ISO 20698:2018 脊髄幹麻酔用カテーテルシステム—滅菌および単回使用のカテーテルおよび付属品 | ページ 2

参考文献

Foreword

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This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and catheters.

Introduction

International Standards covering catheter systems for neuraxial applications do not exist; nevertheless, this class of medical devices is very broad and counts several million catheters inserted or implanted per year. For many of these applications (e.g. the ones targeting the brain or the spine) there are considerable clinical risks.

Incorrect delivery route of medication and other misconnections between medical devices have resulted in a greater awareness of the potential role of incompatible connectors in reducing these incidents. Connectors for neuraxial applications are described in ISO 80369-6.

The development of a dedicated standard for neuraxial application is addressed in this document.

Guidance on transition periods for implementing the requirements of this document is given in ISO/TR 19244.

1 Scope

This document specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications.

This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate conformity with these requirements.

Catheters for neuraxial applications are intended to administer medications directly into neuraxial sites, to deliver wound infiltration analgesia and to other regional analgesia procedures or to monitor or remove fluids from neuraxial sites for therapeutic or diagnostic purposes.

This document is applicable to the following types of devices:

• spinal/epidural catheter systems;
• spinal/epidural port catheter systems;
• peripheral nerve block catheter systems;
• wound infusion catheter systems (also known as catheters for Surgical Site Continuous Analgesia).

This document is not applicable to:

• pumps and other devices intended to deliver medications through these catheter systems;
• catheters generically intended to administer substances into the body which are not intended to interact directly with the nervous system, but which have an indirect effect on nervous system (e.g. cannula needles);
• drainage catheters for any other application than neuraxial.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

3.10

risk assessment

overall process comprising a risk analysis and a risk evaluation

Figure 1 — Example of neuraxial catheter with identification of lengths and markings — Spinal/epidural port

[SOURCE: ISO 14971:2007, 2.18]
L1	effective length (3.4)
L2	total length (3.6)
L3	functional length (3.5)

Figure 2 — Example of neuraxial catheter with identification of lengths and markings — Wound infusion catheter

Key

L1	effective length (3.4)
L2	total length (3.6)
L3	functional length (3.5)