ISO 8536-8-2015 PDF

Full title and description

Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus. This International Standard specifies requirements and information for sterilized infusion sets intended for single use with pressure infusion apparatus operating up to a maximum of 200 kPa (2 bar).

Abstract

ISO 8536-8:2015 gives users information on sterilized infusion sets for single use designed to be used with pressure infusion apparatus (maximum 200 kPa / 2 bar). It covers essential characteristics, identification, labelling and performance considerations intended to support safe use and regulatory compliance for such disposable infusion sets.

General information

• Status: Published (International Standard; under review/revision stage noted by ISO).
• Publication date: June 2015 (ISO edition 2, published June 2015).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.20 (Infusion, transfusion and dialysis equipment).
• Edition / version: Edition 2 (2015).
• Number of pages: 13 (ISO published document length).

Scope

This part of ISO 8536 applies to sterilized infusion sets for single use that are intended for use with pressure infusion apparatus up to a maximum working pressure of 200 kPa (2 bar). It provides information on design, performance and labelling relevant to safe use and compatibility with pressure infusion systems; it does not override legally binding national pharmacopoeia or regulations where those apply.

Key topics and requirements

• Definitions and classification of infusion sets for pressure infusion apparatus.
• Maximum working pressure and performance parameters (specified for up to 200 kPa / 2 bar).
• Materials and sterilization—requirements to ensure sterility, biocompatibility and packaging integrity for single-use devices.
• Design features and connectors—requirements to ensure compatibility with pressure infusion apparatus and to reduce misconnections.
• Labelling and instructions for use—mandatory identification, intended use, pressure rating, lot/sterilization details and safety information.
• Performance and testing—tests and inspection criteria to verify leak tightness, flow characteristics and pressure resistance.
• Information on limitations of use and warnings relevant to clinical practice and regulatory compliance.

Typical use and users

Used by medical device manufacturers (design, production and quality), regulatory affairs teams, hospital procurement and clinical engineering, healthcare providers (to understand device limitations and labelling), and conformity assessment bodies assessing compliance with ISO and national requirements for disposable infusion sets used with pressure infusion equipment.

Related standards

ISO 8536 is a multipart series covering infusion, transfusion and dialysis equipment; related parts include ISO 8536‑1, ISO 8536‑2, ISO 8536‑3, ISO 8536‑4, ISO 8536‑9 and ISO 8536‑10 among others that address different types of infusion sets, fluid lines and accessories. ISO has recorded work to revise or replace part 8 (an Approved Work Item is under development). National/adopted versions (EN, DIN, ČSN, ÖNORM etc.) exist for regional use.

Keywords

infusion set, pressure infusion apparatus, single-use, sterilized infusion set, 200 kPa, medical device, labelling, connectors, ISO 8536, infusion equipment

FAQ

Q: What is this standard?

A: ISO 8536-8:2015 is an International Standard that specifies information and requirements for sterilized single‑use infusion sets intended for use with pressure infusion apparatus up to 200 kPa (2 bar).

Q: What does it cover?

A: It covers design-related information, performance characteristics, materials/sterilization considerations, labelling and testing relevant to single‑use infusion sets used with pressure infusion equipment; it is not a substitute for mandatory national regulations or pharmacopoeial requirements.

Q: Who typically uses it?

A: Device manufacturers, regulatory and quality professionals, conformity assessment bodies, hospital procurement and clinical engineering groups, and clinicians who need to understand device limitations and labelling.

Q: Is it current or superseded?

A: The document ISO 8536-8:2015 was published in June 2015 (Edition 2) and remains the published International Standard; ISO records indicate the standard is scheduled for review and an Approved Work Item for a revision/replacement (ISO/AWI 8536-8) is under development. Users should check the issuing ISO catalogue or their national standards body for the absolute current status before relying on it for regulatory decisions.

Q: Is it part of a series?

A: Yes — ISO 8536 is a multipart series addressing infusion, transfusion and dialysis equipment; Part 8 specifically concerns single‑use infusion sets for pressure infusion apparatus and other parts cover different infusion equipment, fluid lines and accessories.

Q: What are the key keywords?

A: Infusion set; pressure infusion apparatus; single-use; sterilized; 200 kPa; medical device; labelling; connectors; ISO 8536.