汉高乐泰HYSOL医疗级别用胶M-31CL

最近有一个做医疗器械的客户在找“具有生物相容性要求”的胶粘剂，不知道这个是需要胶水达到FDA认证，还是需要通过ISO 10993的认证，因为在此款产品的TDS资料中就有此一段的说明：“ ISO-10993，   An ISO 10993 Test Protocol is an integral part of the Quality Program for LOCTITE® M-31CL™. LOCTITE® M-31CL™ has been qualified to Loctite’s ISO 10993 Protocol as a means to assist in the selection of products for use in the medical device industry.” 简单看上去这个产品好像就是双组分的环氧胶，特殊之处就不得而知了。  摘录TDS如下，有兴趣的朋友可以下载TDS查看之：

PRODUCT DESCRIPTION
LOCTITE® M-31CL™ provides the following product
characteristics:
Technology Epoxy
Chemical Type Epoxy
Appearance (Resin) Clear colorless to slightly yellow
liquidLMS
Appearance (Hardener) Clear colorless to slightly yellow
liquidLMS
Appearance (Mixed) Ultra clear
Components Two part - Resin & Hardener
Viscosity Low
Mix Ratio (by weight)
Resin : Hardener
100 : 46
Mix Ratio (by volume)
Resin : Hardener
2 : 1
Cure Room temperature cure after mixing
Application Bonding
LOCTITE® M-31CL™ cures at room temperature once mixed,
to form an ultra-clear adhesive bondline with excellent impact
resistance and minimal shrinkage. The fully cured epoxy is
resistant to a wide range of chemicals and solvents and has
excellent dimensional stability over a wide temperature range.
Typical applications include bonding, small potting, staking and
laminating applications where optical clarity and excellent
structural, mechanical and electrical insulating properties are
required. LOCTITE® M-31CL™ bonds most materials including
glass, optical fibers, ceramics, metals, and many rigid plastics.
Suitable for use in the assembly of disposable medical
devices.
ISO-10993
An ISO 10993 Test Protocol is an integral part of the Quality
Program for LOCTITE® M-31CL™. LOCTITE® M-31CL™ has
been qualified to Loctite's ISO 10993 Protocol as a means to
assist in the selection of products for use in the medical device
industry. Certificates of Compliance are available at
www.loctite.com or through the Henkel Loctite Quality
Department.
TYPICAL PROPERTIES OF UNCURED MATERIAL
Resin:
Specific Gravity@ 25 °C 1.1
Flash Point - See MSDS
Viscosity, Brookfield - RVT, 25 °C, mPa·s (cP):
Spindle 6, speed 20 rpm 9,000 to 12,000LMS
Hardener:
Specific Gravity@ 25 °C 1.0
Flash Point - See MSDS
Viscosity, Brookfield - RVT, 25 °C, mPa·s (cP):
Spindle 5, speed 20 rpm 1,500 to 9,000LMS
Mixed:
Specific Gravity@ 25 °C 1.07

TYPICAL CURING PERFORMANCE
Gel Time
Gel time, 100 °C, seconds 90 to 150LMS
Working Life
Working life, minutes 30
Tack Free Time
Tack Free Time is the time required to achieve a tack free
surface.
Tack Free Time, (low humidity), minutes 160
Cure Speed vs. Time
The graph below shows shear strength developed with time on
Aluminum (etched & abraded) lapshears @ 25 °C with an
average bondline gap of 0.1 to 0.2 mm and tested according to
ISO 4587.
% of Full Strength on Aluminum
Cure Time
100
75
50
25
0
1min 5min 10min 30min 1h 3h 6h 24h 72h
TYPICAL PROPERTIES OF CURED MATERIAL
Cured @ 25 °C except where noted
Physical Properties:
Glass Transition Temperature, ASTM E 228, °C 70
Elongation, ASTM D 638, % 8
Tensile Strength, ASTM D 638 N/mm² 55.2
(psi) (8,000)
Shore Hardness, ISO 868, Durometer D:
Cured @ 22 °C for 16 to 18 hours
followed by 2 hours @ 65 °C
80 to 90LMS
Electrical Properties:
Dielectric Breakdown Strength, IEC 60243-1, kV/mm 19.7
TYPICAL PERFORMANCE OF CURED MATERIAL
Adhesive Properties
Cured @ 65 °C for 2 hours
Lap Shear Strength, ISO 4587:
Aluminum (etched & abraded), 0.13 mm
gap
N/mm² ≥6.9LMS
(psi) (≥1,000)
Cured @ 22 °C for 5 days
Lap Shear Strength, ISO 4587:
Steel (grit blasted) N/mm² 21.4
(psi) (3,100)

