ISO 8536-10-2015 PDF

Full title and description

Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment. This standard specifies requirements for sterilized single‑use accessories used in fluid lines with pressure infusion equipment, including two‑way, three‑way and four‑way stopcocks and manifolds, units with injection sites or check valves, and stoppers or adapters.

Abstract

ISO 8536-10:2015 establishes functional, dimensional and safety requirements and basic test criteria for accessories intended for single use in fluid lines used with pressure infusion apparatus. The standard addresses device types, sterility considerations, mechanical performance, leakage and connection compatibility (including conical Luer fittings), and tests relevant to particulate and biological safety.

General information

• Status: Published.
• Publication date: June 2015 (Edition 2, published 10 June 2015).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.20 (Transfusion, infusion and injection equipment).
• Edition / version: Edition 2 (2015).
• Number of pages: 8 pages.

Scope

Applies to sterilized accessories for single use in fluid lines for use with pressure infusion equipment as specified in ISO 8536‑8. Devices covered include stopcocks (two‑, three‑ and four‑way and manifolds), units with injection sites or check valves, and stoppers or adapters; the standard defines performance and safety tests and references related biological and connector standards.

Key topics and requirements

• Scope of items: two‑way, three‑way, four‑way stopcocks and manifolds; injection‑site or check‑valve units; stoppers and adapters for single use.
• Sterility and biological safety: requirements and references for sterility, freedom from pyrogens and interaction with blood (references include ISO 10993‑4).
• Mechanical performance: tensile strength and connection integrity tests (e.g., specified static tensile loads and leak tightness requirements).
• Fluidic performance and contamination control: limits and test methods for air bubble avoidance, particulate contamination and rinsing procedures.
• Connector compatibility: conical (Luer) fittings and other adapters to comply with ISO 594‑2 and related connector standards.

Typical use and users

Manufacturers of infusion accessories and medical device suppliers use this standard to design and test single‑use pressure‑infusion accessories. Regulatory bodies, hospital procurement, clinical engineers and quality teams reference it for conformity assessment, device specification and acceptance testing. It is also used by laboratories performing bench testing of infusion‑line components.

Related standards

Part of the ISO 8536 series addressing infusion equipment. Closely related parts include ISO 8536‑4, ISO 8536‑5, ISO 8536‑8, ISO 8536‑9, ISO 8536‑11 and ISO 8536‑12, plus connector and biological evaluation standards such as ISO 594‑2 (Luer fittings) and ISO 10993 series.

Keywords

infusion accessories; stopcock; manifold; pressure infusion equipment; single‑use; sterile accessories; Luer; connector compatibility; leakage test; particulate control.

FAQ

Q: What is this standard?

A: ISO 8536‑10:2015 is an international standard that specifies requirements for sterilized, single‑use accessories for fluid lines used with pressure infusion equipment, such as stopcocks, manifolds, injection sites, stoppers and adapters.

Q: What does it cover?

A: It covers the types of accessories listed above and establishes performance, dimensional and safety requirements and test methods (mechanical, leakage, particulate and biological considerations) and references relevant connector and bioevaluation standards.

Q: Who typically uses it?

A: Device manufacturers, test laboratories, regulatory authorities, hospital procurement and clinical engineering teams use it for design, testing, conformity assessment and purchasing specifications.

Q: Is it current or superseded?

A: The 2015 edition (Edition 2) is the current published edition, which replaced the earlier 2004 edition.

Q: Is it part of a series?

A: Yes. ISO 8536‑10:2015 is one part of the ISO 8536 series on infusion equipment; other parts address infusion sets, burette sets, fluid lines, filters, check valves and related components.

Q: What are the key keywords?

A: Infusion accessories, stopcocks, manifolds, pressure infusion, single‑use, sterile, Luer, leakage testing, particulate control.