RoHS

1

Hazardous Substances in RoHS

2

Lead (0,1 %)

Mercury (0,1 %)

Cadmium (0,01 %)

Hexavalent chromium (0,1 %)

Polybrominated biphenyls (PBB) (0,1 %)

Polybrominated diphenyl ethers (PBDE) (0,1

%)

Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)

Butyl benzyl phthalate (BBP) (0,1 %)

Dibutyl phthalate (DBP) (0,1 %)

Di isobutyl phthalate (DIBP) (0,1 %)

July, 2019

Medical, In-Vitro Monitoring and ControlJuly, 2021

The homogenous material

The 2 possible ways to demonstrate compliance to RoHS in Europe

Manufacturers options

4

RoHS

Directive

material

testing1

2

EN 50581

or

IEC 63000

Test

Report

TCF

EU DoC

Testing

Allowed standards:

IEC or EN 62321-series

5

Testing

6

Photo by Thermo Fisher

ICP_MS: Inductively Coupled Plasma Mass Spectrometry

And/Or

X-ray

Dismantling before testing

Standard:

EN 62321-2

7

1 hour later!

Test report

8

Send to wet analyzes or chemical judgement for non-pass measurements

Basic EN 50581 thinking-

Shit in-Shit out

9

Input-Material incl.

documentation

Your production

Ware-house

Production Package

Output-Product

Supplier Customer

Control Here

Take the BOM

10

Make Risk Assessment

11

1 2 2

22

2 3 3

3

Required doc from each supplier based on RISK

12

Build TCF

EN 50581/IEC 63000

Selected items

14

• 4 new substances into RoHS from July 22nd, 2019

• Scope expansion from July 2019.

• Update on exemptions

4 new substances into RoHS from July 2019

Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)

Butyl benzyl phthalate (BBP) (0,1 %)

Dibutyl phthalate (DBP) (0,1 %)

Di-isobutyl phthalate (DIBP) (0,1 %)

15

Consequences for Industry

Increased costs for Ban-free plastics

Increased costs for testing

Large maintenance job for updating all

technical files for RoHS

Updates of DoC’s

HAVE NOT STARTED???

16

Sorry-

Then it is too late

17

Introducing category 11 (catch all clause)

Removes discussions around- in scope or not. Like - are shoes with light inside or not ?

Carousels, Amusement park rides, USB...................

Covers veterinary and photovoltaic cells.

Scope expansion for RoHS –22 of July 2019

18

Renewal of exemptions for use of Lead:

- in copper alloy

- in cermet-based potentiometer and ceramic multilayer capacitors

-- lead in glass or ceramic

- in steel alloy

- in aluminum alloy

Exemptions update

19