Z-003D-007-SJ-2.

Safety Data Sheet

Data of issue: 2010-09-10

Part I M-53D Diluent

1 Identification of the substance / mixture and of the company/undertaking
Information of the product
Product code A11-000136---（20L）
Product name M-53D DILUENT
Use of the Applied to Mindray BC-5300/BC-5100/BC-5380/BC-5180 Auto Hematology
substance/mixture Analyzer.
Manufacturer / supplier information
Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.，LTD

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.
China, 518057

Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500

Emergency Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500 (Mon-Fri: 08:30-18:00
telephone No. Beijng Time)

2 Hazards identification
Classification for This preparation is not dangerous under 1999/45/EC regulations and subsequent
supply amendments.
Health hazards See Section 11 for more information.
Environmental See Section 12 for more information.
hazards
Physico-chemical No information available.
hazards
Other hazards No information available.

3 Composition / information on ingredients

Components Components Concentration CAS No.
Sodium Sulphate Anhydrous 7.5-11.5g/L 7757-82-6
Sodium Chloride 3.5-5.5g/L 7647-14-5
Buffering Agents 1.0-3.0g/L
Anti-fungal and Anti-bacterial Agents 0.8-2.5g/L

4 First-aid measures
Skin contact Rinse immediately with plenty of water.
Eye contact Rinse immediately with plenty of water and seek medical advice.

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Ingestion Drink lots of water, induce vomiting. Seek medical advice immediately.
Inhalation Not applicable.

5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media CO2, extinguishing powder or water spray.
Special exposure None.
hazards
Protective equipment Fire fighters should wear an approved self-contained breathing apparatus and
for fire-fighters full protective clothing.

6 Accidental release measures

Personal Wear gloves and laboratory coat. Prevent skin and eye contacting.
precautions
environmental Keeping away from drains, surface- and ground-water and soil.
precautions
Methods for Use of absorbent material which should be disposed of in a dustbin. Clean
cleaning up with plenty of water.

7 Handling and storage

Handling No special precautions are necessary if used correctly.
Storage Store at 2-30℃, keep container closed.

8 Exposure controls / personal protection

Exposure limits None established.
Exposure Controls Not necessary.
Personal exposure Standard laboratory latex or rubber gloves recommended.
equipment
Environmental Not necessary.
exposure controls

9 Physico-chemical properties
Appearance Colourless liquid.
Odour Odourless.
pH ( 25±1°C ) 6.90±0.20
Melting point 0 °C.
Boiling point 100 °C.

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 Z-003D-007-SJ-2.0

Flash point Not applicable.

Explosive properties Not explosive.
Oxidizing properties Not applicable.
Autoignition Not applicable.
temperature
Vapour pressure No information available.
Relative density 1.000 - 1.023
Specific gravity (20 1.000 - 1.023 g/mL.
°C )
Solubility in water Soluble.
Solubility in solvents No information available.
Partition coefficient Not applicable.
Viscosity No information available.
Vapour density Not applicable.
Evaporation rate Not applicable.
Corrosivity to metal Not corrosive.

10 Stability and reactivity

Stability This product is stable.
Conditions to avoid Frozen, high temperature（above 30℃）.
Materials to avoid No information available.
Hazardous No information available.
decomposition
products

11 Toxicological information
Toxicokinetics, No experimental data for this preparation available.
metabolism and
distribution
Acute toxicity No experimental data for this preparation available.
Corrosivity/irritatio No corrosive/irritant effect.
n
Sensitisation No experimental data for this preparation available.
Repeated-dose No experimental data for this preparation available.
toxicity
Carcinogenicity/Mut No experimental data for this preparation available.
agenicity/Reproduci
tive toxicity

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 Z-003D-007-SJ-2.0

12 Ecological information
Ecotoxicity No information available.
Mobility No information available.
Persistence/degrada No information available.
bility
Bioaccumulation No information available.
potential
Results of PBT No information available.
assessment
Other adverse No information available.
effects

13 Disposal considerations
Product Dispose of waste product, unused product in accordance with governmental
requirements.

Packing Dispose of contaminated packaging in accordance with governmental

requirements.

14 Transport information
Transport / This substance is not dangerous under current provisions of the Code of
further International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID),
information of the International Maritime Dangerous Goods Code (IMDG), and of the
International Air Transport Association (IATA) regulations.

