ISO 14644-1:2015
Classification of air cleanliness by particle concentration in cleanrooms and controlled environments. Scope covers all commissioned healthcare and pharmaceutical installations.
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§01 / Regulatory Dossier
Triple-certified medical filtration, documented to the standard.
EcoMedPollutec holds simultaneous ISO 14644-1, ISO 13485, and EN 1822-1:2019 certification for medical-grade air and water pollution control installations across 34 countries. Every commissioned site ships with a full audit dossier — measurable, traceable, and ready for your infection control committee review.
Response within 4 business hours · NDA available on first contact
- ISO 14644-1
- ISO 13485
- EN 1822-1:2019
§02 / Audit Methodology
A four-stage compliance audit, engineered for procurement reviewers.
Every EcoMedPollutec compliance engagement follows a documented, repeatable methodology — from intake scoping to certificate issuance. Average on-site turnaround is 11 days, 4.3× faster than the EMEA industry median.
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01
Scoping & Documentation Intake
Joint review of facility drawings, prior audit reports, and applicable ISO/EN clauses. NDA executed within 24 hours of first contact.
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02
On-site Sampling & Measurement
Licensed clinical engineers deploy calibrated particulate and microbial counters per ISO 14644-3 and EN 1822-5 protocols across representative zones.
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03
Documentation & Non-conformance Review
Cross-reference of maintenance logs, sensor telemetry (PollutecSense™), and corrective action records against ISO 13485 quality management criteria.
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04
Certification Issuance
Signed certificate pack delivered with full traceable evidence dossier, valid for the regulatory period stated on each document and renewable through scheduled re-audit.
§03 / Certifications & Authoritative Documents
Documented evidence, issued by accredited bodies.
Each certificate below is issued by an EU-notified body or recognised international institution and may be requested in original, signed PDF form. Validity periods reflect the most recent reissue; re-audit is scheduled 90 days before expiry.
ISO 13485:2016
Medical devices — Quality management systems. Covers design, production, installation, and servicing of medical-grade filtration assemblies and related monitoring hardware.
Request Original PDFEN 1822-1:2019
High-efficiency air filters (EPA, HEPA, and ULPA) — classification, performance testing, and marking. Validates filter efficiency ratings across all installed HEPA and ULPA banks.
Request Original PDFWHO EMRO Partnership & Global HealthTech Award
Partnership documentation covering airborne infection prevention collaboration with the WHO Eastern Mediterranean Regional Office since 2019, plus the 2024 "Best Medical-Grade Pollution Control Provider — Europe" award citation.
§03 / Standards
Standards Cross-Reference Matrix
Scope coverage verified by auditors. Map each governing standard and institutional baseline to the EcoMedPollutec deliverable that satisfies it — from cleanroom classification and quality management to filter efficiency testing.
| Standard / Baseline | Scope | EcoMedPollutec Deliverable | Verification |
|---|---|---|---|
| ISO 14644-1 Cleanrooms — Classification of air cleanliness | Particle count limits and verification methodology for classified cleanrooms (ISO Class 1–9). | Cleanroom design, particle counting, and ISO Class certification for pharmacy compounding suites and operating theatres. | In-house certified |
| ISO 13485 Medical devices — Quality management systems | QMS requirements for organizations providing medical devices and related services. | Documented design control, traceability, and post-market surveillance across every installed filtration assembly. | Annual audit |
| EN 1822-1:2019 High-efficiency air filters — Classification, testing | EPA, HEPA, and ULPA filter classification (E10–U17) and performance testing methodology. | HEPA-grade filter specification, in-situ leak testing, and replacement cycle documentation per EN 1822-1:2019. | Triple-certified |
| WHO IAQ Guidelines Indoor air quality for healthcare facilities | Airborne pathogen control guidance issued through the WHO Eastern Mediterranean Regional Office. | PollutecSense™ real-time monitoring dashboards and airborne infection prevention playbooks co-developed with WHO EMRO since 2019. | EMRO partner |
| ISPE Baseline® Pharmaceutical engineering cleanroom guidance | ISPE guidance for aseptic processing and pharmaceutical cleanroom environmental control. | Class-A cleanroom monitoring with zero breach events across all managed pharmaceutical accounts for 42 consecutive months. | ISPE member |
EcoMedPollutec SAS holds simultaneous ISO 14644-1, ISO 13485, and EN 1822-1:2019 triple certification for medical filtration installations — the only EU-headquartered firm with this combination. Download certificate copies.
§04 / Field Telemetry
Field Telemetry & Institutional Partnerships
Measured uptime and partnership metrics backing every certificate above. Figures are drawn from PollutecSense™ operational telemetry and our institutional engagement record.
- PollutecSense™ uptime 99.94% Measured platform uptime over the last 12 months across 312 monitored hospitals.
- Hospitals monitored in real time 312 Active PollutecSense™ deployments logging particulate, pressure, and microbial index readouts.
- Sensor readings in 2024 4.7B Airborne contamination data points processed by the platform during calendar year 2024.
- WHO EMRO partnership 2019→ Named partner of the WHO Eastern Mediterranean Regional Office for airborne infection prevention projects since 2019.
§05 / Next Step
Request a Compliance Audit
Submit your facility profile and standards scope. A licensed clinical engineer from our 42-strong team will return a documented audit plan — typically within four business hours.
EcoMedPollutec SAS · 14 Rue des Capitaines, 69003 Lyon, France · [email protected] · ISO 14644-1 · ISO 13485 · EN 1822-1:2019