Benchmarks for establishing whether or not a sufficient level of functional safety has been 
achieved include the probability of hazardous failures, the fault tolerance, and the quality that 
is to be ensured by avoiding systematic faults. This is expressed in the standards using specific 
classification. In IEC/EN 61508, IEC/EN 62061 "Safety Integrity Level" (SIL) and 
EN ISO 13849‑1 "Category" and "Performance Level" (PL).
A.4.2 Safety of machinery in Europe
The EU Directives that apply to the implementation of products are based on Article 95 of the 
EU contract, which regulates the free exchange of goods. These are based on a new global 
concept ("new approach", "global approach"): 
● EU Directives only specify general safety goals and define basic safety requirements.
● Technical details can be defined by means of standards by Standards Associations that 
have the appropriate mandate from the commission of the European Parliament and 
Council (CEN, CENELEC). These standards are harmonized in line with a specific directive 
and listed in the official journal of the commission of the European Parliament and Council. 
Legislation does not specify that certain standards have to be observed. When the 
harmonized Standards are observed, it can be assumed that the safety requirements and 
specifications of the Directives involved have been fulfilled.
● EU Directives specify that the Member States must mutually recognize domestic 
regulations.
The EU Directives are equal. This means that if several Directives apply for a specific piece 
of equipment or device, the requirements of all of the relevant Directives apply (e.g. for a 
machine with electrical equipment, the Machinery Directive and the Low-Voltage Directive 
apply).
A.4.2.1 Machinery Directive
The basic safety and health requirements specified in Annex I of the Directive must be fulfilled 
for the safety of machines. 
The protective goals must be implemented responsibly to ensure compliance with the Directive.
Manufacturers of a machine must verify that their machine complies with the basic 
requirements. This verification is facilitated by means of harmonized standards.
IEC 61800‑5‑2:2007 is relevant for the machinery directive: Adjustable-speed electrical power 
drive systems, Part 5-2: Safety requirements - Functional safety
Within the context of IEC 61508, IEC 61800‑5‑2 considers adjustable speed electric power 
drive systems (PDS), which are suitable for use in safety-related applications (PDS(SR)).
IEC 61800‑5‑2 places demands on PDS(SR) as subsystems of a safety-related system. This 
therefore permits the implementation of the electrical/electronic/programmable electronic 
elements of a PDS(SR) taking into account the safety-relevant performance of the safety 
function(s) of a PDS.
Manufacturers and suppliers of PDS(SR) can prove to users (e.g. integrators of control 
systems, developers of machines and plants etc.) the safety-relevant performance of their 
equipment by implementing the specifications stipulated in standard IEC 61800‑5‑2.
Appendix
A.4 Standards and specifications
Safety Integrated - SINAMICS G110M, G120, G120C, G120D and SIMATIC ET 200pro FC-2
422 Function Manual, 01/2017, FW V4.7 SP6, A5E34261271B AD