6001643802_MSDS_MIS_Detergent_pf-094_EN_Rev A
Getinge Clean MIS Detergent
According to Regulation (EC) No. 1907/2006
Safety Data Sheet
SECTION 1: Identification of the Substance/Mixture and on the Company/Undertaking
1.1. Product Identifier
Product code PF-094
Trade name Getinge Clean MIS Detergent
1.2 Product Uses Relevant identified uses of the substance or mixture and uses
advised against. An enzymatic detergent for use in washer disinfec-
tors, ultrasonic baths and the manual cleaning of medical devices.
Specially formulated to clean complex minimally invasive surgical
instruments. Suitable for use on water resistant surfaces such as
stainless steel, ceramics, glass, plastics and soft metals.
1.3 Supplier Details of the supplier of the Safety Data Sheet.
Supplier:
Getinge Disinfection AB, Ljungadalsgatan 11, Box 1505,
SE-351 15 Växjö, Sweden
Phone: +46 (0)10 335 98 00
Web: www.getinge.com
E-mail: info@getinge.com
Supplier New Zealand:
Getinge Australia (NZ Branch)
Unit 4, 10 Cryers Road
East Tamaki, Auckland
Botany 2163
New Zealand
Phone: +64 9 272 90393
1.4 Emergency telephone For emergency event of spillage, inhalation or ingestion of products,
please contact the emergency hotline:
number
EU: +44 (0) 1235 239 670
Australia: +61 2801 44558
Japan: +81 345 789 341
China: +86 10 5100 3039
Middle East: +44 (0) 1235 239 671
New Zealand : +64 9929 1483
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SECTION 2: Hazards Identification
2.1 Classification of the substance or mixture
2.1.1 Classification Not classified as hazardous.
according to GHS
and 26 CFR 1910
2.2 Label elements Labelling according to GHS and 26 CFR 1910
Hazard pictograms: None
Signal word: None
Danger: None
Hazard statements: None
Precautionary statements:
P261 - Avoid breathing mist, spray, vapours.
P262 - Do not get in eyes, on skin, or on clothing
P281: Use personal protective equipment as required
See section 16 for definition
2.3 Other Hazards Contains enzymes. May produce an allergic reaction.
SECTION 3: Composition/Information on Ingredients
3.1 Material CAS number Level GHS Classification,
Hazard Statement
Subtilisins 9014-01-1 <1% Skin Irrit.2, H315
(Protease)
Eye Dam.1, H318
Resp.Sens.1, H334
STOT SE3, H335
Lipase (Triacyl 9001-62-1 <1% Not classified
glycerol)
Amylase 9000-90-2 <1% Resp.Sens.1, H334
Cellulase 9012-54-8 <1% Resp.Sens.1, H334
Ingredients N/A To 100% -
determined
not to be
hazardous
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SECTION 4: First Aid Measures
4.1 Description of first aid
measures
Eye contact: Rinse with plenty of running water for at least 10 minutes. Seek
medical attention if symptoms occur.
Skin contact: Remove contaminated clothing, wash skin with water and seek
medical attention if symptoms occur.
Inhalation: Remove to fresh air. Seek medical attention if symptoms occur.
Ingestion: Do not induce vomiting. If conscious, give water to rinse mouth and
one or two glasses of water to drink. Contact a doctor or a Poisons
Information Centre.
4.2 Most important Unknown
symptoms and ef-
fects, both acute and
delayed
4.3 Indication of any Treat symptomatically
immediate medical
attention and special
treatment needed
SECTION 5: Fire Fighting Measures
Not applicable
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SECTION 6: Accidental Release Measures
6.1 Personal Wear personal protection equipment.
precautions,
protective
equipment and
emergency
procedures
6.2 Environmental pre- Not applicable
cautions
6.3 Methods and material Absorb spill with inert material. Spill area should be flushed with
water to sewer (avoid high pressure rinsing). Do not use cleaning
for containment and methods that generate aerosol. Spilled concentrate should be
cleaning up removed as soon as possible to avoid drying and formation of duct.
Rinse with excess water.
SECTION 7: Handling and Storage
Shelf life: 36 months from the manufacturing date.
7.1 Precautions for safe Working processes must be organized in a manner that prevents the
inhalation of aerosols and mists or skin and eye contact.
handling
7.2 Conditions for safe Store in a cool, dry place protected from frost heat and direct
sunlight away from acids and strong oxidizing agents. Store upright
storage, including any in original containers. Keep container closed when not in use.
incompatibilities Storage temperature 5–25 °C.
7.3 Product Uses Dosing range 0.5–8 ml/lt. Dosages below 1.5 ml/lit water should
only be considered with soft or treated water. Check materials
compatibility before use. Ensure complete rinsing after use. Do not
mix with other chemicals.
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SECTION 8: Exposure Control and Personal Protection
8.1 Control Workplace exposure limits
parameters Sodium tetraborate 1mg/m3 REL-TWA (NiOSH)
Subtilisin 0.06μg/m3 REL-STEL (NiOSH)
8.2 Exposure controls These measures are recommended on the basis of common appli-
cation methods and may not be appropriate to all potential applica-
tions of the product. The user is responsible for carrying out a full risk
assessment for their specific processes and systems of work.
Eye protection: Wear eye protection if splashing is likely.
Hand protection: Wear nitrile or neoprene gloves. Exact choice of
glove depends on specific risk assessments.
