Regulation

Examples of Medical Supplies

ISO (International Organization for Standardization)

Surgical instruments (e.g., scalpels, forceps), diagnostic imaging equipment (e.g., MRI machines, CT scanners), dental equipment (e.g., dental drills, chairs)

EU MDR (European Union Medical Device Regulation)

Implantable pacemakers, spinal implants, diagnostic ultrasound equipment, artificial joints

ASTM International

Surgical masks, N95 respirators, disposable face shields, protective eyewear

CE Marking (Conformité Européenne)

Endoscopes, ECG machines, defibrillators, blood glucose test strips

USP (United States Pharmacopeia)

Absorbable sutures: Polyglactin 910 (e.g., Vicryl), Polyglycolic acid (e.g., Dexon), Poliglecaprone 25 (e.g., Monocryl), Polydioxanone (e.g., PDS)<br>Non-absorbable sutures: Silk, Nylon, Polyester (e.g., Ethibond), Polypropylene (e.g., Prolene)

Medical Supply Name

Test Names

Equipment Used

ISO Standard Name and Number

Medical Gloves

Puncture Resistance Test

Puncture Test Device

ISO 11193-1

Permeability Test

Permeability Test Device

ISO 16604

Medical Masks

Bacterial Filtration Efficiency Test

BFE Test Device

ISO 22609

Fluid Resistance Test

Fluid Resistance Test Device

ISO 22609

Medical Syringes

Strength Test

Strength Test Device

ISO 7864

Leakage Test

Leakage Test Device

ISO 7886-1

Medical Gauze

Absorption Test

Absorption Test Device

ISO 9073-10

Strength Test

Strength Test Device

ISO 13938-1

Cannulas

Strength Test

Strength Test Device

ISO 10555-1

Flow Rate Test

Flow Rate Test Device

ISO 10555-1

Surgical Sutures

Tensile Strength Test

Tensile Tester

USP

Needle Attachment Strength Test

Needle Attachment Tester

USP

Blood Bags

Leak Test

Leak Test Device

ISO 3826-1

Strength Test

Strength Test Device

ISO 3826-1

Catheters

Kink Resistance Test

Kink Test Device

ISO 10555-1

Leakage Test

Leakage Test Device

ISO 10555-1

IV Tubing

Burst Pressure Test

Burst Pressure Tester

ISO 8536-4

Flow Rate Test

Flow Rate Test Device

ISO 8536-4

Thermometers

Accuracy Test

Calibration Device

ISO 80601-2-56

Response Time Test

Response Time Tester

ISO 80601-2-56

Surgical Instruments

Corrosion Resistance Test

Corrosion Test Device

ISO 7153-1

Hardness Test

Hardness Tester

ISO 7153-1

Wheelchairs

Static Stability Test

Stability Test Device

ISO 7176-1

Fatigue Test

Fatigue Test Machine

ISO 7176-8

Infusion Pumps

Accuracy Test

Calibration Device

ISO 60601-2-24

Flow Rate Test

Flow Rate Test Device

ISO 60601-2-24