15 Regulations
Classification Preparation not classified.
and labelling DIRECTIVE 1999/45/EC
according to EC
REGULATION (EC) No 1907/2006 REACH
Directives
DIRECTIVE 2001/59/EC
DIRECTIVE 67/548/EEC

16 Other information
Revisions:2.0
Information of this Safety Data Sheet represents the today’s state of our knowledge. The purpose is to
characterise the product regarding safety precautions having to be kept. This document will not be a
certification of features and will not be the basis of a legal contract.

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 Z-003D-007-SJ-2.0

Part II M-53 CLEANSER

1 Identification of the substance / preparation and of the company
Information of the product
Product code A11-000127---（1L）, A11-000134---（1L×4）
Trade name M-53 CLEANSER
Use of the Applies to Mindray BC-5300/BC-5100/BC-5380/BC-5180 Auto Hematology
substance/mixture Analyzer. It is a cleaning solution formulated to prime and clean the fluidic
channels and tubing, and get rid of blood albumin and sediment.
Manufacturer / supplier information
Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.，LTD

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.
China, 518057

Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500

Emergency Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500 (Mon-Fri: 08:30-18:00
telephone No. Beijng Time)

2 Hazards identification
Classification for The preparation is not dangerous under 1999/45/EC regulations and subsequent
supply amendments.
Health hazards See Section 11 for more information.
Environmental See Section 12 for more information.
hazards
Physico-chemical No information available.
hazards
Other hazards No information available.

3 Composition / information on ingredients

M-53 CLEANSER Components Concentration CAS No.
Surfactant 0.5-2.0g/L
Buffering Agents 0.5-3.0g/L
Detergent enzyme 0.05-0.5g/L
Anti-fungal and Anti-bacterial Agents 0.01-1.0g/L

4 First-aid measures
Skin contact Rinse immediately with plenty of water.
Eye contact Rinse immediately with plenty of water and seek medical advice.
Ingestion Drink lemon juice, vinegar, or eggs in milk. Consult a physician immediately.
Inhalation Not applicable.
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5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media CO2, extinguishing powder or water spray.
Special exposure None.
hazards
Protective equipment Fire fighters should wear an approved self-contained breathing apparatus and
for fire-fighters full protective clothing.

6 Accidental release measures

Personal Wear gloves and laboratory coat. Prevent skin and eye contacting.
precautions
environmental Keeping away from drains, surface- and ground-water and soil.
precautions
Methods for Use of absorbent material which should be disposed of in a dustbin. Clean
cleaning up with plenty of water.

7 Handling and storage

Handling No special precautions are necessary if used correctly.
Storage Store at 2-30℃, keep container closed.

8 Exposure controls / personal protection

Exposure limits None established.
Exposure Controls Not necessary.
Personal exposure Standard laboratory latex or rubber gloves recommended.
equipment
Environmental Not necessary.
exposure controls

9 Physico-chemical properties
Appearance Colourless or yellowish.
Odour Slightly smell of surfactant.
±1°C)
pH (25± 8.4±0.5
Melting point 0 °C.
Boiling point 100 °C.
Flash point Not applicable.
Explosive properties Not explosive.
Oxidizing properties Not applicable.
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Autoignition Not applicable.

temperature
Vapour pressure No information available.
Relative density 1.00 - 1. 25
Specific gravity (20 1.00 - 1. 25 g/mL.
°C )
Solubility in water Soluble.
Solubility in solvents No information available.
Partition coefficient Not applicable.
Viscosity No information available.
Vapour density Not applicable.
Evaporation rate Not applicable.
Corrosivity to metal Not corrosive.

10 Stability and reactivity

Stability This product is stable.
Conditions to avoid Frozen, high temperature（above 30℃）.
Materials to avoid No information available.
Hazardous No information available.
decomposition
products

11 Toxicological information
Toxicokinetics, No experimental data for this preparation available.
metabolism and
distribution
Acute toxicity No experimental data for this preparation available.
Corrosivity/irritatio No corrosive/irritant effect.
n
Sensitisation No experimental data for this preparation available.
Repeated-dose No experimental data for this preparation available.
toxicity
Carcinogenicity/Mut No experimental data for this preparation available.
agenicity/Reproduci
tive toxicity

12 Ecological information
Ecotoxicity No information available.
Mobility No information available.

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 Z-003D-007-SJ-2.0

Persistence/degrada No information available.

bility
Bioaccumulation No information available.
potential
Results of PBT No information available.
assessment
Other adverse No information available.
effects

13 Disposal considerations
Product Dispose of waste product, unused product in accordance with governmental
requirements.

