ISO 10079-1:2015 医療用吸引装置 — Part 1: 電動吸引装置 | ページ 2

Foreword

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The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use.

This third edition cancels and replaces the second edition (ISO 10079-1:1999), which has been technically revised.

ISO 10079 consists of the following parts, under the general title Medical suction equipment:

• Part 1: Electrically powered suction equipment
• Part 2: Manually powered suction equipment
• Part 3: Suction equipment powered from a vacuum or positive pressure gas source

Annex A forms a normative part of this part of ISO 10079 while Annex B, Annex C, and Annex D are for information only.

Annex B contains rationale statements for some of the requirements of this part of ISO 10079. The clauses and subclauses marked with an asterisk (*) at the beginning of the paragraph have corresponding rationale contained in Annex B included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated into this part of ISO 10079. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this part of ISO 10079, but will expedite any subsequent revisions.

Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.

1 Scope

This part of ISO 10079 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field and transport use.

This part of ISO 10079 does not apply to the following:

• a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;
• b) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
• c) syringes;
• d) dental suction equipment;
• e) anaesthetic gas scavenging systems;
• f) laboratory suction;
• g) autotransfusion systems;
• h) mucus extractors including neonatal mucus extractors;
• i) suction equipment where the collection container is downstream of the vacuum pump;
• j) ventouse (obstetric) equipment;
• k) suction equipment marked for endoscopic use only;
• l) plume evacuation systems.

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