ISO 22413:2021 医薬品のトランスファーセット—要件とテスト方法 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This third edition cancels and replaces the second edition (ISO 22413:2010), which has been technically revised.

The main changes compared to the previous edition are as follows:

• the structure (moving all tests to the new Annex A) and partly the content were aligned with ISO 8536-4;
• Table 1 on penetration force was amended by a new entry;
• 6.7 (formerly 5.7) on fragmentation was clarified;
• former Clause 12 on storage was deleted;
• Clause 10 (formerly Clause 13) on labelling was updated;
• Clause 11 on the disposal has been added due to the single-use character of the product;
• former Annexes A and B on testing of fragmentation of transfer sets were moved to a new Annex A on physical tests;
• most of the tests in Annex A were, as far as necessary, aligned with the appropriate tests in ISO 8536-4;
• a new Clause A.9 on a test for stress cracking of small-bore connectors was added;
• Clause 2 and the Bibliography were updated.

Introduction

Transfer sets for pharmaceutical preparations transmit fluids from one container to another. The transfer sets mix fluids or dissolve dry substances and are used in combination with infusion and injection containers.

The transfer sets consist either of two piercing devices or of a piercing device in combination with a small-bore connector, which can be connected with each other in different ways. Transfer sets can have a housing.

Examples of different designs:

• a) two piercing devices connected to each other (similar to piercing devices of infusion containers);
• b) a metal cannula, bevelled on both sides or a combination of a) and b);
• c) metal cannulae, mostly having a hub or a grip plate in the middle, fixed to the plastic part;
• d) plastic piercing devices directly connected to a grip plate, or held by a tube at a distance to allow a higher hydrostatic pressure;
• e) piercing devices with an additional ventilation channel that can end in the other tip or outside;
• f) piercing devices with an air filter;
• g) piercing device in combination with a small-bore connector;
• h) piercing device in combination with a small-bore connector and a particle filter;
• i) piercing devices with housings serving, among other things, as a guide and a fixation on the connected containers for a secure, injury-free and contactless application.

1 Scope

This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

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:

Bibliography