93/11/EEC - Release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers (Commission Directive)
Release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers (Commission Directive)
General Information
Frequently Asked Questions
An EU Directive is a legislative act of the European Union that sets out goals that all EU member states must achieve. However, it is up to each member state to devise their own laws on how to reach these goals through national transposition. Directives are used to harmonize laws across the EU, particularly for the functioning of the single market.
Directive 93/11/EEC covers "Release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers (Commission Directive)". There are 2 standards associated with this directive.
Harmonized standards under 93/11/EEC are European standards (ENs) developed by CEN, CENELEC, or ETSI in response to a mandate from the European Commission. When these standards are cited in the Official Journal of the European Union, products manufactured in conformity with them benefit from a presumption of conformity with the essential requirements of 93/11/EEC, facilitating CE marking and free movement within the European Economic Area.
ISO 7199:2009 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2009 also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.
- Standard25 pagesEnglish languagee-Library read for1 day
ISO 7199:2009 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2009 also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.
- Standard25 pagesEnglish languagee-Library read for1 day