CERTIFICATIONS & COMPLIANCE
The compostability certifications, product conformity requirements and manufacturing standards supporting the relevant products across our range.
Our compostable range is supported by internationally recognised certification schemes and standards across relevant products. These provide an independent basis for the compostability claims associated with a particular material and finished product.
Home and industrial marks describe different treatment conditions. Certification is tied to its defined scope, including the product or material assessed.
CERTIFICATIONS AND REGULATORY REQUIREMENTS VARY BY PRODUCT. DOCUMENTATION AVAILABLE ON REQUEST.
Protection, clinical use and specimen handling have their own requirements. Relevant products across BioLine, CoreLine and LabLine are supplied with specifications and supporting compliance documentation for their intended application.
The document set can include an EU declaration of conformity, applicable CE information, product test reports, instructions and technical specifications. Requirements depend on the product classification and destination market.
The manufacturing systems supporting our range include relevant quality and environmental management standards, alongside packaging manufacturing and responsible sourcing programmes.
Management-system certificates apply to the organisation and activities within their scope. Social compliance programmes and supplier audits concern manufacturing practices; they are distinct from product certification.
Certification for controlled industrial composting. It does not establish home-composting suitability.
Certification for the lower-temperature conditions associated with home composting.
Packaging compostability standard addressing biodegradation, disintegration and compost quality.
A certification mark identifying industrial compostability within the certified scope.
North American compostability certification assessed against applicable ASTM standards.
A specification for plastics designed for aerobic composting in municipal or industrial facilities. A standard is distinct from a certification mark.
Australian standard for biodegradable plastics suitable for composting and other microbial treatment.
Australian standard for biodegradable plastics suitable for home composting.
Conformity marking for products subject to applicable EU legislation; supported by the relevant assessment and declaration.
The European regulatory framework for medical devices. Requirements depend on classification and intended use.
Performance requirements and test methods for medical face masks. The specified mask type determines the applicable performance requirements.
Performance requirements for surgical clothing and drapes. Supporting reports identify the product, tests and performance assessed.
Standards addressing protective gloves against dangerous chemicals and micro-organisms. Protection depends on the specific glove and test results.
An eye-protection standard referenced in relevant product documentation. The applicable standard and protection rating are confirmed for the supplied item.
General requirements for protective clothing, used alongside application-specific protection standards.
Applicable US regulatory status is documented by product. Registration, listing, clearance and approval are different; registration or listing alone does not establish FDA approval.
Quality management systems supporting controlled processes and continual improvement within the certified organisation and scope.
Environmental management systems addressing environmental responsibilities within the certified organisation and scope.
Quality management systems focused on medical-device processes and applicable regulatory requirements.
Site certification addressing quality, product safety and controlled manufacturing for packaging materials, within the certificate scope.
A responsible sourcing platform. Sedex membership and SMETA audits are not product certifications; relevant supplier information is assessed separately.
A supply-chain social performance programme. Supplier audit information concerns working conditions and social practices, rather than product certification.
MedSafe supports procurement with product-specific information that connects the item, its application and its supporting evidence.
Tell us the product reference and destination market, and our team will provide the relevant documentation for your enquiry.
TECHNICAL REFERENCES: TÜV AUSTRIA · BPI · CE MARKING · FDA
Request the certificates, specifications and compliance information relevant to your selected products.
