IS/ISO 15001 : 2010 Anaesthetic and Respiratory Equipment - Compatibility with Oxygen

ICS 11.040.10

MHD 11

Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (First Revision) which is identical with ISO 15001 : 2010 ‘Anaesthetic and respiratory equipment - Compatibility with oxygen’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Anaesthetic, Resuscitation and Allied Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 2009 which was identical with ISO 15001 : 2003 ‘Anaesthetic and respiratory equipment - Compatibility with oxygen’. This first revision has been undertaken to align it with the latest edition of ISO 15001 : 2010.

Oxygen, pure or mixed with other medical gases, is widely used in medical applications. Because patients and clinical personnel are often in close proximity to devices used with oxygen, the risk of serious injury is high if a fire occurs in an oxygen-enriched atmosphere. A common cause of fire is the heat produced by adiabatic compression, and the presence of hydrocarbon and particulate contaminants facilitates ignition. Some combustion products, especially some non-metals (for example plastics, elastomers and lubricants) are toxic and thus patients remote from that equipment and who are receiving oxygen from a medical gas pipeline system might be injured when a problem occurs. Other equipment which is in close proximity to the equipment using oxygen, or that utilizes oxygen as its source of power, can be damaged or fail to function properly if there is a problem with the oxygen equipment.

Reduction or avoidance of these risks depends on the choice of appropriate materials, cleaning procedures and correct design and construction of equipment so that it is compatible with oxygen under the conditions of use. This standard gives recommendations for the selection of materials and the cleaning of components made from them, for use in oxygen and oxygen-enriched atmospheres.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are however not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.