QF502.03 (2.
0)
Document Security
Technical Document Confidential
Type Classification
Document No. Z-3300-018-SJ P. Code 003X
Print
Color Black
Requirement
糖化血红蛋白质控品安全数据表（英文）
Safety Data Sheet of Hemoglobin A1c
Control(English)
Reference Document(s)
Document No. Description
Document dispatch department: (according to the following
explanation)
1. Tooling, Fixture, all-purpose & Reagent doc must be filled
国际体外诊断产品市场部、检验试剂生产
in. 部、物流部
2. Confidential & Top secret doc. must be filled in, but only
for needing to release.
Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 1 of 9
Security Classification: Confidential Z-3300-018-SJ-2.0
Revision Record
Ver Software Ver Summary of Revision Reviser Effective Date
1.0 / Initial version Chen Huan 2015-06-04
Complementing the related transport
2.0 / Yang Honghao
regulation.
Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 2 of 9
Security Classification: Confidential Z-3300-018-SJ -2.0
Safety Data Sheet
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Product code 105-007859-00（CRL-1: 2mL×1, CRL-2: 2mL×1)
105-007860-00（CRL-1: 2mL×1)
105-007861-00（CRL-2: 2mL×1)
105-007862-00（CRL-1: 2mL×3, CRL-2: 2mL×3)
Product name Hemoglobin A1c Control
1.2 Relevant identified uses of the substance or mixture and uses advised against
Intended use Quality control over the test on HbA1c in whole blood to monitor and assess
the accuracy of the test result.
1.3 Details of the supplier of the Safety Data Sheet
Manufacturer/Supplier Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Street address/P.O. Mindray Building, Keji 12th Road South, Hi-tech industrial park, Nanshan,
Box Shenzhen 518057, P.R.China
Telephone number Tel: +86 755 81888998 Fax: +86 755 26582680
1.4 EC-Representative
EC-Representative Shanghai International Holding Corp. GmbH(Europe)
Address Eiffestraβe 80, 20537 Hamburg, Germany
Telephone number Tel: 0049-40-2513175 Fax: 0049-40-255726
1.5 Emergency telephone number
Opening hours Tel: +86 755 81888998 (Monday-Friday: 08:30-18:00 Beijing Time)
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
This product does not meet the criteria for classification in any hazard class according to Regulation (EC)
No 1272/2008 on classification, labelling and packaging of substances and mixtures.
2.2 Label elements
Labelling according to Regulation (EC) No 1272/2008 [CLP]
Hazard pictograms Not applicable.
Signal word: Not applicable.
Hazard statements: Not applicable.
Precautionary P501 Dispose of waste product, unused product, contaminated packaging in
statements accordance with governmental requirements.
2.3 Other hazards
This product does not contain any known PBT, vPvB, carcinogens, mutagens, reproductive toxicants as
listed by SVHC candidate list.
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Security Classification: Confidential Z-3300-018-SJ -2.0
This product was tested by reagents kit using ELISA methods and found non-reactive for Hepatitis B
Surface Antigen (HBsAg), antibody to Hepatitis C (HCV), antibody to HIV-1/HIV-2 and antibody to
Treponema Pallidum (TP). However, The risk of potential infection can be ruled out by no testing method,
this product should be handled as a potentially infectious material. In the event of exposure follow the
directives of the responsible health authorities.
Potential health
See Section 11 for more information.
effects
Potential
environmental See Section 12 for more information.
effects
SECTION 3: Composition/information on ingredients
3.2 Mixtures
REACH Classification according
Index
CAS No EC No Registration % [weight] Name to Regulation (EC) No
No.
No. 1278/2008 (CLP).
The content
Freeze-dried
concentrations
powder of
of products of
/ / / / whole blood Non-hazardous
different
matrix of
batches differ
people
slightly.
SECTION 4: First aid measures
4.1 Description of 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 and seek medical advice immediately.
Inhalation Not applicable.
