Appendix
8
Appendix
8.1 Technical data
Specification
Product class to (EU)
Medical Device Regulations
2017/745
Dimensions (W x H x D)
incl. non-vented retaining
ring and cap, for JOYCE
Dimensions (W x H x D)
incl. non-vented retaining
ring and cap, for LENA
Tube connection: Tapered
connection as per
EN ISO 5356-1 non-vented Ø 22 mm (female)
Cap
Size 1:
Size 2:
Standards applied
20
Product
IIa
50 mm x 60 mm x 75 mm
45 mm x 55 mm x 58 mm
Opening:
3.3 mm
4.8 mm
EN ISO 17510: 2020
Endoscope:
Ø 3.5 mm to 5 mm
Ø 5 mm to 6.5 mm