Medicinal gases | Medical device gases | Other medical gases |
Explanation |
| A gas classified as a medicinal product (drug). Gases used in vivo to make a medical diagnosis or to restore, correct or modify physiological functions (physiologically active). | Other gases for medical uses not intended to be physiologically active, for example invasive use during surgery (in vivo) or for blood gas analyses (in vitro).
| Other gases for healthcare customers, where the intended use is not medicinal nor medical device. |
Product examples |
Oxygen, nitrous oxide,
nitric oxide, cardi-pulmonary test gases | Nitrogen - cryotherapy,
in vivo carbon dioxide - laparoscopy, in vivo
CO2/O2 – blood gas analyses, in vitro
| Helium - MRI (magnetic resonance imaging)
Calibration gases |
Directives/QS standards |
2001/83/EC Directive. Amended by 2004/27/EC Directive
75/318-319 EEC Regulatory
2003/94/EC Directive. 91/356/EEC GMP
(Good Manufacturing Practice)
94/25/EEC GDP (Good Distribution Practice)
2001/20/EC Directive and
2005/28/EC Directive (Good Clinical Practice)
EC/726/2004 Regulation (Community
procedures and EMEA)
European Pharmacopoeia | 93/42/EEC In vivo
medical devices
98/79/EEC In vitro
medical devices
European Pharmacopoeia
| ISO 13485 or QS reg requirements
Or other quality standards specified by the customer |