Luminix Health Laboratory Guide: EU compliance, filtration and lab calculations

Luminix Health Laboratory Guide cover: EU compliance, filtration and lab calculations

The Luminix Health Laboratory Guide is a free 54-page PDF for laboratory and hospital professionals. It explains what EU law (MDR, IVDR, REACH, CLP) expects from the products you buy, how to choose and use syringe filters, and how to do everyday lab calculations, with sources linked to EUR-Lex, ECHA, NIST and ISO.

Luminix Health is a European supplier and distributor of laboratory and hospital supplies, with 150.000+ products and delivery across Europe in two to five days if in stock. This guide collects what we use every day when we help laboratories source their supplies.

Download the Laboratory Guide (PDF, 54 pages)

Free download, no form. English, 2.4 MB.

Last updated: 24 October 2026

What is in the guide

Three parts, 15 chapters and a reference section with glossary, FAQ and the official sources.

Part I: Buying lab supplies in Europe

The EU regulatory landscape (MDR, IVDR, REACH, CLP, WEEE/RoHS, GLP, ISO 15189 and ISO/IEC 17025), the documents that should come with your products (SDS, CoA, EU Declaration of Conformity, UDI/EUDAMED), smart procurement and supplier checklists.

Part II: Sample preparation and filtration

Membrane materials, chemical compatibility, pore size and diameter, filtration for HPLC/UHPLC, sterile filtration and the most common mistakes, with a decision flowchart.

Part III: Lab calculations

RCF and rpm, dilutions and molarity, pH, buffers and pKa, the Beer–Lambert law, units and constants, each with worked examples.

Who the guide is for

Laboratory managers, quality officers, hospital laboratory teams, researchers and procurement buyers working in European laboratories.

Which EU rules apply to laboratory supplies?

The legal framework depends on what a product is and on the intended purpose its manufacturer assigns to it. Several frameworks can apply to one product at the same time.

Product category EU act
Medical devices used in care Regulation (EU) 2017/745 (MDR)
IVD reagents, kits, analysers, specimen receptacles Regulation (EU) 2017/746 (IVDR)
Chemicals and mixtures (registration, SDS, SVHC) Regulation (EC) 1907/2006 (REACH)
Hazard classification, labels, pictograms Regulation (EC) 1272/2008 (CLP)
Electrical lab equipment: safety and EMC Directive 2014/35/EU, Directive 2014/30/EU (EN 61010-1)
End-of-life electrical equipment; restricted substances Directive 2012/19/EU (WEEE), Directive 2011/65/EU (RoHS)
Quality framework of the laboratory GLP, Directive 2004/10/EC, ISO 15189, ISO/IEC 17025

Key point: under the MDR and IVDR, a product is not an IVD because a hospital laboratory uses it; it is an IVD because its manufacturer intends it for in vitro diagnostic examination. Specimen receptacles are deemed IVDs (IVDR Article 2(2)).

Key EU regulatory dates 2026–2030

Status as of 24 October 2026. Dates move; always check the consolidated text on EUR-Lex.

Date Legal act What applies
28 May 2026 Decision (EU) 2025/2371 First four EUDAMED modules mandatory
1 July 2026 / 1 January 2027 Regulation (EU) 2024/2865 Staged application of the CLP revision
1 November 2026 Delegated Regulation (EU) 2023/707 End of transition for substances already on the market (new CLP hazard classes)
20 January 2027 Regulation (EU) 2023/1230 Machinery Regulation replaces Directive 2006/42/EC
31 December 2027 IVDR / MDR transitional provisions (2023/607, 2024/1860) Legacy IVDs: class D and IVDD-certified devices; legacy MDR class III and IIb implantable devices (conditions apply)
1 January 2028 Regulation (EU) 2025/2439 CLP label formatting, relabelling deadlines, advertising and distance sales
1 May 2028 Delegated Regulation (EU) 2023/707 End of transition for mixtures already on the market
31 December 2028 IVDR / MDR transitional provisions Legacy IVDs class C; other legacy MDR devices (conditions apply)
31 December 2029 IVDR transitional provisions Legacy IVDs class B and sterile class A (conditions apply)
31 December 2030 IVDR Article 5(5)(d) Justification requirement for in-house devices

How to choose a syringe filter membrane

Choose a membrane that is chemically compatible with your solvent and low-binding for your analyte. Use 0.45 µm for conventional HPLC and 0.2 µm for UHPLC or sterile filtration. Compatibility is indicative: always check the manufacturer's chart, and remember that the housing (often PP) must be compatible too.

