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YY 0648-2008: Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
YY 0648-2008
Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
YY 0648-2008/IEC 61010-2-2101..2002
Safety of electrical equipment for measurement, control and laboratory use
Requirements Part 2-101. In Vitro Diagnostics (I 犞 D)
Specific requirements for medical equipment
(IEC 61110-2-2101..2002, IDT)
Published in.2008-04-25
Implemented in.2009-12-12
Published by the State Food and Drug Administration
Foreword
The entire content of this standard is mandatory.
This standard is equivalent to adopting the international standard IEC 6110-2-10..2002 "Safety requirements for electrical equipment for measurement, control and laboratory use.
Part 2-101. Particular Requirements for In Vitro Diagnostic (IVD) Medical Devices (English version), its technical content and structure are in accordance with IEC 6110-2-11
with. GB 47.93.1 "Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 1. General requirements" has been used equivalently
Content of IEC 61110-1..2001 and Technical Corrigendums 1 and 2. Consistent with GB 4973.1-2007, omitting IEC 6110-2-101..2001
Preface and the contents of "Appendix H Definition Index".
This standard modifies 5.4.4b) (see 6.12) of the IEC 61101-2-101..2002 standard to (see 6.11), because IEC 6110-10.
There is no such clause in.2001 and GB 4973.1-2007; this standard should be used in conjunction with GB 4973.1-2007.
The "applicable" part of this standard indicates that the corresponding clauses in GB 4973.1-2007 are applicable to this standard;
The "replacement", "modification" or "deletion" parts are subject to the provisions in this standard; the "addition" part in this standard indicates
In addition to the corresponding provisions in GB 4793.1-2007, it must also meet the provisions added in this standard.
Appendix BB of this standard is a normative appendix, and Appendix AA is an informative appendix.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the Standardization Technical Committee for In vitro Diagnostic Systems.
This standard was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Zeng Ning, Han Xiaopeng, Zhang Zhaoyuan.
YY 0648-2008/IEC 61010-2-2101..2002
Safety of electrical equipment for measurement, control and laboratory use
Requirements Part 2-101. In Vitro Diagnostics (I 犞 D)
Specific requirements for medical equipment
1 Scope and purpose
Except for the following, this chapter in GB 47.93.1 applies.
1.1 Scope
replace.
This standard applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-testing in vitro diagnostic medical purposes.
In vitro diagnostic medical devices, whether used alone or in combination, are intended to be used by manufacturers for the examination of in vitro samples, including those from humans
Blood and tissue samples from individuals, whose sole or main purpose is to provide information for one or more of the following.
● a physiological or pathological condition; or
● a congenital anomaly;
● determine the safety and compatibility of potential receptors;
● Monitoring of treatment measures.
Self-testing in vitro diagnostic medical devices are intended for use by manufacturers in non-professional home environments.
Note. If all or a part of the equipment belongs to the scope of this standard, and also belongs to the scope of one or several other GB 4793 special standards, this equipment
Equipment also needs to meet the requirements of those other specific standards.
1.1.2 Equipment not covered by this standard
increase.
Add the second paragraph below.
Products used in general laboratories are not in vitro diagnostic medical devices, unless they are specifically expected by the manufacturer based on their characteristics
For in vitro diagnostic tests.
1.2 Purpose
1.2.1 Contents included in the scope of this standard
replace.
Replace the first sentence with the following.
The purpose of this standard is to ensure that the design and construction methods used are at an acceptable level of risk for the operator and the surrounding environment.
Provide a high degree of protection and use risk management where appropriate (see Appendix AA).
increase.
Add two new entries.
h) biological hazards;
i) Hazardous chemicals.
1.2.2 Contents not included in the scope of this standard
increase.
Add a new entry and the following note.
g) Treatment or manipulation of the material being analyzed outside the equipment.
Note. The requirement to cover these disciplines is the responsibility of the committee that develops the appropriate standards.
YY 0648-2008/IEC 61010-2-2101..2002
2 Normative references
Except for the following, this chapter in GB 47.93.1 applies.
increase.
ＹＹ/T 0316-2003 Application of medical device risk management to medical devices
3 Terms and definitions
Except for the following, this chapter in GB 47.93.1 applies.
3.1 Types of equipment and equipment
Added definition.
3.101
Physical harm or violation of human health, or damage to property or the environment.
[ISO /IEC Guide 51..1999, Definition 3.3]
3.102
The combination of the probability of damage and the severity of the damage.
[ISO /IEC Guide 51..1999, Definition 3.2]
3.103
Acceptable risks in a specific context based on current values of society.
[ISO /IEC Guide 51..1999, Definition 3.7]
Note 1. Permissible risk is the ideal of absolute safety, the requirements to be met by a product, process or service, and benefits such as user benefits, suitability of purpose,
Balance of cost efficiency, risk assessment, relevant social habits and technical level.
Note 2. The term "acceptable risk" in Y/T 0316 is used in the same sense as the allowable risk.
3.104
Products, processes, or services are not used in the way the supplier expects, but this can be generated by easily predictable human behavior.
[ISO /IEC Guide 51..1999, Definition 3.14]
3.105
It can only be removed using tools or appropriate force, and can withstand the temperature, friction, common solvents, reagents and
The effect of steam.
3.106
A callout, text or a graphic symbol is permanently attached to the product.
4 Test
Except for the following, this chapter in GB 47.93.1 applies.
4.4.1 Overview
replace.
Replace entry a) in the first paragraph.
a) Equipment and circuit diagrams should be checked to determine what may occur and may occur during normal use and reasonably foreseeable misuse
YY 0648-2008/IEC 61010-2-2101..2002
Causes dangerous fault conditions.
delete.
Remove the first dash.
increase.
Added terms.
4.4.2.1 Wrong voltage selection
Multi-voltage equipment that can be set to different supply voltages by the operator should be set to each voltage in turn and then connected to
All other rated supply voltages.
5 Signs and documents
Except for the following, this chapter in GB 47.93.1 applies.
5.1.1 Overview
replace.
Replace the third paragraph with the following.
Quantitative and unit text symbols shall be in accordance with IEC 60027. Wherever possible, internationally recognized symbols including Table 1 should be used
number. If other additional symbols are required, it shoul...