Legal Framework DEN-S-NET
Legal Framework
Revision History
Author | Date | Change Description | Approved by |
|---|---|---|---|
L. van Noort |
| Document Creation |
|
Scope
Manufacturer | Novanta Technologies Spain S.L. C\ Àvila 124 2B, 08018, Barcelona, Spain |
|---|---|
Authorized Representative*: *An Authorized Representative is required for CE marking directives/regulations when the Manufacturer is located outside of the EU | N/A |
Product Description: | Denali Safe NET |
Part Number: | DEN-S-NET-xx rev. B (With X is 0-99, A-ZZ to describe firmware version, finished good revision numbers may vary for different/custom firmware versions) |
Geographical Target Markets* *Compliance is evaluated against target markets. Product may be sold outside of target market, in which case requirements should be evaluated on a case-by-case basis. ISO 3166-1 alpha-3 codes are used unless accompanied by full definition. | European Economic Area (EEA), TUR, USA, CAN, MEX, GBR, IND, CHN, JPN, TWN, KOR, ISR |
Introduction
This document sets out to identify the directives, regulations and voluntary normative requirements that apply to the product family mentioned under the document Scope. For a full description of the product, see the formal product descriptions [1-3], and the controlled product Bills of Materials (BOMs), drawings and schematics in Arena [4-6].
Applicable Regulatory Requirements
The product mentioned in the Scope of this document, is subject to the following CE-marking directives/regulations, sufficient for sale in the EEA (direct implementation of CE marking), TUR (under joint Customs Union), GBR (indefinite acceptance of CE marking in lieu of UKCA marking) and ISR (under the “What’s good for Europe is good for Israel” Reform):
The Machinery Directive (2006/42/EC) [7] - The Denali Safe NET servo drives fall under the Machinery Directive in their capacity as safety components. The servo drives contain logic to ensure safety functions which, under list item 21 of the Annex IV List of the Machinery Directive (2006/42/EU), requires them to obtain EC Type-approval from a notified body. The safety function can be used in safety applications up to:
SIL3 (IEC 61800-5-2/IEC 61508)
SILCL3 (IEC 62061)
CAT.3 / PLe (EN ISO 13849-1)
The Low Voltage Directive (2014/35/EU) [8] - The Denali Safe NET servo drives fall under the Low Voltage Directive in their capacity as electrical components and shall meet the essential requirements associated. However, due to mutual exclusivity with the Machinery Directive, as defined in the Guide to application of the Machinery Directive 2006/42/EU, Edition 2.3., §63, conformity shall not be declared to the Low Voltage Directive.
The EMC Directive (2014/30/EU) [9] - The Denali Safe NET servo drives fall under the EMC Directive in their capacity as apparatus. Since, per Article 3.2(1) of Directive 2014/30/EU, components or subassemblies intended for incorporation into an apparatus by the end-user, which are liable to generate electromagnetic disturbances, or the performance of which is liable to be affected by such disturbance, shall be considered apparatus.
The RoHS Directive (2011/65/EU) and its amendments [10] - The Denali Safe NET servo drives fall under the RoHS Directive in their capacity as Electrical and Electronic Equipment.
Additionally, the Denali Safe NETis subject to general product regulations such as REACH and the Market Surveillance Regulation, among others. As these regulations do not require CE marking, and do not call for a Technical Documentation File to be drawn up, their compliance will be managed outside of this Technical Documentation File.
No formal conformity assessment is required for sale in the USA, CAN, MEX, IND, CHN, JPN, TWN and KOR at the time of writing.
Voluntary Requirements
The Denali Safe NET EtherCAT version holds the following voluntary certificates at this time, applicable to the USA and CAN markets:
Product | Certificate ID | Certificate Type | Certified to | Certified by | Date of Issue | Status and expiration | Product marking |
DEN-S-NET-E | CU 72406396 | CU-Certificate  | UL 61800-5-1:2022, | TÜV Rheinland of North America Inc. | VALID CERTIFICATE Valid thru:AS LONG AS EXTENDED | cTUVus Mark: 
|
Conclusion
Apart from the requirements listed above, and after careful scope review, the product has not been found in scope of any other directive or regulation requiring to be included in the Technical Documentation File in any of the defined target markets.