WEBECO Hygiene in Medizin und Labor GmbH und Co. KG
A35SE1-2
Vers. 02 / 04.98
8
4.4 Standards and CE-Conformity
According to the EEC Medical Device Directive (MDD)
93/42/EEC the small steam sterilizer WEBECO A 35 - S is a
medical device and with reference to Annex IX of the MDD to
be classified as class IIa medical device.
WEBECO GmbH & Co. KG has established a quality
management system according to DIN EN ISO 9001 and DIN
EN 46001 which has been approved by a "Notified Body"
applying Annex II, article 3 of the MDD (reg. no. SY 9711455
01).
On this base the small steam sterilizer WEBECO A 35 - S has
been applied to a regular procedure for evaluation of
conformity and has been proved to be compliant with the
essential requirements of Annex I of the MDD. This allows the
sterilizer to be marked by the sign
A respective formal Declaration of Conformity has been duly
signed.
Conformity of the sterilizer type A 35 - S in accordance with
this instruction manual with the a.m. MDD 93/42/EEC also
includes compliance with the essential requirements of the
EEC-regulations as listed below:
•
73/23/EEC (Low Voltage Directive)
in conjunction with 93/68/EEC
•
89/336/EEC (EMC-Directive)
in conjunction with 92/31/EEC and
93/68/EEC
0197