CSA Z18777:08 (R2023)

CSA Preface

This is the first edition of CAN/CSA-Z18777, Transportable liquid oxygen systems for medical use - Particular requirements, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 18777 (first edition, 2005-02-15).

This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Respiratory Technology, under the jurisdiction of the CSA Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.

Scope

IEC 60601-1:1988, Clause 1, applies except as follows:

Amendments (add at end of 1.1):

1.1

This International Standard specifies requirements for the safety and essential performance of transportable liquid oxygen systems which are used as a supply source for oxygen therapy. These devices usually consist of a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portable unit. These devices are mostly used in home care applications and in health care facilities/institutions. These devices are often used without professional supervision.

Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from this International Standard.

The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:1998 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

1.4

Addition:

NOTE Planning and design of products complying with this International Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.