ISO 10555-1:2023 カテーテル内の血管 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and catheters, 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 10555-1:2013), which has been technically revised. It also incorporates the amendment ISO 10555-1:2013/Amd 1:2017.

The main changes are as follows:

• added definitions for “inside diameter”, “gauge length”, and “coating” in Clause 3;
• added clarification on requirements (Clause 4) related to:
  • peak tensile force (revised the NOTE in Table 1);
  • leakage during pressurization: option for air pressure test (Annex I);
  • power injection burst pressure.

• added new requirements (Clause 4) related to:

  • risk approach;
  • usability engineering;
  • shelf life;
  • packaging system;
  • simulated use, kink and torque;
  • coating integrity, particulate;
  • distal tip stiffness.

• removed the requirements on side holes and distal tip;

• added text on “Nominal inside diameter for some applications” (Clause 5);

• added test details in the instructions for use for power injection (Clause 6);

• added reporting of maximum, minimum, standard deviation for variable data analysis in test reports;

• clarified “conditioning time” and “gauge length” (Annex B);

• clarified “minimum outside pressure requirement” (Annex D);

• introduced alternative test method using constant flowrate source (Annex G);

• replaced Figure H.1 in previous version with the new Table H.1;

• added new Annex I for alternative leakage under pressurization using air pressure;

• added new Annex J for rationale.