ISO 1135-5:2015 医療用輸血装置—パート5：圧力注入装置で1回使用するための輸血セット | ページ 2

Foreword

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The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.

This first edition of ISO 1135-5, together with ISO 1135-4, cancels and replaces ISO 1135-4:2012, which has been technically revised with the following changes:

• the scope of ISO 1135-4 has been restricted to gravity feed applications, whereby, ISO 1135-5 is focused on pressure infusion applications;
• a new Annex D on ‘Storage volume’ has been added.

ISO 1135 consists of the following parts, under the general title Transfusion equipment for medical use:

• Part 3: Blood-taking sets for single use
• Part 4: Transfusion sets for single use, gravity feed
• Part 5: Transfusion sets for single use with pressure infusion apparatus

1 Scope

This part of ISO 1135 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment.

Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components.

Platelet components should not be transfused under pressure using these sets.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 1135.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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.

Bibliography