--- type: "WebPage" title: "Analysis of cleaning residues on Medical Devices in the laboratory according to ISO 19227" description: "The FILAB laboratory supports manufacturers in the characterization of cleaning residues according to ISO 19227 and the interpretation of analytical results.This standard defines an integrated methodological approach linking cleaning process validation, biological evaluation, and sterilization validation of medical devices. Would..." resource: "https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/" tags: ["EN", "pll_612633efcd000", "Anaïs DECAUX"] timestamp: "2026-08-27T06:49:32Z" published: "2021-08-25T12:14:18Z" language: "en" author: "bwa" --- # Analysis of cleaning residues on Medical Devices in the laboratory according to ISO 19227 The FILAB laboratory supports manufacturers in the **characterization of cleaning residues according to ISO 19227**and **the interpretation of analytical results.** This standard defines an integrated methodological approach linking cleaning process validation, biological evaluation, and sterilization validation of medical devices. ## Would you like to carry out a cleaning residue analysis on your medical devices according to ISO 19227? ### ISO 19227:2018 Standard for medical devices: what is it about? The **international standard ISO 19227:2018**, published in March 2018 and entitled “*Surgical implants — Cleanliness of orthopaedic implants — General requirements*”, sets out the **requirements relating to the cleanliness of orthopaedic implants as well as the validation of the cleaning processes used**. ### Purpose of ISO 19227 The purpose of cleaning validation under ISO 19227:2018 is to **verify the effectiveness of the cleaning process in reducing physical contaminants** (and therefore particulate), **chemical and microbiological** contaminants below a level defined by the customer. ## Call on FILAB, an ISO 19227 analysis laboratory for cleaning residue expertise ### FILAB COFRAC 17025 accredited for ISO 19227 analysis ![](https://filab.fr/wp-content/uploads/2026/06/Essais_RVB_-02-212x300.png) The FILAB laboratory is accredited by COFRAC ISO 17025 ([www.cofrac.fr](https://www.cofrac.fr/)), according to validated and documented methods, helping you bring your activities into compliance with the requirements of [ISO 19227](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md) for your metal, ceramic and polymer medical devices. ## Organic contaminant analysis [Analysis of total hydrocarbon residue (THC) by GC-FID](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/analysis-of-total-hydrocarbon-residues-hct-by-gc-fid.md) [TOC analysis on medical devices](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/laboratory-analysis-measurements-total-organic-carbon-toc.md) [Measurement of Total Organic Carbonby TOC meter](https://filab.fr/en/our-technical-resources/analysis-by-total-organic-carbon-meter-in-laboratory.md) ## Inorganic contaminant analysis [Analysis of heavy metal residues by ICP](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-heavy-metal.md) [Analysis of mineral acid residues by CLI](https://filab.fr/nos-moyens-techniques/laboratoire-analysis-chromatographie-ionique/) [Analysis of cleaning agent residues by ICP](https://filab.fr/secteur-activite/analyse-industrie-pharmaceutique/laboratoire-analysis-ich-q3c/) [ISO 19227 cleaning agent residue analysis](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/laboratory-analysis-of-leachate-residues-according-to-iso-19227.md) ## Particulate contamination analysis Analysis by [Optical Microscopy](https://filab.fr/en/our-technical-resources/laboratory-of-analysis-and-observation-by-optical-microscope-mo.md) [Particulate contaminant analysis according to ISO 19227](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/analysis-of-particulate-contaminants-according-to-iso-19227.md) [Particle counting according to AAMI TIR42](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/particle-counting-laboratory-according-to-the-aami-tir42-standard.md), USP 788/789, [PE 2.9.19](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-injectable-drugs/particle-counting-laboratory-according-to-ep-2-9-19.md) (methods 1 and 2) [Particle counting on medical devices](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/particle-counting-laboratory-on-dm-according-to-iso-19227-standard.md) ## ISO 19227: Cleaning residue and associated contamination analysis In summary • **Organic contaminant analysis**: identification and quantification of organic residues: detergents, solvents, cleaning agents, process residues, or carbon-based compounds (HCT, TOC). **Organic contaminant analysis**: identification and quantification of organic