Packing Dispose of contaminated packaging in accordance with governmental

requirements.

14 Transport information
Transport / This substance is not dangerous under current provisions of the Code of
further International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID),
information of the International Maritime Dangerous Goods Code (IMDG), and of the
International Air Transport Association (IATA) regulations.

15 Regulations
Classification Preparation not classified.
and labelling DIRECTIVE 1999/45/EC
according to EC
REGULATION (EC) No 1907/2006 REACH
Directives
DIRECTIVE 2001/59/EC
DIRECTIVE 67/548/EEC

16 Other information
Revisions:2.0
Information of this Safety Data Sheet represents the today’s state of our knowledge. The purpose is to
characterise the product regarding safety precautions having to be kept. This document will not be a
certification of features and will not be the basis of a legal contract.

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 Z-003D-007-SJ-2.0

Ⅰ),M-53LEO(Ⅱ
Part III LYSE (M-53LEO(Ⅰ Ⅱ),M-53LH,M-53LBA)
1 Identification of the substance / preparation and of the company
Information of the product
M-53LEO(Ⅰ) LYSE A11-000120---（500mL）, A11-000119---（1L）, A11-000128---（1L×4）,
A11-000129---(4L)

M-53LEO(Ⅱ) LYSE A11-000121---（100mL）, A11-000122---（200mL）, A11-000123---

Product code
（400mL）, A11-000130---（200mL×4）, A11-000131---（400mL×4）

M-53LH LYSE A11-000124---（200mL）, A11-000125---（500mL）, A11-000126---（1L）,

A11-000132---（500mL×4）, A11-000133---（1L×4）

Product name Ⅰ) LYSE, M-53LEO(Ⅱ

M-53LEO(Ⅰ Ⅱ) LYSE, M-53LH LYSE
Use of the Applies to Mindray BC-5300/BC-5100/BC-5380/BC-5180 Auto Hematology
substance/mixture Analyzer.
Manufacturer / supplier information
Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.，LTD

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.
China, 518057

Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500

Emergency Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500 (Mon-Fri: 08:30-18:00
telephone No. Beijng Time)

2 Hazards identification
Classification for This preparation is not dangerous under 1999/45/EC regulations and subsequent
supply amendments.
Health hazards See Section 11 for more information.
Environmental See Section 12 for more information.
hazards
Physico-chemical No information available.
hazards
Other hazards No information available.

3 Composition / information on ingredients

Ⅰ)
M-53 LEO(Ⅰ Components Concentration CAS No.
LYSE Surfactant <35g/L
Ⅱ)
M-53 LEO(Ⅱ Components Concentration CAS No.
LYSE Surfactant <40g/L
Dye 0.01-0.1 g/L
Components Concentration CAS No.
M-53 LH LYSE
Quarternary Ammonium Salts <50g/L

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Isopropanol 2-10g/L

4 First-aid measures
Skin contact Rinse immediately with plenty of water.
Eye contact Rinse immediately with plenty of water and seek medical advice.
Ingestion Drink lots of water, induce vomiting. Seek medical advice immediately.
Inhalation Remove to fresh air.
Skin contact Rinse immediately with plenty of water.

5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media CO2, extinguishing powder or water spray.
Special exposure None.
hazards
Protective equipment Fire fighters should wear an approved self-contained breathing apparatus and
for fire-fighters full protective clothing.

6 Accidental release measures

Personal Wear gloves and laboratory coat. Prevent skin and eye contacting.
precautions
environmental Keeping away from drains, surface- and ground-water and soil.
precautions
Methods for Use of absorbent material which should be disposed of in a dustbin. Clean
cleaning up with plenty of water.

7 Handling and storage

Handling No special precautions are necessary if used correctly.
Storage Store at 2-30℃, keep container closed.

