Security Classification: Confidential Z-3107-005-SJ-2.

Chemicals Safety Technology Manual

PartⅠ Diluent
1 Chemicals and Enterprise Label
Product Information

Product code M-52D DILUENT: 105-004045-00 (20L×1)

Product name/Model DILUENT/M-52D

Intended use It is use for in vitro diagnostic, see the product label for details.

Manufacturer Information

Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

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

Tel: +86 755 81888998 / Fax: +86 755 26582680

Emergency call Tel: +86 755 81888998 / Fax: +86 755 26582680 (Mon-Fri: 08:30-18:00 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 Component/Composition
Components Components concentration

BorateBuffer ≤0.5%

Sodium Chloride ≤0.1%

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 Not applicable.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 1 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0

5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media Not applicable.
Special exposure Not applicable.
hazards
Protective equipment Not applicable.
for fire-fighters

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 Absorb spill with inert material (e.g. vermiculite, sand or earth), then place in
cleaning up suitable container. Dispose it in accordance with governmental requirements.

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 Transparent liquid.
Odour Odourless.
pH ( 25±1 °C ) 7.35±0.20;
Melting point 0 °C
Boiling point 100 °C.
Flash point Not applicable.
Explosive properties Not explosive.
Oxidizing properties Not applicable.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 2 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0

Autoignition Not applicable.

temperature
Vapour pressure No information available.
Relative density Not applicable.
Specific gravity 1.00-1.05 g/mL.
(20 °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.
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.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 3 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0

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:1.0
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.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 4 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0

PartⅡ Lyse
1 Chemicals and Enterprise Label
Product Information

Product Code M-52DIFF LYSE: 105-003724-00 (500mL×4)

105-004461-00 (500mL×1)

M-52LH LYSE: 105-004307-00 (100mL×4)

105-004463-00 (100mL×1)

Product Name/Model Lyse /M-52DIFF,M-52LH

Intended Use It is use for in vitro diagnostic, see the product label for details.

Manufacturer Information

Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

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

Tel: +86 755 81888998 / Fax: +86 755 26582680

Emergency call Tel: +86 755 81888998 / Fax: +86 755 26582680 (Mon-Fri: 08:30-18:00 Beijng Time)

2 Hazard 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 Component/composition
components Trade name Components & Concentration
M-52 DIFF Surfactant (＜35g/L)

M-52 LH Quaternary ammonium salts (＜50g/L)，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.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 5 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0

Inhalation Not applicable.

5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media Not applicable.
Special exposure Not applicable.
hazards
Protective equipment Not applicable.
for fire-fighters

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 Absorb spill with inert material (e.g. vermiculite, sand or earth), then place in
cleaning up suitable container. Dispose it in accordance with governmental requirements.

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 Transparent liquid.
Odour Slightly smell of surfactant .
pH (25±1 °C) M-52DIFF LYSE 4.20±0.20
M-52LH LYSE 2.20±0.20

Melting point 0 °C.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 6 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0

Boiling point 100 °C.

Flash point Not applicable.

Explosive properties Not applicable.

Oxidizing properties Not applicable.

Autoignition Not applicable.
temperature
Vapour pressure No information available.
Relative density Not applicable.
Specific gravity 1.00-1.25 g/mL.
(20 °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.
Materials to avoid No information available.
Hazardous No information available.
decomposition
products

11 Toxicological information
Toxicokinetics, metabolism and distribution No experimental data for this preparation available.
Acute toxicity No experimental data for this preparation available.
Corrosivity/irritation No corrosive/irritant effect.
Sensitisation No experimental data for this preparation available.
Repeated-dose toxicity No experimental data for this preparation available.
Carcinogenicity/Mutagenicity/Reproducitive No experimental data for this preparation available.
toxicity

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

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 7 of 13
 Security Classification: Confidential Z-3107-005-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.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 8 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0

Part Ⅲ Probe Cleanser

1 Chemicals and Enterprise Label
Product information

Product code 105-002225-00（50mL）

Product Name/Model Probe cleanser

Intended Use It is use for in vitro diagnostic, see the product label for details.

Manufacturer Information

Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

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

Tel: +86 755 81888998 / Fax: +86 755 26582680

Emergency call Tel: +86 755 81888998 / Fax: +86 755 26582680 (Mon-Fri: 08:30-18:00 Beijng Time)

2 Hazard 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 It is corrosive to the skin and will burn the skin and the eyes.

Environmental See Part 12 for more information.

hazards
Physico-chemical No information available.
hazards
Other hazards Contact with acids liberates toxic gas.

3 Component/Composition
Components Components concentration
Surfactant ≤0.2%;

Sodium hypochlorite ≤12%

Sodium hydroxide ≤5%

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.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 9 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0

Inhalation Remove to fresh air. If symptoms persist contact a physician.

5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media Not applicable.
Special exposure Not applicable.
hazards
Protective equipment Not applicable.
for fire-fighters

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.

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 -8 °C.

Boiling point 100 °C.
Flash point Not applicable.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 10 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0

Explosive properties Not explosive.

Oxidizing properties Oxide.
Autoignition Not applicable.
temperature
Vapour pressure No information available.
Relative density Not applicable.
Specific gravity 1.00-1.25 g/mL.
(20 °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 decomposable on high temperature.
Conditions to avoid High temperature.
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

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 11 of 13
 Security Classification: Confidential Z-3107-005-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 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.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 12 of 13
 Security Classification: Confidential Z-3107-005-SJ-2.0
Wear suitable protective clothes, gloves, and eye protection. In case of
insufficient ventilation wear suitable respiratory equipment.

16 Other information
Revisions:1.0
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.

Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 13 of 13