Body protection: As necessary to prevent contact.
Respiratory protection: Use in a well ventilated area. Avoid breathing
vapour or spray. Wear a respirator if necessary.
Other protection: N/A
Personal protective equipment:
Exact PPE requirements should be determined from a specific risk
assessment of the processes being carried out.
Environmental protection: N/A
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SECTION 9: Physical and Chemical Properties
9.1 Information on Appearance: Blue liquid
basic physical and Odour: Faint odour
chemical
Odour threshold: N/A
properties
Melting point: N/A
Flash point: N/A
Evaporation rate: N/A
Flammability: N/A
Upper/lower flammability N/A
or explosive limits:
Auto-ignition temperature: N/A
Explosive properties: N/A
Oxidising properties: None
Decomposition tempera- N/A
ture
Vapour pressure: No data
Vapour density: N/A
Relative density at 20 °C: 1.05–1.12
Solubility: Easily soluble in water
Partition coefficient: n-octanol/water Not applicable
Viscosity: Less than 10 cSt
9.2 Other information
SECTION 10: Stability and Reactivity
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10.1 Reactivity Not reactive
10.2 Chemical stability The mixture is stable at normal ambient temperature (5–25 °C).
10.3 Possibility of No known hazardous reactions.
hazardous
reactions
10.4 Conditions to avoid Storing at temp above +25 °C
10.5 Incompatible Incompatible with oxidising agents and acids.
materials
10.6 Hazardous Does not decompose when used as intended.
decomposition
products
SECTION 11: Toxicological Information
11.1 Information on toxico-
logical effects
Eye contact: No known significant effects or critical hazards.
Skin contact: No known significant effects or critical hazards. May cause irritation
in sensitized individuals.
Inhalation: Not hazard in normal use. Breathing spray mist may cause irritation.
Ingestion: Exposure can cause nausea, headache and vomiting.
Long term: Based on current knowledge, no long term effects are anticipated if
used as recommended
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SECTION 12: Ecological Information
12.1 Toxicity Not classified as dangerous for the environment.
12.2 Persistence and Ingredients contained in this preparation comply with the biodegrad-
ability criteria of Regulation (EC) No 648/2004 on detergents.
degradability
12.3 Bioaccumulative Unknown
potential
12.4 Mobility in soil Unknown
12.5 Results of PBT and This mixture does not contain any substances that are assessed as
PBT or vPvB.
vPvB assessment
12.6 Other adverse effects No other adverse effects are anticipated.
SECTION 13: Disposal Considerations
13.1 Waste Treatment Disposal of unwanted product should be done in accordance with
local, state or national legislation. Empty containers should be rinsed
Methods with large quantity of water, and can be reused or recycle. Could be
disposed of to landfill or incinerated where permitted. Avoid release
to the environment.
SECTION 14: Transport Information
14.1 UN Number: Not classified
Tariff/TARIC 3402 90 90
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14.2 UN Proper Shipping N/A
Name:
14.3 Transport Hazard N/A
Class(es):
14.4 Packing Group: N/A
SECTION 15: Regulatory Information
15.1 Safety, health and Contents enzymes.
environmental regula- The formulation contains boron compounds at the combined level
tions/legislation below the specific concentration limit of the relevant classification
criteria as per GHS classification.
specific for the sub-
stance or mixture Enzymes
15.2 Chemical Safety Product Safety Phrases:
Assessment P261 - Avoid breathing mist, spray, vapours.
P262 - Do not get in eyes, on skin, or on clothing
P281 - Use personal protective equipment as required
Definition of Hazard statement codes:
H315 Causes skin irritation
H318 Causes serious eye damage
H334 May cause allergy or asthma symptoms or
breathing difficulties if inhaled
H335 May cause respiratory irritation
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SECTION 16: Other Information
Hazard statements Product Safety Phrases:
relating to ingredients
P261 - Avoid breathing mist, spray, vapours.
(see section 3):
P262 - Do not get in eyes, on skin, or on clothing
P281 - Use personal protective equipment as required
Definition of Hazard statement codes:
H315 Causes skin irritatio
H318 Causes serious eye damage
H334 May cause allergy or asthma symptoms or breathing
difficulties if inhaled
H335 May cause respiratory irritation
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This product should be stored, handled and used in accordance with good industrial practice and in
conformity with legal regulations. The information in this data sheets= is based on the present state of
our knowledge and is intended to describe products from the point of view of safety requirements and
thus should not be constructed as guaranteeing specific properties. It is for users to satisfy themselves
of the suitability of this product for their own applications.
Always consult and follow manufacturer’s recommendations for the reprocessing of medical devices as
per EN ISO 17664.
Date of SDS preparation: 23 February 2015
Getinge Infection Control AB
P O Box 69, SE-305 05 Getinge, Sweden
Phone: +46 10 335 00 00
info@getinge.com
www.getinge.com
Getinge Group is a leading global provider of products and systems that contribute to quality enhance-
ment and cost efficiency within healthcare and life sciences. We operate under the three brands of
ArjoHuntleigh, Getinge and Maquet. ArjoHuntleigh focuses on patient mobility and wound management
solutions. Getinge provides solutions for infection control within healthcare and contamination prevention
within life sciences. Maquet specializes in solutions, therapies and products for surgical interventions,
interventional cardiology and intensive care.