ISO 8536-13:2016

Name: ISO 8536-13:2016 — Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact
SKU: ISO 8536-13:2016
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Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact

Название (английский):

ISO 8536-13:2016

Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 6
Дата публикации:: 27 сентября 2016 г.
Издание:: ISO IS 8536 edition 1 version 1
ICS:: 11.040.20

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Описание (английский):

ISO 8536-13:2016 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 8536-13:2016 - "Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact" specifies requirements for non-sterile, single‑use graduated flow regulators (GFRs) used as subcomponents in sterilized, gravity‑feed infusion sets. The standard covers design, materials, physical, chemical and biological requirements, packaging and labelling, and normative test methods to demonstrate performance and safety. Note: national pharmacopoeia or regulations may take legal precedence in some countries.

Key topics and requirements

Scope and purpose

Applies to gravity‑feed GFRs that have direct fluid contact and regulate intravenous infusion flow.

Design

GFRs shall provide constant flow regulation, prevent accidental flow changes, and clearly indicate open and off (closed) positions.

Materials and biological safety

Materials must meet chemical/biological requirements and be evaluated per ISO 10993‑1 (biological evaluation of medical devices).

Physical performance

Graduated scale: must show at minimum open/closed and manufacturer‑defined scale positions.
Particulate contamination: inner surfaces must be smooth; particle counts must not exceed the contamination index (see Annex A.1).
Tensile strength: withstand a static longitudinal tensile force of ≥15 N for 15 s (Annex A.2).
Leakage: impermeable to microorganisms/fluids; no air leakage when tested at 50 kPa excess pressure and 40 ±1 °C (Annex A.3).
Flow rates and stability: measured with NaCl 9 g/L at 23 ±2 °C, hydrostatic head 1 m; accuracy per manufacturer and stability within ±10% over a 6‑hour test after 15 min stabilization (Annex A.4).

Packaging and labelling

Referenced to ISO 8536‑4 requirements; labelling must additionally reference GFR.

Applications and users

Who uses this standard

Medical device designers and manufacturers of infusion sets and GFR components
Quality assurance / regulatory teams validating product design and batch release
Test laboratories performing physical and performance testing
Procurement and clinical engineering evaluating device compliance

Practical applications

Design validation and type testing for single‑use GFRs
Production control specifications (material selection, particulate limits, tensile/ leak targets)
Regulatory submissions and conformity assessments where ISO 8536 series is referenced
Supplier contracts and acceptance criteria for infusion set subcomponents

Related standards

ISO 8536 family (Parts 1–12, 14) - infusion equipment series

ISO 8536‑4 - infusion sets for single use, gravity feed (normative references for packaging, labelling, tests)

ISO 10993‑1 - biological evaluation of medical devices

ISO 15223‑1 (symbols for labelling) - referenced for label content

Keywords: ISO 8536-13, graduated flow regulators, infusion equipment, single‑use GFR, gravity feed, medical device standard, flow rate testing, leakage test, particulate contamination, ISO 10993-1.

ISO 8536-13:2016

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and users

Related standards

Технические детали

ISO 10993-12:2012

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 8536-4:2019

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

ISO 8536-15:2022

Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use

ISO 15223-1:2016

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