Surgical Devices
Every instrument, every barrier, tested.
Medical testing since 2020
One lab for surgical instruments and surgical PPE.
Tti Labs set up an accredited Medical Testing and Biocompatibility Laboratory in 2020, during the COVID-19 pandemic. It tests face masks, surgical gowns, medical textiles and other healthcare products critical to public safety. It also tests antimicrobial performance and runs microbiological analysis.
The U.S. IAC certified microbiology lab works in ISO Class 5 and Class 7 environments.
Division 15 at a glance
PNAC LAB 022 · U.S. IAC certified microbiology lab
8
Surgical instruments in the Division 15 scope
4
Test families, from sterility to strength
6
Surgical PPE types, from masks to coveralls
5 & 7
ISO Class environments for microbiology
BSL-2+
Stainless-steel facility for device testing
Every instrument, every barrier
Tti Labs tests medical devices and surgical products for safety, sterility, biocompatibility and functional performance.
Surgical instruments
Eight instruments, four test families.
Curettes
Ear cannula
Forceps
Needle holder
Probes / directors
Retractors
Scalpel
Scissors
Four test families
Sterility testing
Bacterial endotoxin (LAL) testing
Bioburden testing
Extractables & leachables, residual analysis, elemental impurities
Sterile packing test, container closure integrity
Mechanical strength, dimensional verification
The test families apply to the instrument range as a whole. Ask Tti Labs which tests suit your device.
Medical masks
Tti Labs tests sterile and non-sterile medical face masks to EN 14683:2019 and ASTM F2100:2019.
Bacterial filtration efficiency (BFE)
Particle filtration efficiency (PFE)
Synthetic blood penetration
Differential pressure (breathability)
Microbial cleanliness (bioburden)
Flammability
Gloves & coveralls
Surgical gloves protect healthcare professionals and patients from microbial contamination, chemical exposure and cross-infection.
EN 455 series: medical gloves for single use
EN ISO 374: protective gloves against dangerous chemicals and micro-organisms
EN ISO 21420: protective gloves, general requirements and test methods
ASTM D3577: rubber surgical gloves
ASTM D6319: nitrile examination gloves for medical application
ASTM D6978: resistance of medical gloves to permeation by chemotherapy drugs
Coveralls
Coveralls share the accredited matrix with masks, gowns and drapes. Methods cover synthetic blood penetration, bursting strength, dry microbial and wet bacterial penetration, bioburden and antibacterial finish.
Microbiology in clean air
Tti Labs runs medical device testing and surgical instrument evaluation in a stainless-steel BSL-2+ facility.
Its U.S. IAC certified microbiology lab works in ISO Class 5 and Class 7 environments.
Hygiene & infection control
Clinical disinfectants: performance testing
Hand sanitizers: performance testing
Environmental monitoring for the facility
Surgical devices: comprehensive evaluation
Gowns & drapes
Surgical gowns and drapes keep sterile barriers in place during medical procedures. They protect wearers from microbial and fluid exposure.
EU
EN 13795-1:2019
EN 13795-2:2019
EN 13034:2005+A1:2009
US
ASTM F2407:2019
ASTM F3352:2019
AAMI PB 70
Where devices sit in the rules
EU MDR and US FDA classes for instruments, surgical apparel and gloves.
EU, Regulation (EU) 2017/745, Annex VIII Rule 6: reusable surgical instruments are class I
US FDA, 21 CFR 878.4800: manual surgical instruments for general use are class I, 510(k) exempt, subject to 878.9
US FDA, 21 CFR 878.4040: surgical gowns & masks are class II
US FDA: non-powdered surgeon’s gloves (21 CFR 878.4460) and patient examination gloves (21 CFR 880.6250) are class I
Tti Labs tests samples and reports results under ISO/IEC 17025. Classification and conformity decisions rest with the manufacturer, the notified body and the regulator.
