Weight Of Devices And Stainless Steel Materials; Applied Directives And Standards - Smeg BPW1260 User Manual

Bedpan washers – hospital sector
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15.1.4 WEIGHT OF DEVICES AND STAINLESS STEEL MATERIALS

[Values in kg]

15.1.5 APPLIED DIRECTIVES AND STANDARDS

- Regulation (EU) 2017/745 – New Medical Device Regulation
- European directive 2014/35/EU [Safety]
- European directive 2014/30/EU [EMC]
- 2011/65/UE including delegated directive (EU) 2015/863
The following standards are applied to the product:
UNI EN ISO 15883-1:2014 (EN ISO 15883-1:2009 + A1:2014), EN ISO 15883-3:2009, UNI
EN ISO 15883-5:2021
UNI CEI EN ISO 14971:2022 [EN ISO 14971:2019, EN ISO 14971:2019/A11:2021]
EN 62304:2006 + A1:2015
EN 62366-1:2015
EN 61010-1:2010 /A1:2019/AC:2019-04, EN 61010-1:2010/A1:2019
EN IEC 61010-2-040:2021
EN IEC 61326-1:2021
EN IEC 63000:2018
EN 15223-1:2021
The following standards are applied to the system:
EN ISO 13485:2016 + A11:2021
User Manual
Weight when empty [no load in
device]
Weight when packed
Maximum weight in use
[+10 kg max load+11 litres of water intake]
[+10 kg, detergent jerry cans]
Max load on floor
Washing chamber
External panelling
193909105 rev.02
102
109
133
2
493 kg/m
AISI 304 / AISI 316L
[Depending on model]
AISI 304
BPW1260
Page 85 – 93

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