Well With Waves
SERVICE · COMPLIANCE

Quality checks & compliance

Secure usage, extend service life, and gain clarity: condition, traceability, recommendations and actionable decisions.

Complete visual inspectionFluoroscopy shielding checkIndividual & fleet reportAudit-ready traceabilityEN 61331-3
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THIS SERVICE INCLUDES
Visual inspectionIncluded
Shielding check (fluoroscopy)On request
Individual item reportIncluded
Fleet summary reportIncluded
Traceability & historyIncluded
Turnaround time5–10 business days
CoverageNationwide (France)
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Response within 24 business hours

THE 3 DECISION STATUSES
Compliant

Equipment meets all inspection criteria. Can be returned to service immediately.

Monitor

Non-critical anomaly detected. Short-term use possible; follow-up inspection scheduled.

Remove

Critical shielding or structural defect. Immediate withdrawal from clinical use recommended.

INSPECTION OPERATIONS PERFORMED

Inspection operations performed

Complete protocol — 20 inspection points covering visual check, shielding integrity, performance and documentation.

VISUAL INSPECTION
6 points
Seams and stitching
Continuity check, absence of tears or delamination.
Straps and closures
Elasticity, integrity of velcro, buckles and eyelets.
Fold zones
Detection of cracks, crazing or localised thinning in areas of repeated flexion.
Outer cover
Absence of perforations, tears, visible contamination or fabric degradation.
Overlap zones
Check of panel overlap areas (chasubles, two-piece ensembles).
Markings & labels
Legibility of reference, lead equivalence value and manufacture date.
SHIELDING INTEGRITY CHECK
5 points
Fluoroscopy (X-ray imaging)
Fluoroscope pass to visualise discontinuities, thinning zones or breaches in the shielding material.
Internal void and crack detection
Identification of delamination, bubbles or internal separations not visible on the surface.
Priority wear zone inspection
Enhanced inspection of shoulders, waistband, lateral flaps and chronic fold zones.
Defect mapping
Location and sizing of detected defects for assessment and decision-making.
Peripheral continuity check
Control of edges and panel junction zones to detect coverage gaps.
PERFORMANCE VERIFICATION
4 points
Declared vs measured lead equivalence
Comparison of measured attenuation (kV 50/70/90/110/150) against the declared label value.
Material ageing
Assessment of performance degradation due to age, storage or usage conditions.
EN 61331-3 specification compliance
Vérification that measured performance remains within tolerances defined by the standard.
Inter-panel junction zone check
For chasubles and two-piece ensembles: vérification of effective coverage at assembly zones.
TRACEABILITY & DOCUMENTATION
5 points
Equipment identification
Vérification of unique reference, equivalence and commissioning date.
History update
Recording results, anomalies and actions in the item lifecycle file.
Individual inspection report
Per-item summary: overall status, anomalies, decision and follow-up recommendations.
Fleet summary report
Fleet overview: status distribution, renewal priorities.
Next inspection date recommendation
Adapted inspection frequency defined based on condition and usage intensity.
STANDARDS & REGULATORY FRAMEWORK

Standards & regulatory framework

Our inspections are based on current European standards and French regulatory recommendations.

EN 61331-3
Protective devices against diagnostic médical X-radiation

Primary European standard. Defines attenuation test methods at multiple voltages (50–150 kV), minimum performance levels and marking requirements for radiation protection PPE.

CENELECActive reference
IEC 61331-1
X-ray protective materials

Defines characteristics of protective materials (lead, lead-free, lead-light) and measurement methods for lead equivalence.

IEC / CENELECActive reference
IEC 61331-2
Protective spectacles against X-rays

Covers eye protection. Referenced for fleet checks including leaded glasses.

IEC / CENELECApplicable for glasses
Labour Code R.4451
Protection of workers against ionising radiation

French regulation. Requires appointment of a Radiation Protection Competent Person (RPC) and a regular equipment control programme.

French Labour MinistryLegal obligation
ASN — Guide RP 2.7.0
Control of individual radiation protection equipment

French Nuclear Safety Authority recommendations on frequency and methods for PPE inspection. Operational reference for healthcare facilities.

ASN (France)Regulatory recommendation
PROCESS

5-step protocol

A rigorous protocol, designed to be actionable and adapted to your context.

01
1) Alignment
Inventory, check level, frequency, operational constraints.
02
2) Collection / intake
Intake, ID vérification and sorting.
03
3) Inspection & checks
Visual inspection + shielding integrity checks.
04
4) Summary
Per-item decision + action prioritization.
05
5) Traceability
History updated + recommended next check date.
WHY THIS SERVICE MATTERS

Regulatory risk reduction

An unchecked fleet exposes the facility to R.4451 non-compliance risk. Regular checks provide documented proof of due diligence.

Fleet budget optimisation

Targeting replacements at dégradéd equipment — rather than vague age criteria — reduces unnecessary spending.

Audit-ready traceability

Individual and summary reports ready for internal audit, ASN inspection or quality certification (HAS, ISO).

End-to-end lifecycle management

Quality checks form a full A-to-Z fleet management continuum.

✓ BENEFITS
Reduces risk of using dégradéd equipment.
Clear, traceable decisions.
Optimizes replacement targeting.
Supports a stronger quality culture.
⚠ CONSIDERATIONS
Logistics organization (temporary immobilization).
Frequency must match usage intensity.
May reveal renewal needs (to anticipate).
QUALITY, HYGIÈNE & COMPLIANCE

A good check must be usable: readable, traceable and actionable—with evidence aligned to your context.

Simple results: compliant / monitor / non-compliant.
Cycle history and actions.
Rotation guidance to reduce localized wear.
Option to combine with disinfection.
FAQ
How often should we check?

It depends on usage intensity. We set a practical schedule during alignment.

What’s in the report?

Per-item summary + recommended actions (monitor, repair, remove, replace).

How long is equipment immobilized?

Depends on volume and protocol. Rotations can minimize impact.

What if an item is non-compliant?

We prioritize and recommend the safest action based on condition and usage.

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Flexible solutions for temporary needs, replacements or fast capacity ramp-up.

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LET’S DISCUSS YOUR NEEDS

Start a fleet inspection

Share your context (duration, quantities, constraints). We’ll propose the right approach.

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