8 Exposure controls / personal protection

Exposure limits None established.
Exposure Controls Not necessary.
Personal exposure Standard laboratory latex or rubber gloves recommended.
equipment
Environmental Not necessary.
exposure controls

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9 Physico-chemical properties
Appearance M-53LEO(Ⅰ) LYSE,M-53LH LYSE colourless
M-53LEO(Ⅱ) LYSE pink
Odour Slightly smell of surfactant
pH ( 25±1°C ) M-53LEO(Ⅰ) LYSE 4.20±0.50
M-53LEO(Ⅱ) LYSE 10.80±0.50
M-53LH LYSE 2.20±0.50
Melting point 0 °C.
Boiling point 100 °C.
Flash point Not applicable.
Explosive properties Not explosive.
Oxidizing properties Not applicable.
Autoignition Not applicable.
temperature
Vapour pressure No information available.
Relative density 1.00-1.25
Specific gravity (20 1.00 - 1.25 g/mL.
°C )
Solubility in water Soluble.
Solubility in solvents Soluble.
Partition coefficient Not applicable.
Viscosity No information available.
Vapour density Not applicable.
Evaporation rate Not applicable.
Corrosivity to metal Not corrosive.

10 Stability and reactivity

Stability This product is stable.
Conditions to avoid Frozen, high temperature（above 30℃）.
Materials to avoid No information available.
Hazardous No information available.
decomposition
products

11 Toxicological information
Toxicokinetics, No experimental data for this preparation available.
metabolism and
distribution

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 Z-003D-007-SJ-2.0

Acute toxicity No experimental data for this preparation available.

Corrosivity/irritatio No corrosive/irritant effect.
n
Sensitisation No experimental data for this preparation available.
Repeated-dose No experimental data for this preparation available.
toxicity
Carcinogenicity/Mut No experimental data for this preparation available.
agenicity/Reproduci
tive toxicity

12 Ecological information
Ecotoxicity No information available.
Mobility No information available.
Persistence/degrada No information available.
bility
Bioaccumulation No information available.
potential
Results of PBT No information available.
assessment
Other adverse No information available.
effects

13 Disposal considerations
Product Dispose of waste product, unused product in accordance with governmental
requirements.

Packing Dispose of contaminated packaging in accordance with governmental

requirements.

14 Transport information
Transport / This substance is not dangerous under current provisions of the Code of
further International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID),
information of the International Maritime Dangerous Goods Code (IMDG), and of the
International Air Transport Association (IATA) regulations.

15 Regulations
Classification Preparation not classified.
and labelling DIRECTIVE 1999/45/EC
according to EC
REGULATION (EC) No 1907/2006 REACH
Directives
DIRECTIVE 2001/59/EC

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 Z-003D-007-SJ-2.0

DIRECTIVE 67/548/EEC

16 Other information
Revisions:2.0
Information of this Safety Data Sheet represents the today’s state of our knowledge. The purpose is to
characterise the product regarding safety precautions having to be kept. This document will not be a
certification of features and will not be the basis of a legal contract.

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 Z-003D-007-SJ-2.0

Part IV M-53P PROBE CLEANSER

1 Identification of the substance / preparation and of the company
Information of the product
Product code 003D-30-84194（50mL）
Product name M-53P PROBE CLEANSER
Use of the Applies to Mindray BC-5300/BC-5100/BC-5380/BC-5180 Auto Hematology
substance/mixture Analyzer. It is used to clean the analyzer regularly.
Manufacturer / supplier information
Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.，LTD

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.
China, 518057

Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500

Emergency Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500 (Mon-Fri: 08:30-18:00
telephone No. Beijng Time)

2 Hazards identification
Classification for This preparation is irritant under 67/548/EEC and 1999/45/EC regulations and
supply subsequent amendments.
Classification:Xi Phrases R:31-36/38
Health hazards The product is irritant to skin and eye.
Environmental See Section 12 for more information.
hazards
Physico-chemical No information available.
hazards
Other hazards Contact with acids liberates toxic gas.

