ISO 8600-2:2015 内視鏡-医療用内視鏡および内視鏡装置- Part 2: 硬性気管支鏡の特定の要件 | ページ 2

Foreword

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The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 5, Microscopes and endoscopes.

This second edition cancels and replaces the first edition (ISO 8600-2:2002), of which it constitutes a minor revision.

ISO 8600 consists of the following parts, under the general title Endoscopes — Medical endoscopes and endoscopic accessories:

• Part 1: General requirements
• Part 2: Particular requirements for rigid bronchoscopes
• Part 3: Determination of field of view and direction of view of endoscopes with optics
• Part 4: Determination of maximum width of insertion portion
• Part 5: Determination of optical resolution of rigid endoscopes with optics
• Part 6: Vocabulary
• Part 7: Basic requirements for medical endoscopes of water-resistant type

Introduction

Rigid bronchoscopes need to serve three simultaneous functions during endoscopic procedures

• as an endoscope with distal illumination to allow visualization of the larynx, trachea and bronchi, and views into the bronchial trees,
• as a sheath for a flexible or rigid endoscope, aspirator (suction channel), biopsy forceps, scissors, etc., and
• as a gas passage (airway) for the terminal part of an anaesthesia ventilation system or the upper respiratory tract.

Rigid bronchoscopes, therefore, are to have sufficiently large channels with low gas-flow resistance and an adequate gas supply from the breathing system of an anaesthetic and/or breathing machine, or from compressed air/oxygen gas sources. Particular attention therefore is paid to the life-sustaining ventilatory aspects of this part of ISO 8600.

Ideally, all rigid bronchoscopes are to be usable to ventilate the patient whenever clinically necessary either under general anaesthesia or not, by means of a ventilation connector and an end-cap for assisted/controlled ventilation or by means of a jet-injector for intermittent jet ventilation. In addition to the general features of rigid bronchoscopes, the ventilatory aspects of both rigid ventilation bronchoscopes and rigid jet-ventilation bronchoscopes are especially included in this part of ISO 8600.

Test methods other than those specified in this part of ISO 8600, but of equal or greater accuracy, may be used to verify compliance with the given requirements. However, in the event of a dispute, the methods specified in this part of ISO 8600 are to be used as the reference methods.

A rationale for the most important requirements is given in Annex A. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this part of ISO 8600, but will expedite any subsequent revision.

1 Scope

This part of ISO 8600 specifies requirements for rigid bronchoscopes and their endoscopic accessories used in the practice of anaesthesia and medical endoscopy.

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 terms and definitions given in ISO 8600-1 and the following apply.

Bibliography