8.3 Compliance
MDD 93/42/EEC
EN 60601:1990, Amendment 1 (1991), Amendment 2 (1995)
EN 60601-1-2:2001
EN 60601-1-8:2004
EN ISO 21647:2004
EN ISO 5356-1:2004
EN 1789:2007
8.4 Classifications
According to the type of protection against electric shock
INTERNALLY POWERED EQUIPMENT (Battery power)
According to the degree of protection against electric shock
DEFIBRILLATION-PROOF TYPE BF APPLIED PART
According to the degree of protection provided by enclosures
IP33 (spray proof and tool proof EQUIPMENT)
According to the mode of operation
CONTINUOUS OPERATION
According to the degree of safety of application in the presence of a FLAMMABLE ANESTHETIC
MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE
EQUIPMENT not suitable for use in the presence of FLAMMABLE ANESTHETIC
MIXTURE WITH AIR; OR WITH OXYGEN OR NITROUS OXIDE
According to sterility
No part of EMMA is sterile.
30(32)