How each test is measured
Medical masks
EN 14683 · ASTM F2100
Test
What it shows
Method
Bacterial filtration efficiency (BFE)
How well the material stops a bacterial aerosol
ASTM F2101-25 / EN 14683:2025
Particle filtration efficiency (PFE)
How well the material stops sub-micron particles
ASTM F2299 / F2299M-24
Synthetic blood penetration
Whether a jet of synthetic blood passes the outer face
ASTM F1862 / F1862M-24 / ISO 22609:2004
Differential pressure (breathability)
Air resistance across the material
EN 14683:2025
Microbial cleanliness (bioburden)
Microorganisms carried on the finished mask
ISO 11737-1:2018/Amd 1:2021 / BS EN 14683:2025
Flammability
How the material behaves near a flame
Listed on ttilabs.net; no accredited method
Methods: PNAC LAB 022 Rev. 09 (3 Aug 2026), pp. 5–6, matrix “Textile Materials / PPE & Medical Devices”. The scope lists EN 14683:2025; ttilabs.net names the 2019 edition.
Gowns & drapes
Barrier & penetration
Test
Method
Synthetic blood penetration
ASTM F1670 / F1670M-25 · ISO 16603:2004
Dry microbial penetration
ISO 22612:2005
Wet bacterial penetration
ISO 22610:2018
Water penetration (hydrostatic pressure)
AATCC 127-2017(2018)e · ISO 811:2018 · EN 20811:1992
Water resistance, impact penetration
AATCC 42-2017e
Antibacterial finish
AATCC 100-2019 · AATCC 147-2011(2016)e · ASTM E2149-25
Strength & comfort
Test
Method
Tear strength (trapezoid)
ASTM D5587-15 (2024)
Seam strength
ASTM D751-19 · EN 14325:2018 + A1 (2024)
Bursting strength & distension (pneumatic)
ISO 13938-2:2019
Air permeability
ASTM D737-18 (2023) · ISO 9237:1995
Methods: PNAC LAB 022 Rev. 09, pp. 5–6. ttilabs.net also names viral penetration, lint generation and tensile strength; the PNAC scope has no method for them.
Microbiology
Tests
Test
Method
Sterility
USP <71>
Endotoxin
USP <85> & USP <161>
Bioburden
ISO 11737-1:2018/Amd 1:2021
Antibacterial finish
AATCC 100-2019 · AATCC 147-2011(2016)e · ASTM E2149-25
Clean-room classes
Class
Particles > 0.5 µm per m³
Active-air action level
ISO 5
3,520 · Class 100
1 cfu/m³
ISO 7
352,000 · Class 10,000
10 cfu/m³
Methods: PNAC LAB 022 Rev. 09. Sterility and endotoxin: p. 18, matrix “Pharma & Cosmeceutical Products”. Bioburden and antibacterial finish: pp. 5–6. Class limits: US FDA aseptic-processing guidance (Sep 2004), Table 1. They are reference limits, not Tti Labs measurements.
Gloves
US FDA · 21 CFR 800.20
Gloves
AQL
Surgeons’ gloves
1.5
Patient examination gloves
2.5
EN 455 · four parts
Part
Covers
01
Freedom from holes
02
Physical properties
03
Biological evaluation
04
Shelf life
FDA checks gloves by visual examination and a water leak test with 1,000 ml of water. It sets sample sizes at general inspection level II. FDA treats a lot as adulterated when defectives reach the rejection number. AQL: eCFR 21 CFR 800.20, current to 29 Sep 2026.
Accredited where it matters
ISO/IEC 17025 accredited testing laboratory, PNAC LAB 022
ISO/IEC 17020 accredited inspection body, PNAC IB-006 (Tti Inspections Pvt Ltd)
PNAC is a signatory to the Global ACI MRA (formerly ILAC MRA)
U.S. IAC certified microbiology lab
Approved for ISO Class 5 & 7 standards
2012
CPC Laboratory, Sialkot, acquired with PGMEA
2020
Medical & Biocompatibility Lab
2019–2021
IAC & medical devices: ISO Class 5 & 7, BSL-2+ facility
Need more details?
Division 15 · Surgical Devices
Surgical & medical devices testing