Sample solvent First choice Alternatives / notes
Water, buffers, culture media PES Hydrophilic PVDF, CA, nylon (not for proteins)
Protein or peptide solutions PES, hydrophilic PVDF RC, CA; avoid nylon
Methanol/water, acetonitrile/water RC, nylon, hydrophilic PVDF Hydrophilic PTFE; PES with low organic content
THF, dichloromethane, chloroform PTFE Check housing compatibility; filter quickly
DMSO, DMF PTFE, nylon RC; avoid PES and PVDF
Strong acids PTFE PVDF for many non-oxidising acids; avoid nylon
Strong bases PTFE Avoid PVDF, RC

Read the full comparison in our article PTFE, nylon, PES or PVDF syringe filters: which membrane should you choose? or browse syringe filters and filtration.

Which documents should a lab supplier provide?

Document What it shows Legal basis
Safety Data Sheet (SDS) Hazards and safe handling in 16 fixed sections, free of charge, in an official language of the Member State REACH Article 31 and Annex II (format: Regulation (EU) 2020/878)
Certificate of Analysis (CoA) Test results for the delivered lot Manufacturer quality system
EU Declaration of Conformity The manufacturer declares conformity; basis for CE marking (not a quality label, not an origin mark) MDR/IVDR Annex IV; product directives
UDI / EUDAMED registration Unique identification of medical devices and IVDs MDR Article 27, IVDR Article 24

Suppliers must provide an updated SDS when new information on hazards or risk management becomes available (REACH Article 31(9)).

Essential lab calculations

  • RCF: RCF (× g) = 1.118 × 10⁻⁵ × r (cm) × rpm². State centrifugation as × g with time, temperature and rotor, not as rpm.
  • Dilution: C₁V₁ = C₂V₂. Example: 10 mL of 0.1 M from a 1 M stock needs 1 mL stock made up to 10 mL.
  • Buffers: pH = pKa + log([A⁻]/[HA]); useful buffering range is about pKa ± 1. Tris pKa drops about 0.03 per °C, so pH 8.0 at 25 °C is about pH 8.6 at 4 °C.
  • Beer–Lambert: A = ε · c · l, linear only within limits; at A = 2 only 1 % of the light reaches the detector.

Try the lab calculators, see the scientific references or read scientific calculators and references for laboratory professionals. Terms are explained in the glossary and the abbreviations list.

Guides by category

Practical buyer guides per product category, each with tables, FAQs and sources.

Download the guide

Free, no form, no e-mail address needed.

Download the Laboratory Guide (PDF, 54 pages)

Need products from several brands? Send your complete list to sales@luminixhealth.com and receive one consolidated quotation.

Frequently asked questions

Who is the Laboratory Guide for?

Laboratory managers, hospital laboratory teams, quality officers and procurement buyers who buy and use laboratory supplies in Europe.

Is the guide free, and do I need to fill in a form?

Yes, it is free, and no form or e-mail address is needed. Click the download button to open the PDF (54 pages, English).

Is the guide legal advice?

No. It is general information, status as of 24 October 2026. Always check the current consolidated text of EU legislation on EUR-Lex and follow the manufacturer's instructions and your validated procedures.

Should I use 0.2 µm or 0.45 µm filters for HPLC?

Use 0.45 µm for conventional HPLC columns with 3–5 µm particles and 0.2 µm for UHPLC and columns with sub-2 µm particles. When in doubt, 0.2 µm protects both, at the cost of lower flow.

Why did my aqueous sample not pass through the PTFE filter?

Standard PTFE is hydrophobic and is not wetted by water. Use a hydrophilic membrane, a hydrophilic PTFE, or pre-wet the PTFE membrane with methanol or isopropanol and flush with water before filtering.

Which documents can Luminix Health provide?

As a distributor, we pass on the manufacturer documentation for the products we supply: typically the SDS, the CoA for the delivered lot, the EU Declaration of Conformity and certificates where applicable. List the documents you need in your request.

Does Luminix Health manufacture the products it supplies?

No. Luminix Health is a European supplier and distributor. We source products from established manufacturers and combine them in one catalogue of 150.000+ products, so you can order many brands through one quote.

How fast does Luminix Health deliver?

Across Europe in two to five days if in stock. For items ordered from the manufacturer, dangerous goods or cold-chain products, the expected date is stated on the quote.

Sources

The guide is general information and not legal advice. Status as of 24 October 2026; always check the current consolidated text on EUR-Lex.