Self-protection of Wear gloves and laboratory coat. Prevent skin and eye contacting.
the first aider
4.2 Most important symptoms and effects, both acute and delayed
No information available.
4.3 Indication of any immediate medical attention and special treatment needed
No information available.
SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable
CO2, extinguishing powder or water spray.
extinguishing media
Unsuitable
No information available.
extinguishing media
5.2 Special hazards arising from the substance or mixture
Not applicable.
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Security Classification: Confidential Z-3300-018-SJ -2.0
5.3 Advice for firefighters
Fire fighters should wear an approved self-contained breathing apparatus and full protective clothing.
SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
For non-emergency Wear gloves and laboratory coat. Prevent skin and eye contacting.
personnel
For emergency Wear full protective clothing.
responders
6.2 Environmental precautions
Keeping away from drains, surface and ground water.
6.3 Methods and material for containment and cleaning up
As a precautionary measure, treat spilled material with a 1:10 bleach/water solution. Absorb spill with
inert material (e.g. vermiculite, sand or earth) and place in containers suitable for disposal. Avoid
generation of aerosols during clean up. Dispose it in accordance with governmental requirements.
6.4 Reference to other sections
See Section 8 and 13 for more information.
SECTION 7: Handling and storage
7.1 Precautions for safe handling
Measures to prevent fire Not to smoke in work areas.
Measures to prevent aerosol Don't use a brush or compressed air for cleaning surfaces and protective
and dust generation clothing.
Measures to protect the Avoiding spills and keeping away from drains.
environment
Advice on general Not to eat, drink and smoke in work areas. Wash hands after use the
occupational hygiene product. Remove contaminated clothing and protective equipment before
entering eating areas.
7.2 Conditions for safe storage, including any incompatibilities
Store product at 2-8℃ and in the environment without corrosive gas and with good ventilation. Direct
sunshine should be avoided. Keep container closed.
7.3 Specific end use(s)
No more relevant information available.
SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational None established.
Exposure limit
values
8.2 Exposure controls
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Security Classification: Confidential Z-3300-018-SJ -2.0
Appropriate Use in well ventilated area. Keep away from foodstuffs, beverages and feed.
engineering controls Remove all soiled and contaminated clothing immediately. Wash hands before
breaks and at the end of work.
Eye and face Wear suitable safety goggles and face-shields.
protection
Skin protection Working environment required, wear suitable protective clothing to minimize
contact with skin.
Hand protection Wear appropriate protective gloves to reduce hand contact.
Respiratory Wear suitable protective mask.
protection
Thermal hazards No relevant information available.
Environmental Keep the working place well ventilated.
exposure controls
SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance Bronzing or sandy beige dried power.
Odour Odourless.
Odour threshold Not applicable.
pH ( 25±1 °C ) Not applicable. The product is dried power, not liquid.
Melting point / Not applicable. The product is dried power, not liquid.
freezing point
Initial boiling point No relevant information available.
and boiling range
Flash point No relevant information available.
Evaporation rate No relevant information available.
Flammability (solid, Not applicable. The product is not flammable or explosive.
gas)
Upper/lower Not applicable. The product is not flammable or explosive.
flammability or
explosive limits
Vapour pressure No relevant information available.
Vapour density No relevant information available.
Relative density No relevant information available.
Solubility(ies) Soluble.
Partition coefficient: No relevant information available.
n-octanol/water
Auto-ignition Not applicable. The product is not flammable or explosive.
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Security Classification: Confidential Z-3300-018-SJ -2.0
temperature
Decomposition No relevant information available.
temperature
Viscosity No relevant information available.
Explosive properties Not applicable. The product is not flammable or explosive.
Oxidizing properties No relevant information available.
9.2 Other information
No further information available.
SECTION 10: Stability and Reactivity
10.1 Reactivity
No data available.
