Medical Waste Product Test Data

ASSURED Medical Waste: Extreme Distribution Environment Certification

The following performance data is representative of polymer fusion label performance using several standards performed by ASSURED Testing of Ridgway, PA. on behalf of Medical Waste Management Brand for labeling to be used in extreme distribution environments.

REPORT OVERVIEW

Performance data is representative of polymer fusion label performance using several standards performed by ASSURED Testing of Ridgway, PA. on behalf of Medical Waste Management Brand

PERFORMANCE DATA

ASTM D7932-14 and MIL-STD 810G for labeling to be used in extreme distribution environments.

TEST NAMETEST SPEC / REQUIREMENTSURFACERESULT
Water Jet
Water JetWater Jet (122°F @ 1740psi)HDPE, PP Test PlaquesExceeded performance criteria
Part Washer
Part Washer250 Cycles @ 120°FHDPE, PP Test PlaquesExceeded performance criteria
High Temperature
High Temperature95–120°F for 24hrs for 7 DaysHDPE, PP Test PlaquesExceeded performance criteria
Low Temperature
Low Temperature-60°F for 72hrsHDPE, PP Test PlaquesExceeded performance criteria
Rainfall
Rainfall40MPH raindrops for 40minHDPE, PP Test PlaquesExceeded performance criteria
Salt Fog, Salt Spray
Salt Fog, Salt Spray5% salt solution at 95°FHDPE, PP Test PlaquesExceeded performance criteria
Blowing Dust
Blowing DustBlown dust @ 2mph for 6hrsHDPE, PP Test PlaquesExceeded performance criteria
Humidity
Humidity80°F, 95–100% humidity 45 daysHDPE, PP Test PlaquesExceeded performance criteria
Freeze / Thaw, Temperature Cycling
Temperature Cycling3 cycles 77°F, 95% RH to 18°FHDPE, PP Test PlaquesExceeded performance criteria
Accelerated Aging, Thermal Testing
Aging, Thermal150°F, 80% humidity, 96hrsHDPE, PP Test PlaquesExceeded performance criteria
Solar Radiation, Xenon Exposure
Solar, Xenon(56) 24 hour cyclesHDPE, PP Test PlaquesExceeded performance criteria
Abrasion Resistance, Desert
Abrasion, Desert500g @ 60rpm at 60°C ± 2HDPE, PP Test PlaquesExceeded performance criteria
Abrasion Resistance, Room Temperature
Abrasion, Room Temp.500g @ 60rpm at room temp.HDPE, PP Test PlaquesExceeded performance criteria
Abrasion Resistance, Cryogenic
Abrasion, Cryogenic500g @ 60rpm at -55°C ± 3HDPE, PP Test PlaquesExceeded performance criteria
Chemical Resistance Testing
Deionized Water8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
5% Salt Water8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
Windex8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
Betco AF67 Bathroom Cleaner8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
99% Isopropyl Alcohol8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
Dot 3 Brake Fluid8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
#2 Diesel Fuel8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
Nitric Acid - Ph 1.0±0.28hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
HCL - Ph 1.0 ± 0.28hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
Sodium Hydroxide - Ph 12±0.2 @ 5.25%8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
Sodium Hypochlorite - 5%8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
Quaternary Ammonium 200 ppm8hr. exposure, max 24hr dryHDPE, PP Test PlaquesExceeded performance criteria
FDA 510(k) Durability Requirement
600 Wash Cycles250ppm ZEP FSZ-Chlor (#2443)HDPE, PP Test PlaquesExceeded performance criteria
Water Jet
TEST NAME
Water Jet
TEST SPEC / REQUIREMENT
Water Jet (122°F @ 1740psi)
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Part Washer
TEST NAME
Part Washer
TEST SPEC / REQUIREMENT
250 Cycles @ 120°F
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
High Temperature
TEST NAME
High Temperature
TEST SPEC / REQUIREMENT
95–120°F for 24hrs for 7 Days
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Low Temperature
TEST NAME
Low Temperature
TEST SPEC / REQUIREMENT
-60°F for 72hrs
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Rainfall
TEST NAME
Rainfall
TEST SPEC / REQUIREMENT
40MPH raindrops for 40min
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Salt Fog, Salt Spray
TEST NAME
Salt Fog, Salt Spray
TEST SPEC / REQUIREMENT
5% salt solution at 95°F
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Blowing Dust
TEST NAME
Blowing Dust
TEST SPEC / REQUIREMENT
Blown dust @ 2mph for 6hrs
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Humidity
TEST NAME
Humidity
TEST SPEC / REQUIREMENT
80°F, 95–100% humidity 45 days
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Freeze / Thaw, Temperature Cycling
TEST NAME
Temperature Cycling
TEST SPEC / REQUIREMENT
3 cycles 77°F, 95% RH to 18°F
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Accelerated Aging, Thermal Testing
TEST NAME
Aging, Thermal
TEST SPEC / REQUIREMENT
150°F, 80% humidity, 96hrs
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Solar Radiation, Xenon Exposure
TEST NAME
Solar, Xenon
TEST SPEC / REQUIREMENT
(56) 24 hour cycles
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Abrasion Resistance, Desert
TEST NAME
Abrasion, Desert
TEST SPEC / REQUIREMENT
500g @ 60rpm at 60°C ± 2
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Abrasion Resistance, Room Temperature
TEST NAME
Abrasion, Room Temp.
TEST SPEC / REQUIREMENT
500g @ 60rpm at room temp.
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Abrasion Resistance, Cryogenic
TEST NAME
Abrasion, Cryogenic
TEST SPEC / REQUIREMENT
500g @ 60rpm at -55°C ± 3
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
Chemical Resistance Testing
TEST NAME
Deionized Water
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
5% Salt Water
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
Windex
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
Betco AF67 Bathroom Cleaner
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
99% Isopropyl Alcohol
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
Dot 3 Brake Fluid
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
#2 Diesel Fuel
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
Nitric Acid - Ph 1.0±0.2
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
HCL - Ph 1.0 ± 0.2
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
Sodium Hydroxide - Ph 12±0.2 @ 5.25%
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
Sodium Hypochlorite - 5%
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
TEST NAME
Quaternary Ammonium 200 ppm
TEST SPEC / REQUIREMENT
8hr. exposure, max 24hr dry
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria
FDA 510(k) Durability Requirement
TEST NAME
600 Wash Cycles
TEST SPEC / REQUIREMENT
250ppm ZEP FSZ-Chlor (#2443)
SURFACE
HDPE, PP Test Plaques
RESULT
Exceeded performance criteria