residues: detergents, solvents, cleaning agents, process residues, or carbon-based compounds (HCT, TOC). • **Inorganic contaminant analysis**: detection and quantification of inorganic residues such as metals, mineral salts, or trace elements from cleaning or manufacturing processes. **Inorganic contaminant analysis**: detection and quantification of inorganic residues such as metals, mineral salts, or trace elements from cleaning or manufacturing processes. • **Particulate contamination analysis**: characterization of residual particles present after cleaning: size, nature, morphology, and distribution, in line with the cleanliness requirements for medical devices. **Particulate contamination analysis**: characterization of residual particles present after cleaning: size, nature, morphology, and distribution, in line with the cleanliness requirements for medical devices. • **Validation of analytical methods according to ISO 17025**: development, adaptation, and validation of cleaning residue analysis methods, including analytical performance, sensitivity, and repeatability, within the framework of ISO 19227 requirements. **Validation of analytical methods according to ISO 17025**: development, adaptation, and validation of cleaning residue analysis methods, including analytical performance, sensitivity, and repeatability, within the framework of ISO 19227 requirements. ## Our techniques [### TOC meter](https://filab.fr/en/our-technical-resources/analysis-by-total-organic-carbon-meter-in-laboratory.md) [### ICP](https://filab.fr/en/our-technical-resources/laboratory-analysis-icp-icp-ms-icp-aes.md) [### CLI](https://filab.fr/en/our-technical-resources/laboratory-ion-chromatography.md) ## Analytical method validation [Validation of extraction method completeness](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-exhaustiveness-verification-iso-10993-12.md) [Validation of medical device cleaning processes](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/validation-of-cleaning-processes-on-medical-devices.md) [Validation of analytical method and quantification](https://filab.fr/en/our-services/our-expertise-services/laboratory-analytical-method-validation/validation-of-analysis-and-dosage-methods-in-the-laboratory.md) ### Why carry out an ISO 19227 analysis? Identify and quantify the organic, inorganic, and particulate residues present after cleaning Provide actionable results for cleaning process validation Assess the biological risk prior to sterilization steps ## Why choose FILAB for your ISO 19227 analysis? In France, in the [medical device sector](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices.md), FILAB is one of the few laboratories with a complete analytical platform for carrying out cleaning residue analysis. These services draw on expertise in [chemical analysis](https://filab.fr/nos-prestations/analyse/analysis-chimiques/), both organic and inorganic, and in [materials characterization](https://filab.fr/en/our-services/our-analysis-services/laboratory-material-testing.md) of device components, such as metal alloys, ceramics, and polymers. At the FILAB laboratory, analysis are carried out using methods developed and validated according to ISO 17025, in line with ISO 19227, with protocols adapted to the materials, cleaning agents, and real-world conditions of industrial processes. Services ### The steps involved in carrying out analysis according to ISO 19227 Implementing ISO 19227:2018 therefore requires several steps to be carried out upstream by medical device manufacturers: A comprehensive review of the **risk analysis** related to cleaning. Risk management is an iterative process that must be carried out by the client throughout the design, validation, and use of the cleaning process. The design of a **cleaning process** based on the implant’s characteristics, its expected performance, and its manufacturing steps. The definition of minimum **cleanliness criteria** after final cleaning The **validation of cleaning methods** for each type of implant Biological **evaluation** according to ISO 10993-1 and validation of the sterilization process As part of this approach, the FILAB laboratory supports companies in the chemical analysis of cleaning residues (HCT/COT organic contaminants, inorganic and acidic residues, particulate contaminants) on medical devices. ## FAQ What is cleaning validation in the pharmaceutical industry? Cleaning validation in the pharmaceutical industry aims to demonstrate, through appropriate analysis, that cleaning processes effectively remove residues of active ingredients, excipients, detergents, or contaminants in order to ensure product safety and regulatory compliance. What does Medical Device