3 Composition / information on ingredients

M-53P PROBE Components Concentration CAS No.
CLEANSER Surfactant <2.0g/L
Sodium hypochlorous <100 g/L
Sodium hydroxide <50 g/L

4 First-aid measures
Skin contact Rinse immediately with plenty of water.
Eye contact Rinse immediately with plenty of water and seek medical advice.
Ingestion Drink lemon juice, vinegar, or eggs in milk, avoid vomiting. Contact a physician
immediately.
Inhalation Remove to fresh air. If symptoms persist contact a physician.
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5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media CO2, extinguishing powder or water spray.
Special exposure None.
hazards
Protective equipment Fire fighters should wear an approved self-contained breathing apparatus and
for fire-fighters full protective clothing.

6 Accidental release measures

Personal Wear gloves and laboratory coat. Prevent skin and eye contacting.
precautions
environmental Keeping away from drains, surface- and ground-water and soil.
precautions
Methods for Use of absorbent material which should be disposed of in a dustbin. Clean
cleaning up with plenty of water.

7 Handling and storage

Handling Prevent skin and eye contacting.
Storage Store at 2-30℃, keep container closed in a dark and cool place.

8 Exposure controls / personal protection

Exposure limits None established.
Exposure Controls Necessary, if vapours / aerosols are released.
Personal exposure Standard laboratory latex or rubber gloves recommended.
equipment
Environmental Not necessary.
exposure controls

9 Physico-chemical properties
Appearance Yellowish-green liquid.
Odour Slightly pungent.
pH( 25±1 °C ) 10.0-13.8
Melting point 0 °C.
Boiling point 100 °C.
Flash point Not applicable.
Explosive properties Not explosive.
Oxidizing properties Oxide.
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Autoignition Not applicable.

temperature
Vapour pressure No information available.
Relative density 1.00 - 1. 25
Specific gravity (20 1.00 - 1. 25 g/mL.
°C )
Solubility in water Soluble.
Solubility in solvents Not soluble.
Partition coefficient Not applicable.
Viscosity No information available.
Vapour density Not applicable.
Evaporation rate Not applicable.
Corrosivity to metal Not corrosive.

10 Stability and reactivity

Stability This product is decomposable on high temperature.
Conditions to avoid High temperature（above 30℃）.
Materials to avoid Acids, ammonia, reducing agents.
Hazardous Chlorine.
decomposition
products

11 Toxicological information
Toxicokinetics, No experimental data for this preparation available.
metabolism and
distribution
Acute toxicity No experimental data for this preparation available.
Corrosivity/irritatio It is irritation of mucous membranes, after inhalation ,can cause cough,
n difficulty in breathing, irritatent for skin and eye contact.
Sensitisation No experimental data for this preparation available.
Repeated-dose No experimental data for this preparation available.
toxicity
Carcinogenicity/Mut No experimental data for this preparation available.
agenicity/Reproduci
tive toxicity

12 Ecological information
Ecotoxicity No information available.
Mobility No information available.

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Persistence/degrada No information available.

bility
Bioaccumulation No information available.
potential
Results of PBT No information available.
assessment
Other adverse Do not discard to inshore waters, sink or ground.
effects

13 Disposal considerations
Product Dispose of waste product, unused product in accordance with governmental
requirements.

Packing Dispose of contaminated packaging in accordance with governmental

requirements.

14 Transport information
Transport / This substance is not dangerous under current provisions of the Code of
further International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID),
information of the International Maritime Dangerous Goods Code (IMDG), and of the
International Air Transport Association (IATA) regulations.

15 Regulations
Classification and Preparation is classified Xi.
labelling according
to EC Directives

DIRECTIVE 1999/45/EC
REGULATION (EC) No 1907/2006 REACH
DIRECTIVE 2001/59/EC
DIRECTIVE 67/548/EEC
R-phrases 31-36/38
Contact with acids liberates toxic gas. Irritating to eyes and skin.
S-phrases 26-28-36/37-38
In case of contact with eyes, rinse immediately with plenty of water and seek
medical advice. After contact with skin, wash immediately with plenty of water.
Wear suitable protective clothes, gloves, and eye protection. In case of
insufficient ventilation wear suitable respiratory equipment.

16 Other information

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Revisions:2.0
Information of this Safety Data Sheet represents the today’s state of our knowledge. The purpose is to
characterise the product regarding safety precautions having to be kept. This document will not be a
certification of features and will not be the basis of a legal contract.

Page 18 of 18