ISO 1135-3:2016 医療用輸血装置—パート3：使い捨て用採血セット | 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 second edition cancels and replaces the first edition (ISO 1135-3:1986), which has been technically revised with the following changes:

• part title has been amended by “for single use” in alignment with the other parts of ISO 1135;
• figures have been updated;
• subclause 3.6, “Designation examples” has been deleted;
• physical, chemical and biological requirements have been aligned with ISO 1135-4;
• Clause 10, “Disposal” has been added;
• Annexes A, B and C have been aligned with ISO 1135-4;
• all references have been updated.

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 types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.

This part of ISO 1135 also aims to provide

• a) specifications relating to the quality and performance of materials used in transfusion equipment, and
• b) a unified presentation of terms for such equipment.

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.

Bibliography