Routines for control of information regarding hazardous substances in the equipment
Level: Core
The purpose of the criteria is to secure that the supplier has routines and control systems for managing information on hazardous substances in the equipment and associated medical supplies.
Details
- Type:
- Qualification requirement
- ID:
- 10809:1
- Group:
- General criteria
Criterion text
The supplier must have routines for controlling and managing information on the presence of hazardous substances in the equipment and supplies covered by the contract. The routines shall secure that information regarding presence of hazardous substances in concentrations above 0.1% by weight shall systematically be requested from sub-suppliers. The subjects referred to are substances that are listed in:
- REACH-declaration Candidate List (article 59 in Declaration (EG) no. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals)
- REACH-declaration appendix XVII (restricted substances list, declaration g (EG) nr 1907/2006)
- RoHS Directive appendix II (2011/65/EU, on the restriction of the use of certain hazardous substances in electrical and electronic equipment).
- The medical device regulation (EU 2017/745), appendix 1, section 10.4.1.
The routines must also secure that the information above is available for the procurer.
Verification
Demonstrate routines according to the requirements above.
Proposed follow-up
Perform a control that routines are applied to the supplier, for example by random sample checks of documentation.
Motive
The legislation that is included in the criteria restricts the use of hazardous substances or demands that the supplier shall inform the purchaser about them.
Routines for control and information handling on hazardous substances facilitates the compliance with these laws. By extension, this means that there is less risk that hazardous substances will affect patients and healthcare personnel or disperse in the environment.
"BOM-check" is an example of a system that is used in the industry for managing information on the content of hazardous substances in the products.
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 10809:1
- Version date
- 2019-06-03