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ISO 20696:2018 PDF — Sterile urethral catheters for single use — GOST Standards

//ISO 20696:2018

ISO 20696:2018

Name: ISO 20696:2018 — Sterile urethral catheters for single use
SKU: ISO 20696:2018
Price: 59400 RUB
Availability: InStock

Sterile urethral catheters for single use

Название (английский):

ISO 20696:2018

Sterile urethral catheters for single use

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 33
Дата публикации:: 5 июня 2018 г.
Издание:: ISO IS 20696 edition 1 version 1
ICS:: 11.040.25

Тип поставки:

Full version59 400 ₽Read online 24h1 200 ₽Read online 72h1 800 ₽

Язык документа:

ruen

Срок поставки:6 раб. дн. (перевод)

Цена:59 400 ₽

Описание (английский):

This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon. This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents. NOTE Ureteral stents are covered in ASTM F1828‑97.

Abstract

Overview

Key topics and technical requirements

ISO 20696 defines both general and specific requirements and includes normative test methods (Annexes A–J). Major technical topics include:

Intended performance - device must safely and accurately access the intended anatomical location.
Risk management - application of an established process (e.g., ISO 14971) and maintenance of a risk management file.
Biocompatibility - evaluation in accordance with ISO 10993‑1 to ensure absence of biological hazard.
Detectability - catheter (or effective length) should be detectable by X‑ray or other imaging if required by risk assessment.
Surface finish - external effective length must be free from extraneous matter and process defects; inspection criteria defined.
Size designation - outer diameter expressed in millimetres (rounded up to 0.1 mm) with tolerances (±0.33 mm); balloon capacity in mL; effective shaft length reporting.
MRI compatibility, connectors, sterilization - general requirements for safe use and compatibility with clinical environments.
Specific mechanical and functional tests - strength, connector and balloon security, inflation lumen integrity, balloon volume maintenance (compliant vs non‑compliant balloons), flow rate, corrosion resistance, kink stability, peak tensile force, and inflated balloon resistance to traction.
Labelling and IFU - mandatory markings and instructions for use to support safe application.

Annexes provide test methods for each performance requirement (e.g., flow rate, kink stability, balloon deflation reliability).

Applications and users

ISO 20696 is intended for:

Medical device manufacturers designing and producing single‑use sterile urethral catheters
Regulatory and quality engineers preparing technical documentation and compliance evidence
Clinical procurement specialists and hospitals verifying device safety and specifications
Test laboratories performing conformity and performance testing

This standard supports product development, regulatory submissions, quality control and clinical risk assessments.

Related standards

ISO 20697 - Sterile drainage catheters for single use (different catheter types)
ASTM F1828‑97 - Ureteral stents
ISO 14971 - Risk management for medical devices
ISO 10993‑1 - Biological evaluation of medical devices
ISO 14155 - Clinical investigation of medical devices
ISO 15223‑1, ISO 80369‑1 - Labelling and connector standards
ISO/TR 19244 - Guidance on transition periods for ISO/TC 84 standards

Keywords: ISO 20696, sterile urethral catheters, single‑use catheters, catheter test methods, biocompatibility, risk management, medical device standards.

Технические детали

Технический комитет: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO 20696:2018

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ISO 20696:2018

Abstract

Overview

Похожие стандарты

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 20697:2018

Sterile drainage catheters and accessory devices for single use

BS EN ISO 20696:2018

Sterile urethral catheters for single use.

BS EN ISO 14971:2019+A11:2021

Medical devices. Application of risk management to medical devices.

BS EN ISO 10993-14:2009

Biological evaluation of medical devices. Identification and quantification of degradation products from cera…

BS EN ISO 14155:2026-TC

Tracked Changes. Clinical investigation of medical devices for human subjects. Good clinical practice.

BS EN ISO 15223-1:2021(CD-ROM+PDF)

Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Gen…

BS EN ISO 80369-1:2026 - TC

Small-bore connectors for liquids and gases in healthcare applications - General requirements

PD ISO/TR 19244:2014

Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal…