ISO 11197:2019 医療用品ユニット | ページ 2

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.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives ).

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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents ).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html .

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

This fourth edition cancels and replaces the third edition (ISO 11197:2016), which has been technically revised. The main changes compared to the previous edition are as follows:

• editorial revision;
• change in the requirements defining the inclusion of USB outlets within medical supply units;
• addition of methods of internal cabling connections and specific tests including but not limited to impact resistance.

Introduction

Many healthcare facilities use surface-mounted or recessed containment systems and enclosures for accommodating and displaying essential patient care services. These are known as medical supply units.

This document specifies requirements for medical supply units manufactured in factories or assembled from components on site.

It is intended for use by those persons involved in the design, construction, inspection, testing, maintenance and operation of healthcare facilities as well as those manufacturing, assembling and installing medical supply units.

Persons involved in the design, manufacture, installation, maintenance and testing of equipment intended to be connected to gas for medicinal use, medical device gas, vacuum, anaesthetic gas scavenging and/or plume extraction systems should be aware of the contents of this document.

This document is a particular standard, based on IEC 60601-1:2005+A1:2012. IEC 60601-1:2005+A1:2012 is the basic standard for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment; it also contains certain requirements for reliable operation to ensure safety.

IEC 60601-1:2005+A1:2012 has associated collateral standards and particular standards. The collateral standards include requirements for specific technologies and/or hazards and apply to all applicable equipment, such as medical systems, electromagnetic compatibility (EMC), radiation protection in diagnostic X-ray equipment, software, etc. The particular standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc.

For an explanation of the special numbering in this document and more on the terms “collateral”, “particular” and “general” standards, see 201.1.3, 201.1.3.1, 201.1.3.2.

Annex AA contains rationale statements for some of the requirements of this document. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this document. The clauses and subclauses marked with (*) after their number have a corresponding rationale contained in Annex AA.

In this document, the following print types are used:

• requirements, compliance with which can be verified, and definitions: roman type;
• informative material appearing outside of tables, such as notes, examples and references: in smaller roman type. Normative text of tables is also in a smaller roman type;
• test methods: italic type;
• terms defined in clause 3 of the general standard, in this document or as noted: italic type.

Bibliography