BS EN ISO 7396-1:2016 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities for the following:

• oxygen;
• nitrous oxide;
• medical air;
• carbon dioxide;
• oxygen/nitrous oxide mixtures (see Note 1);
• helium/oxygen mixtures;
• (*) oxygen 93;
• gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above;
• air for driving surgical tools;
• nitrogen for driving surgical tools;
• vacuum.

NOTE 1 Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems.

NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396?2. This part of ISO 7396 includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas/vacuum systems.

This part of ISO 7396 specifies safety requirements for pipeline systems used in healthcare facilities, both public and private. It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to:

• acute care healthcare facilities;
• internal patient continuing care healthcare facilities;
• long-term care facilities;
• community-based providers;
• ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors' offices).

NOTE 3 This part of ISO 7396 may also be used as reference for pipeline systems for medical gases and vacuum intended to be installed in places other than healthcare facilities.


Cross References:
ISO 3746:2010
ISO 5359:2014
ISO 8573-1:2010
ISO 9170-1:2008
ISO 10524-2:2005
ISO 11197:2004
ISO 14644-1:1999
ISO 14971:2007
ISO 15001:2010
ISO 17672:2010
ISO 18082:2014
ISO 21969:2009
ISO 29463-1:2011
ISO 80601-2-69:2014
IEC 60601-1-8:2006
EN 286-1:1998
EN 1041:2008
EN 1254-1:1998
EN 1254-4:1998
EN 13348:2008
93/42/EEC
ISO 32:1977
ISO 407:2004
ISO 3746:2010
ISO 4126-1
ISO 4135
ISO 5145:2014
ISO 7183
ISO 7396-2
ISO/TR 7470
ISO 8359:1996
ISO 8573-2
ISO 8573-3
ISO 8573-4
ISO 8573-5
ISO 8573-6
ISO 8573-8
ISO 9001:2015
ISO 10083:2006
ISO 10524-4
ISO 13485:2003
ISO/TR 16142
AS 2896:1998
ASTM F1464
CAN/CSA-Z305.6-92
CGA E-10:2001
CGA P-8.1:1995
EN 475
EN 12021
ISO 13585:2012
EN 14931
EN 15908:2010
FD S 90-155
HTM 02/01:2006
NFPA 99
SIS/HB 370
2001/83/EC
91/356/EEC
ASSE 6000
CSA B-51
EN 13134
CSA Z7396.1-12
IEC 60601-1-2
ISO 11114-1
ISO 11114-2


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