TYPICAL CURING PERFORMANCE
Gel Time
Gel time, 100 °C, seconds 90 to 150LMS
Working Life
Working life, minutes 30
Tack Free Time
Tack Free Time is the time required to achieve a tack free
surface.
Tack Free Time, (low humidity), minutes 160
Cure Speed vs. Time
The graph below shows shear strength developed with time on
Aluminum (etched & abraded) lapshears @ 25 °C with an
average bondline gap of 0.1 to 0.2 mm and tested according to
ISO 4587.
% of Full Strength on Aluminum
Cure Time
100
75
50
25
0
1min 5min 10min 30min 1h 3h 6h 24h 72h
TYPICAL PROPERTIES OF CURED MATERIAL
Cured @ 25 °C except where noted
Physical Properties:
Glass Transition Temperature, ASTM E 228, °C 70
Elongation, ASTM D 638, % 8
Tensile Strength, ASTM D 638 N/mm² 55.2
(psi) (8,000)
Shore Hardness, ISO 868, Durometer D:
Cured @ 22 °C for 16 to 18 hours
followed by 2 hours @ 65 °C
80 to 90LMS
Electrical Properties:
Dielectric Breakdown Strength, IEC 60243-1, kV/mm 19.7
TYPICAL PERFORMANCE OF CURED MATERIAL
Adhesive Properties
Cured @ 65 °C for 2 hours
Lap Shear Strength, ISO 4587:
Aluminum (etched & abraded), 0.13 mm
gap
N/mm² ≥6.9LMS
(psi) (≥1,000)
Cured @ 22 °C for 5 days
Lap Shear Strength, ISO 4587:
Steel (grit blasted) N/mm² 21.4
(psi) (3,100)

Chemical/Solvent Resistance
Cured for 5 days @ 22 °C, on steel, aged under conditions
indicated and tested @ 22°C
% of initial strength
Environment °C 500 h 1000 h
Air 87 155 150
Motor oil (10W-30) 87 160 145
Unleaded gasoline 87 120 110
Water/glycol 50/50 87 145 140
Salt fog 22 70 85
95% RH 38 105 115
Condensing Humidity 49 90 90
Water 22 100 90
Acetone 22 100 105
IPA 22 120 120
Effects of Sterilization
In general, products similiar in composition to LOCTITE®
M-31CL™ subjected to standard sterilization methods, such as
EtO and Gamma Radiation (25 to 50 kiloGrays cumulative)
show excellent bond strength retention. LOCTITE® M-31CL™
maintains bond strength after 1 cycle of steam autoclave. It is
recommended that customers test specific parts after
subjecting them to the perferred sterilization method. Consult
with Loctite® for a product recommendation if your device will
see more than 3 sterilization cycles.
GENERAL INFORMATION
This product is not recommended for use in pure oxygen
and/or oxygen rich systems and should not be selected as
a sealant for chlorine or other strong oxidizing materials.
For safe handling information on this product, consult the
Material Safety Data Sheet (MSDS).
Directions for use
1. For high strength structural bonds, remove surface
contaminates such as paint, oxide films, oils, dust, mold
release agents and all other surface contaminates.
2. Use gloves to minimize skin contact. DO NOT use
solvents for cleaning hands.
3. Dual Cartridges: To use simply insert the cartridge into
the application gun and start the plunger into the cylinders
using light pressure on the trigger. Next, remove the
cartridge cap and expel a small amount of adhesive to be
sure both sides are flowing evenly and freely. If automatic
mixing of resin and hardener is desired, attach the mixing
nozzle to the end of the cartridge and begin dispensing
the adhesive. For hand mixing, expel the desired amount
of the adhesive and mix thoroughly. Mix for approximately
15 seconds after uniform color is obtained.
4. For maximum bond strength apply adhesive evenly to
both surfaces to be joined.
5. Application to the substrates should be made within 30
minutes. Larger quantities and/or higher temperatures
will reduce this working time.
6. Join the adhesive coated surfaces and allow to cure at 25
°C for 24 hours for high strength. Heat up to 93 °C, will
speed curing.
7. Keep parts from moving during cure. Contact pressure is
neccesary. Maximum shear strength is obtained with a 0.1
to 0.2 mm bond line.

8. Excessive uncured adhesive can be cleaned up with

ketone type solven

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