cleaning validation involve? Cleaning validation for Medical Devices makes it possible to verify the removal of residues from manufacturing and cleaning processes, in order to control biological risk before sterilization, in accordance with normative and regulatory requirements. Why carry out a DM cleaning analysis in a laboratory? A DM cleaning analysis carried out in a laboratory makes it possible to identify, quantify, and characterize cleaning residues present on medical devices, in order to validate process effectiveness and support compliance documentation. What is the role of an ISO 19227 laboratory in cleaning validation? An ISO 19227 laboratory supports manufacturers in ISO 19227 analysis by establishing the link between cleaning validation, biological evaluation, and sterilization validation, notably through residue analysis tailored to medical devices. What types of residues can a laboratory analyze? A cleaning residue lab can analyze detergent residues, solvents, cleaning agents, organic or inorganic contaminants, as well as specific residues linked to industrial processes or device materials. What is the added value of a cleaning residue analysis laboratory? A cleaning residue analysis laboratory provides advanced analytical expertise for trace-level detection, reliable residue quantification, and interpretation of results in a pharmaceutical or medical device regulatory context. What does an HCT / COT assessment involve in the context of cleaning? An HCT COT assessment makes it possible to measure the residual organic load resulting from cleaning processes. This approach is commonly used for cleaning residue characterization and the overall assessment of surface cleanliness. How do you choose an ISO 19227 laboratory? The FILAB laboratory is COFRAC ISO 17025 accredited. This accreditation attests to the laboratory’s technical competence for carrying out cleaning residue analysis in compliance with the requirements of ISO 19227. How can you get a quote for a cleaning residue analysis? To obtain a quote for a cleaning residue analysis, our contact form is available. How long does it take to get a quote for a cleaning residue analysis? The quote for ISO 19227 analysis on Medical Devices is generally sent within 24 to 48 hours after receipt of the request via the form. Expertise, evidence and traceabilityUpdated: July 2026 ## Why trust the FILAB laboratory to analyze cleaning residues on Medical Devices according to ISO 19227? FILAB combines tailored analytical methods, expert interpretation of results, and a documented quality framework to produce data your teams can use. ### Recognized accreditations - ✓ ISO 17025 - ✓ FDA registered - ✓ CIR [Our accreditations](https://filab.fr/en/about-us/accreditations-en.md) ### Industry experience - Aerospace, energy, defense, metallurgy - Chemicals, healthcare, medical devices ### An expert at your side [in Benoît Persin](https:%5C/%5C/www.linkedin.com%5C/in%5C/benoitpersin%5C/) **Pharmaceutical industry expert** Benoît Persin supports analytical projects for the pharmaceutical industry and medical devices. [in Barbara Beauvais](https:%5C/%5C/www.linkedin.com%5C/in%5C/barbara-beauvais%5C/) **Chemical and pharmaceutical analysis expert** Barbara Beauvais supports chemical analysis, quality control and medical device projects. [in Clément Boenard](https:%5C/%5C/www.linkedin.com%5C/in%5C/cl%C3%A9ment-boenard-94b371b5%5C/) **Head of chemical expertise** Clément Boenard supports chemical analysis projects. [Our team](https://filab.fr/en/about-us/the-team.md) Verified reviews ## What our clients say L **Lucile g.** 10 June 2026 "I used Filab for a chemical analysis. Very satisfied with the service. Responsive team, deadlines met, and a clear analysis report. I recommend them." 5/5 N **Nicolas a.** 12 May 2026 "Very responsive laboratory, with excellent analysis quality and deadlines met. Communication is smooth, the technical explanations are clear, and the team knows how to adapt to specific needs. I recommend them for their professionalism and reliability!" 5/5 C **Charlotte t.** 8 May 2026 "Clear and precise deliverable, delivered on time. I recommend them." 5/5 Transparency & contact Last verified: July 2026 ## Where to find us and how to contact us FILAB is an independent, accredited physical laboratory located in France. All the contact details below allow you to verify our identity and start your request. ![FILAB laboratory facade](https://filab.fr/wp-content/uploads/2026/06/filab-exterieur.gif) ### FILAB Laboratory Ecoparc Dijon Bourgogne 80 rue Jean-Louis Auguste Petitjean 21850 Saint-Apollinaire, France Tél. [+33 (0)3 80 52 32 05](tel:+33380523205) [Request a quote](https://filab.fr/en/contact-form.md)