At Staiger, quality, safety, and regulatory compliance are integral parts of our product development and manufacturing processes. Our valves are designed and produced in accordance with international standards to ensure reliability, environmental responsibility, and market acceptance worldwide.
This page provides an overview of our key compliance frameworks and certifications.
Full Material Transparency Across the Supply Chain!
Many international regulations require detailed documentation of materials used in products. To support this requirement, Staiger performs Bill of Materials (BOM) verification and maintains Full Material Declarations (FMD) across the entire valve assembly.
This means every material used in our valves is documented and traceable. With this approach, we can verify material compliance against relevant regulations and substance restrictions whenever required.
Maintaining a complete material declaration enables us to respond quickly to new regulatory requirements and provide transparency to our customers.
Restriction of Hazardous Substances
The RoHS Directive restricts the use of specific hazardous materials in electrical and electronic equipment. Directive 2011/65/EU (RoHS2) and its amendment 2015/863 (RoHS3) extend these restrictions by adding additional substances listed in Annex II of the directive. Staiger ensures that materials used in our valves comply with these restrictions, supporting environmentally responsible product design and regulatory compliance for electronic components.
Registration, Evaluation, Authorization and Restriction of Chemicals
REACH (Regulation (EC) No. 1907/2006) is the European Union regulation governing the safe use of chemical substances to protect human health and the environment. It requires manufacturers and suppliers to evaluate chemical risks and ensure transparency regarding substances used in products. At Staiger, we monitor substances of very high concern (SVHC) and maintain full material transparency through Bill of Materials (BOM) verification and Full Material Declarations (FMD), enabling verification of material compliance with REACH requirements.
Conformité Européenne
The CE marking indicates conformity with applicable European directives and regulations, allowing products to be placed on the European market. Where applicable, Staiger products comply with relevant EU directives such as:
- Machinery Directive
- Low Voltage Directive
- EMC Directive
CE conformity confirms that our products meet essential health, safety, and environmental protection requirements.
Medical Device Regulation
The Medical Device Regulation (EU) 2017/745 defines strict requirements for materials and components used in medical devices within the European Union. It includes restrictions and transparency requirements for hazardous substances such as CMR 1A and 1B substances. These classifications are referenced under the CLP Regulation (EU) 1272/2008, specifically in Annex VI Part 3 of the EU chemicals regulation. Staiger supports medical technology applications by providing detailed material documentation and traceability to assist customers with MDR compliance.
Quality Management
Staiger operates under a certified quality management system in accordance with ISO 9001. Our processes focus on continuous improvement, traceability, and consistent product quality across all manufacturing stages.
Product-Specific Certifications
Depending on the application, additional certifications or declarations may be available, including:
- Material declarations
- Biocompatibility information (e.g., ISO 10993 references)
- Oxygen compatibility
- Customer-specific compliance documentation
In addition, we support customers with material compliance for further regulatory requirements such as CLP Regulation (EU) 1272/2008, POP Regulation (EU) 2019/1021, PFAS-related substance restrictions, and California Proposition 65. Through complete Bill of Materials (BOM) verification and Full Material Declarations across our valve assemblies, Staiger ensures transparency and traceability to help customers meet evolving regulatory and market requirements.
For detailed information regarding certifications or regulatory documentation for a specific product, please contact our technical or sales team.
Our Commitment
Compliance is not just a regulatory requirement — it is part of our responsibility toward customers, partners, and the environment. We continuously review legal requirements and adapt our processes to ensure long-term conformity and reliability.
If you require compliance documents, declarations, or certification details for a specific valve or project: Contact our team for compliance documentation and support!