Test Criteria:

External Referenced Standards:

· Volvo STD 423-0015
· MIL-STD-810G
· ASTM D7932-14
· ASTM D3611
· ASTM D4332


Water Jet:
Volvo STD 423-0015. Water at 122 °F sprayed 4 inches from the substrate at approximately 1740psi and 4 gallons/minute. Using a manual power washer wand for 30 seconds sweeping across the sample at a rate of 1 wand sweep per second.

Part Washer:
One cycle will consist of an ECOLAB cleaning solution at 120 °F sprayed 15 inches at a 45 degree angle from the substrate at line pressure of 45psi and flow rate of 5 gallons/minute for 45 seconds. Immediately followed by a 10 second fresh water rinse at 160 °F. The substrate will then cool to room temperature before the next cycle. Test will conclude after 250 cycles or part failure.

High Temperature:
ASTM D7932-14, Section 11.6, as described in MIL-STD-810G, Method 501.6, Procedure I, Storage, Table 501.5-III for seven (7)-24 hour cycles (168 hours). Cycling of sample occurred at 95-120ºF for 24hrs for total of 7 Days.

Low Temperature:
ASTM D7932-14, Section 11.7, as described in MIL-STD-810G, Method 502.6, Procedure I, Storage, Design Type C3, -60º F for 72hrs.

Rainfall:
ASTM D7932-14, Section 11.8, as described in MIL-STD-810G, Method 506.6, Procedure II, Exaggerated Rain, Exposure duration will be 40mph for 40 minutes.

Salt Fog, Salt Spray:
ASTM D7932-14, Section 11.9, as described in MIL-STD-810G, Method 509.6, using a 5% ± 1% salt solution for four (4)-24 hour cycles, one cycle consists 24 hours salt spray, then 24 hours of drying time.

Blowing Dust:
ASTM D7932-14, Section 11.10, as described in MIL-STD-810G, Method 510.6, Procedure I. Dust particles were blown at 2mph for a total of 6hrs.

Humidity:
ASTM D7932-14, Section 11.11, as described in MIL-STD-80G, Method 507.6, Cycle B1, exposure duration will be 45 days (1080hours) at 80ºF cycling, 95-100% humidity.

Freeze / Thaw, Temperature Cycling:
ASTM D7932-14, Section 11.12, as described in MIL-STD-810G Method 524.1, Procedure III, Rapid Temperature Change, exposure duration will be 3 cycles at 77ºF, 95% humidity for 1hr to 18ºF for 1hr.

Accelerated Aging, Thermal Testing:
ASTM D7932-14, Section 11.13, as described in ASTM D3611, exposure to 150ºF at 80% humidity for 96 hours.

Solar Radiation, Xenon Exposure:
ASTM D7932-14, Section 11.15, as described in MIL-STD-810G, Method 5056, Procedure II, duration will be (56) 24 hour cycles, (1344hours) each cycle will consist of 20 hours of light and 4 hours of darkness.

Abrasion Resistance, Desert:
ASTM D7932-14, Section 11.5.1, followed by abrasion testing to be performed as described in Table 1 of ASTM D4332, for 24 hours, Sample conditioned at 60 °C ± 2 (140 °F ± 4) RH 15% ± 2 with a 500g weight on a wheel moving at 60rpm.

Abrasion Resistance, Room Temperature:
ASTM D7932-14, Section 11.5, to be performed as described in ASTM G195. Sample conditioned at room temp with a 500g weight on a wheel moving at 60rpm.

Abrasion Resistance, Cryogenic:
ASTM D7932-14, Section 11.5.1 followed by abrasion testing to be performed as described in Table 1 of ASTM D4332, for 24 hours. Sample conditioned at -55 °C ± 3 (-67 °F ± 6) with a 500g weight on a wheel moving at 60rpm.

Chemical Resistance Testing:
ASTM D7932-14, Sections 11.14-11.14.3, as described in MIL-STD 810G, Method 504.2, P procedure II, eight (8) hour exposure and max 24hr drying time.

FDA 510(k) Durability Requirement:
600 Wash Cycles. Wash Temperature - 140°F-160°F for approximately 50 seconds, Rinse Temperature 180°F-195°F for approximately 36 seconds, Dry Temperature 180°F-200°F for approximately 80 seconds.

Chemical in Wash Tank:
250ppm of free chlorine; using ZEP FS Z-Chlor (#2443)