10.2 Chemical stability
This product is stable under conditions specified by instruction for use and labels.
10.3 Possibility of hazardous reactions
No further relevant information available.
10.4 Conditions to avoid
Keep away from high temperature(above 8℃) and direct light.
10.5 Incompatible materials
No further relevant information available.
10.6 Hazardous decomposition products
No decomposition products posing significant hazards would be expected from this product.
SECTION 11: Toxicological information
11.1 Information on toxicological effects
Acute toxicity No further relevant information available.
Skin corrosion/irritation No further relevant information available.
Serious eye damage/irritation No further relevant information available.
Respiratory or skin No further relevant information available.
sensitisation
germ cell mutagenicity No further relevant information available.
carcinogenicity No further relevant information available.
reproductive toxicity No further relevant information available.
Summary of evaluation of the No further relevant information available.
CMR properties
STOT-single exposure No further relevant information available.
STOT-repeated exposure No further relevant information available.
aspiration hazard No further relevant information available.
Classified documents, its Intellectual Property belongs to Mindray Co. Ltd Page 7 of 9
Security Classification: Confidential Z-3300-018-SJ -2.0
SECTION 12: Ecological information
12.1 Toxicity
Acute (short-term) No further relevant information available.
toxicity
Chronic (long-term) No further relevant information available.
toxicity
12.2 Persistence and degradability
No further relevant information available.
12.3 Bioaccumulative potential
No further relevant information available.
12.4 Mobility in soil
No further relevant information available.
12.5 Results of PBT and vPvB assessment
Not applicable.
12.6 Other adverse effects
No further relevant information available.
SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product disposal The product is potential infectious substance. Dispose of waste product, unused
product in accordance with governmental requirements. To ensure compliance we
recommend that you contact the relevant(local) authorities and/or an approved
waste-disposal company for information.
Package disposal The product packaging is potential infectious material. Dispose of
contaminated packaging in accordance with governmental requirements. If
unsure of the applicable requirements, contact the authorities for information.
SECTION 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), of
information the International Maritime Dangerous Goods Code (IMDG), of the International
Air Transport Association (IATA) regulations,of European Agreement
concerning the International Carriage of Dangerous Goods by Inland Waterways
(ADN),and of ICAO Technical Instructions (ICAO).
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
EU regulations This SDS complies with EC Regulations 1907/2006 (REACH) and
amendments.
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Security Classification: Confidential Z-3300-018-SJ -2.0
TSCA: This product is not subject to TSCA.
SARA Title III: The components of this product are subject to the reporting
requirements of Section 302, 304 and 313 of SARA Title III, and are listed as
follows:
SARA SARA
SARA
302(40 CFR 304(40
Chemical Name 313(40 CFR
355, CFR Table
372.65)
Appendix A) 302.4)
Freeze-dried
powder of whole
US Federal No No No
blood matrix of
Regulations people
US CERCLA REPORTABLE QUANTITY(RQ): None
US SARA THRESHOLD PLANNING QUALITITY: There are no specific
Threshold Planning Quantity for the components of this product. The default
Federal MSDS submission and inventory requirement filling threshold of
10,000 lbs(4,540kg) therefore applies per 40 CFR 370.20.
OTHER US FEDREAL REGULATIONS: Not applicable.
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT
ACT (PROPOSITION 65): This product and its components are not on the
Proposition 65 lists.
CANADIAN DSL/NDSL INVENTORY STATUS: The components of this
product are on the DSL or NDSL Inventories.
Canadian Ingredient Disclosure List (limit 0.1%): None of the ingredients is
Canada listed.
Canadian Ingredient Disclosure List (limit 1%): None of the ingredients is
listed.
15.2 Chemical Safety Assessment
No Chemical Safety Assessment has been carried out for this substance/mixture.
SECTION 16: Other information
Prepared Date (year/month/day): 2015/06/04 Revised Date (year/month/day):2016/01/13
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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