ISO 15002:2008 医療用ガスパイプラインシステムのターミナルユニットに接続するための流量計測装置 | ページ 2

1.1この国際規格は、以下に適用されます。

• 直接または柔軟な接続アセンブリによって接続され、医療ガスの流量調整、測定、および供給のために医療ガスパイプラインシステムのターミナルユニットでオペレータによって切断される流量測定デバイス;
• 圧力調整器などのデバイスのガス固有の接続ポイントでオペレータによって接続および切断される流量計測デバイス。

1.2この国際規格は、以下に適用されます。

• a)以下の医療用ガスでの使用を意図した流量計測装置:
  • 空気;
  • 亜酸化窒素;
  • 医療用空気;
  • 二酸化炭素;
  • 酸素/亜酸化窒素混合物 [50%/50% (体積)];
  • 上記のガスの特定の混合物;

• b)次のガスで使用することを意図した流量計測装置:

  • 酸素富化空気;
  • ヘリウム;
  • キセノン。

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 15002 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems.

This second edition cancels and replaces the first edition (ISO 15002:2000) which has been technically revised.

Introduction

Flow-metering devices are widely used for delivery of medical gases supplied by a medical gas supply system directly to a patient. These devices need to deliver accurate flows under varying conditions of temperature and inlet pressure. Therefore it is important that the operating characteristics be specified and tested in a defined manner.

This International Standard pays particular attention to:

• safety (mechanical strength, safe relief of excess pressure, resistance to ignition);
• gas specificity;
• cleanliness;
• suitability of materials;
• accuracy;
• testing;
• identification;
• information supplied.

Annex A contains rationale statements for some of the requirements of this International Standard. The clauses and subclauses marked with an asterix (*) after their number have corresponding rationale contained in informative Annex A, included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this International Standard. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this International Standard, but will expedite any subsequent revisions.

1 Scope

1.3 This International Standard does not apply to electrical or electronic flow-metering devices.

1.4 This International Standard does not apply to gases used for driving surgical tools.

2 *Normative references

The following referenced documents are indispensable for the application 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.

Bibliography