ISO 15883-7:2016 洗浄消毒器—パート7：非侵襲的で重要ではない熱不安定性医療機器および医療機器に化学消毒を採用する洗浄消毒器の要件とテスト | 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 ).

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ISO 15883-7 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 102, Sterilizers for medical purposes, in collaboration with Technical Committee ISO/TC 198, Sterilization of health care products, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

ISO 15883 consists of the following parts, under the general title Washer-disinfectors:

• Part 1: General requirements, terms and definitions and tests
• Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
• Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
• Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
• Part 5: Test soils and methods for demonstrating cleaning efficacy [Technical Specification]
• Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
• Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment

Introduction

It is intended that this introduction is to be read in conjunction with the introduction to ISO 15883-1.

This part of ISO 15883 is the seventh of a series specifying the performance of washer-disinfectors. It specifies the particular requirements for performance applicable to washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices, and healthcare equipment. Its requirements apply to washer-disinfectors used for cleaning and disinfection of thermolabile equipment for use without further treatment in healthcare settings. Such reusable equipment needs to be cleaned and disinfected, but processing in a washer-disinfector for surgical instruments (see ISO 15883-2), for human waste containers (see ISO 15883-3), for endoscopes (see ISO 15883-4), or for non-invasive, non-critical medical devices, and healthcare equipment employing thermal disinfection (see ISO 15883-6) is inappropriate and/or impractical. Examples of such equipment are bedsteads and bedside furniture, trolleys and transport carts, operating tables, footwear, wheelchairs, or aids for the disabled.

Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883.

In respect to any potential adverse effects on the quality of water intended for human consumption caused by use of the washer-disinfector, it is noteworthy that

• a) until verifiable international criteria are adopted, the existing national regulations concerning the use and/or characteristics of the washer-disinfector remain in force (e.g. the requirement of backflow prevention), and
• b) the ISO 15883 series of standards provides no information as to whether the washer-disinfector may be used without restriction in any of the ISO member states.

1 Scope

This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following:

• a) bedframes;
• b) bedside tables;
• c) transport carts;
• d) containers;
• e) surgical tables;
• f) sterilization containers;
• g) surgical clogs;
• h) wheelchairs, aids for the disabled.

This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.

Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do not fall within the scope of this part of ISO 15883.

In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs.

The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.

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 15883-1, ISO 15883-4, and ISO 15883-6 apply.

Bibliography