Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
CAN/CSA-Z18777-08 (R2018)
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
ICS code(s):
11.040.99
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

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 Internatinal 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.

Project need:

To review the Standard within the required 5 year period.

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