).

Q: What are the key keywords?

A: Urine collection bag, test methods, leakage, volume determination, body‑worn, non‑body‑worn, ISO 8669‑2.