RESTRICTED
WORLD TRADE G/TBT/Notif.95.63
8March 1995
ORGANIZATION
(95-0501)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Food andDrug Administration (5)
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Infant apnea monitor
5. Title andnumber ofpages ofthenotified document: Performance Standard forthe
Infant Apnea Monitor (10pages)
6. Description ofcontent: TheAdministration isproposing aregulation toestablish a
mandatory performance standard forInfant Apnea Monitors, which areasubset of
breathing frequency monitors alsocalled Neonatal Apnea Monitors. TheInfant Apnea
Monitor isasystem intended foruseoninfants todetect cessation ofbreathing.
7. Objective andrationale: Toensure thatInfant Apnea Monitors accurately andreliably
detect theabsence ofeffective respiration andprovide analarm insuch cases and
establish performance requirements andtestmethods thatwillprovide reasonable
assurance ofthesafety andeffectiveness oftheInfant Apnea Monitor.
8. Relevant documents: 60FR9762, 21February 1995; 21CFR Part896. Willappear
intheFederal Register when adopted.
9. Proposed dateofadoption andentry intoforce: Theagency isproposing thatanyfinal
ruletheymayissue based upon thisproposal become effective oneyearfollowing its
publication intheFederal Register.
10. Final dateforcomments: 22May1995
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: